Sleepkey - Drug-Free Solution from PICS, Inc. for Insomnia Sufferers Uses Technology to Bring Restful Sleep

Drug-Free Solution from PICS, Inc. for Insomnia Sufferers Uses Technology to Bring Restful Sleep

RESTON, Va.--(BUSINESS WIRE)--Feb. 8, 2006--Approximately 30 million Americans suffer from chronic insomnia. Many of these people do not seek help for their sleep problems, while others rely on medications to help them sleep. Unfortunately, most of these approaches are not long-term solutions. The National Institutes of Health (NIH) released a State-of-the-Science statement concluding that cognitive behavioral therapy (CBT) is one of the most effective long-term treatments for chronic insomnia. In the past, insomnia sufferers have not had the option of behavioral therapy in the comfort of their homes. A new product called SleepKey(TM) developed by PICS, Inc. is designed to bridge this gap by delivering CBT as a self-help modality. 

SleepKey is a small handheld computer that works by first learning the user's unique sleep pattern and then applying behavioral principles to modify and consolidate sleep behavior. SleepKey utilizes active sleep sampling to determine the user's sleep pattern. The SleepKey system produces a low tone or vibration periodically throughout the night, and determines whether the user is asleep based on a response to these prompts. After assessing the user's sleep pattern for 7 days, SleepKey schedules a bedtime each night based on a sleep restriction algorithm used by sleep clinicians. As the percentage of time asleep improves, the time to bed is gradually adjusted until the user is getting a full night's sleep. By restricting the time in bed and prompting the user to get out of bed if not asleep after a period of time, SleepKey helps users break the associations of the bed being a place of restlessness rather than a place for sleeping.

SleepKey is scientifically based and its development was funded in part with grants from the National Heart, Lung, and Blood Institute of the National Institutes of Health. SleepKey has been shown in two studies to quickly improve several measures of sleep quality. The development of SleepKey was led by Dr. William T. Riley, Director of Research of PICS in consultation with leading authorities on the behavioral treatment of insomnia including Dr. Charles Morin of Universite Laval and Dr. Jack Edinger of Duke University.

For more information, call 1-888-8SLEEPKEY or visit www.SleepKey.com.

PICS, Inc. is a Reston, VA based research and development company that specializes in the use of computer technology to assess and improve health behaviors such as insomnia, tobacco use, diet, and exercise. With a 22-year track record and receiving over 50 grants from the National Institutes of Health, PICS, Inc. strives to build products that combine applied science and technology to help individuals live longer and healthier lives.

AMERICANS MAY BE RELYING TOO HEAVILY ON SLEEPING PILLS WHEN SAFER REMEDIES ARE AVAILABLE

New report identifies side effects, examines effectiveness of top insomnia medications; DTC advertising contributes to increased use of sleep drugs, says CU's President

YONKERS, NY – Americans with insomnia may be relying too heavily on sleeping pills instead of trying safer non-drug remedies, according to a new report from Consumer Reports Best Buy Drugs, which recommends that consumers who take sleeping pills do so for the shortest period possible because of the risk of side effects and misuse.

The September 2006 issue of Consumer Reports finds that in 2005 use of sleeping drugs in the United States is generally correlated to the growth in direct-to-consumer advertising of sleep medications. Pharmacists filled 43 million prescriptions for sleep drugs in 2005, a 32 percent increase from 2001. Prescription insomnia medications brought pharmaceutical companies more than $2.7 billion in 2005. Both the Consumer Reports story on sleep medications and the CR Best Buy Drugs insomnia report are available free at www.ConsumerReports.org/health.

“Sleeping pills are best taken for the short term, and only if they are really needed,” said Marvin M. Lipman, M.D., Consumers Union’s Chief Medical Adviser. “The advertisements for these drugs may be lulling too many people into believing that these medicines can be taken regularly without consequence.”

The CR Best Buy Drugs report notes that newer sleeping pills do have side effects. These range from minor, such as dizziness and day-after sleepiness, to the more serious, such as cognitive impairment, dependency and rebound insomnia, in which symptoms return or even worsen after the person stops taking the pills. There have also been reports of short-term memory loss, sleep walking, and sleep driving when taking sleeping pills; though rare, some people may be susceptible to those effects. Such rare effects also may be exacerbated by combining sleeping pills with alcohol.

The report urges people to talk with their doctors about whether they really need a pill. People who have chronic insomnia – trouble sleeping three or more nights a week for at least a month – should try behavioral therapy that improves sleep habits and attitudes toward sleeping and bedtime. Some studies show this treatment provides greater benefits than pills over the long term, though chronic insomnia sufferers may have to occasionally take sleeping pills.

The four newer medicines to treat insomnia – Ambien and Ambien CR, Lunesta, Sonata and Rozerem – are effective at helping people get to sleep and stay asleep, but not necessarily better than older, less-expensive drugs for many people who need a sleep aid for a night or two, the report found. Those include non-prescription products, such as Nytol and Tylenol PM, that contain antihistamines, or older prescription sedatives called benzodiazepines, such as Dalmane (flurazepam) or Restoril (temazepam). The report selected Ambien (zolpidem) as a Best Buy, based primarily on the fact that it is slated to become available as a generic in October. Fifteen doses of Ambien now cost around $58; when it becomes generic, that price is expected to decline 50 percent to 70 percent.

Consumers Union’s President Jim Guest states, “Consumers deserve unbiased, accurate information about how well drugs work, their risks, and whether they’re worth the cost. Today’s drug ads drive up health-care costs, overstate the value of pills, and underplay the dangers of new drugs that have not been proved safe over time. The pharmaceutical industry should stop the hype and give consumers additional and more relevant facts,” he said.

The Consumer Reports article cites the recent ad blitz as a factor driving the sales of sleep drugs. For example, Lunesta’s manufacturer, Sepracor, which introduced the drug in April 2005, spent $227 million on advertising that year. Prescriptions for Lunesta totaled 98,471 in April 2005; by December, that number more than quadrupled to 477,877. Lunesta was the most frequently advertised prescription drug in the United States last year, likely prompting the market leader, Ambien, to buy more advertising time and inundate consumers with sleep drug advertisements. Ambien is the 14th-most prescribed drug in the country.

Consumer Reports Best Buy Drugs www.CRBestBuyDrugs.org is a free, public education project that identifies effective, safe and affordable medicines based on the scientific evidence. The report is the latest in a series that identifies cost-effective drugs for such problems as high blood pressure, high cholesterol, heartburn, menopause, depression, allergies and pain.

Contact: Susan Herold, 202-462-6262

©1998-2005 Consumers Union

Record Sales of Sleeping Pills Are Causing Worries

By STEPHANIE SAUL, The New York Times.

Americans are taking sleeping pills like never before, fueled by frenetic workdays that do not go gently into a great night's sleep, and lulled by a surge of consumer advertising that promises safe slumber with minimal side effects.

About 42 million sleeping pill prescriptions were filled last year, according to the research company IMS Health, up nearly 60 percent since 2000.

But some experts worry that the drugs are being oversubscribed without enough regard to known, if rare, side effects or the implications of long-term use. And they fear doctors may be ignoring other conditions, like depression, that might be the cause of sleeplessness.

Although the newer drugs are not believed to carry the same risk of dependence as older ones like barbiturates, some researchers have reported what is called the "next day" effect, a continued sleepiness hours after awakening from a drug-induced slumber.

Ten percent of Americans report that they regularly struggle to fall asleep or to stay asleep throughout the night. And more and more are turning to a new generation of sleep aids like Ambien, the best seller, and its competitor, Lunesta. Experts acknowledge that insomnia has become a cultural benchmark — a side effect of an overworked, overwrought society.

"Clearly, there's a significant increase in people who report insomnia and, from my perspective, that is the result of our modern-day lifestyle," said Dr. Gregg D. Jacobs, a psychologist and assistant professor of psychiatry at Harvard. Or at least that is an impression that drug makers are clearly trying to capitalize on, he said.

And that concerns him and some other researchers who warn that despite their advertised safety, the new generation of sleep aids can sometimes cause strange side effects.

The reported problems include sleepwalking and short-term amnesia. Steven Wells, a lawyer in Buffalo, said he started using Ambien last year because his racing mind kept him awake at night. But he quit after only one month, concerned about several episodes in which he woke up to find he had messily raided the refrigerator and, finally, an incident in which he tore a towel rack out of a wall.

"The weird thing was that I had no recollection of it the next day," said Mr. Wells, who added that he found the episodes frightening.

Ambien's maker, Sanofi-Aventis, said the drug had been used for 12 billion nights of patient therapy. "When Ambien is taken as prescribed, it's a safe and effective treatment," said Emmy Tsui, a company spokeswoman.

A Food and Drug Administration spokeswoman, Susan Cruzan, said she was not aware of an unusual number of complaints with the drugs.

Drug makers spent $298 million in the first 11 months of 2005 to convince consumers that the sleep aids are safe and effective. That was more than four times such ad spending in all of 2004.

In the last year, much of the advertising surge has been a result of competition from Lunesta, which the drug maker Sepracor introduced last April to compete with Ambien. Through November, Sepracor led the sleeping pill advertising field, spending more than $185 million, according to figures from TNS Media Intelligence, which did not have final figures for December.

In response, Sanofi-Aventis, marketing both Ambien and its controlled-release version, Ambien CR, spent $107 million from last January through November, according to TNS. That was nearly double its ad spending on Ambien in 2004.

Even the most infrequent television viewers would have trouble missing the Lunesta ads, which feature a luna moth fluttering around the bed of a peaceful sleeper. Dr. Jacobs said that in one hour of prime-time television recently, he saw three ads for sleeping pills: two for Lunesta and another for Ambien.

"You've got the patient population being bombarded with advertising on TV," Dr. Jacobs said. "You've got increased advertising to physicians. You've got a formula for sales going up dramatically."

One financial analyst, Jon LeCroy of Natexis Bleichroeder, said Lunesta's ad campaign last fall was tied to the new season of "Desperate Housewives," whose audience is about 55 percent female. Studies have shown that women have insomnia more frequently than men.

Last week, Sepracor's stock jumped $8.53 in one day, after Sepracor reported a profit and remarkably strong use of Lunesta in its first year on the market, with sales of $329 million. More than 213,000 doctors wrote 3.3 million prescriptions for it last year, the company says.

Sepracor announced the addition of 450 people to its current sales force of 1,500 to increase marketing of the drug to physicians.

Sanofi-Aventis, with a sales force of 3,000, is working to shift patients from Ambien, which loses its patent protection in October, to the newer version, Ambien CR. The newer pill has a quickly dissolving outer layer meant to immediately induce sleep, with a slower-dissolving inner layer to sustain sleep.

Another drug in the class is Sonata, marketed by King Pharmaceuticals. Because it is short acting, Sonata is recommended for people who have trouble falling asleep but no trouble staying asleep.

Drugs in the class are frequently referred to as "Z" drugs, a play on both their effect and the Z's in their generic names, like zolpidem (Ambien) and eszopiclone (Lunesta). All aim at a brain neurotransmitter that is believed to reduce neural activity.

Another new entrant to the market, Rozerem, by the Japanese company Takeda Pharmaceuticals, has been available in drugstores since September but has not yet been heavily advertised. The drug works by a different mechanism from the others, acting on the brain's melatonin receptors, which are believed to play a role in sleep-wake cycles.

Mr. LeCroy, the analyst, who is also a medical doctor, predicts the advertising will intensify if Neurocrine Biosciences and its partner Pfizer are permitted to introduce their new sleeping pill, Indiplon; an F.D.A. decision on that is expected in May.

"That's going to make the competition get more cutthroat," Mr. LeCroy said, predicting that the market for branded sleeping pills, currently about $2 billion a year, could grow to $3.8 billion, even with Ambien set to go generic. "This is only going to get crazier."

The Carlat Psychiatry Report, a newsletter by Dr. Daniel J. Carlat, a psychiatrist in Newburyport, Mass., reviewed the Z drugs recently and concluded that their differences were merely subtle. But Dr. Carlat warned that Lunesta, because it was longer acting, was more likely to cause next-day sleepiness problems "in comparison with some of its cousins."

Dr. Carlat cited a 1998 study in Britain, published in The Lancet, which found that taking zopiclone, the compound known as the "mother" of Lunesta and marketed in Europe, was linked to an increased risk of automobile accidents.

But Sepracor's chief financial officer, David P. Southwell, said that Lunesta, while a chemical variant of zopiclone, was a totally different drug. He referred a reporter to the F.D.A.-approved label, which lists clinical studies of next-day effects showing there was no consistent pattern of impaired mental functioning the day after Lunesta use.

The possible role of Ambien was investigated in connection with well-chronicled transportation disasters in 2003 — the crash of the Staten Island Ferry, which killed 11 passengers, and an accident involving a Texas church bus in Tallulah, La., which killed 8 passengers. The assistant captain who was piloting the ferry, like the bus driver, had a prescription for Ambien, but there was no evidence either had taken it before the crashes.

Dr. David G. Fassler, a clinical professor of psychiatry at the University of Vermont College of Medicine, said he was concerned that the heavy marketing and prescribing of the sleep medications would lead to use in patients who have underlying conditions that are left untreated.

"I'm concerned that difficulty sleeping can be a sign of multiple disorders, including problems with anxiety and depression," he said, expressing worry that patients who are not thoroughly evaluated might be treated for their insomnia while other problems, like anxiety or decreased appetite, are not addressed.

In clinical trials, the most common side effect of the drugs, however, is that people wake up feeling sleepy the next day.

Dr. Daniel J. Buysse, a University of Pittsburgh psychiatrist who has consulted for the industry on sleeping pills, said they were a rare example of drugs in which the desired effect and the major side effect were the same thing. "One occurs when you want it, and the other occurs when you don't," he said.

Panel touts therapy over drugs for insomnia

By The Washington Post

Most drugs prescribed for chronic insomnia have not been approved for that purpose or studied for long-term use, reported a panel of scientists gathered at the National Institutes of Health. They said behavioral and cognitive therapies are often effective but underused.

Chronic insomnia is marked by frequent difficulty falling asleep or waking too often or too early for at least 30 days. Untreated, the condition can affect social functioning and interfere with daily life. About 30 percent of adults deal with sleep disruption, and chronic insomnia is their most common complaint.

According to the panel, cognitive behavioral therapy (CBT) can be as effective as prescription drugs, without the danger of side effects. The treatment combines relaxation and talk therapy. But drugs remain the most popular treatment, the panel found. The most prescribed medication is the antidepressant Desyrel, which has not been approved by the Food and Drug Administration for treatment of insomnia and whose long-term side effects are unknown, according to the panel.

Approved for insomnia are Ambien, Sonata and Lunesta, but they too "have short-term benefits, and the real gap is for long-term treatments," said Sean Caples, a panel member who practices sleep medicine at the Mayo Clinic in Rochester, Minn., in an interview. Over-the-counter antihistamines are also inappropriately used, the panel said.

Insomnia is usually linked to stress, anxiety, consumption of caffeine or alcohol, and sometimes to medical conditions such as depression.

Self-reporting and a physical exam by a specialist is usually enough to diagnose the condition, but pills are not the first remedy for some physicians. James Yen, medical director of the National Capital Sleep Center at Suburban Hospital in Maryland, starts with "sleep hygiene" lessons, including daily exercise, caffeine restrictions and a sleeping schedule. This works for 40 to 50 percent of patients; for others he prescribes mild drugs such as Ambien and then, if needed, antidepressants. "If none of this works," he said, "I'll refer them to a psychologist or psychiatrist."

Alan Leshner, panel chair, encouraged patients to ask for CBT before swallowing drugs. "We hope that the public will be more selective" with both over-the-counter and prescription medication, he said.


Losing Sleep? Insomnia got you rumpling the sheets? Drug companies are taking note 

By Helen Fields, U.S. News & World Report, 10/24/05

You stare at the ceiling. You try to ignore the clock. You consider your son's lousy report card. You avert your eyes from the clock. Your mind latches onto the next day's PowerPoint presentation. Too many bullets? Too few? Oops--you look at the clock. Aargh . . . even if you fall asleep right now, you're only going to get five hours of sleep. You'll be exhausted tomorrow, you'll lose your job, you won't be able to pay the mortgage, your kids will land on the street, and omigod, now it's only 4 1/2 hours.

Insomnia is nothing new. Cave men probably agonized about being too tired in the morning to catch a really good mammoth. But many sleep specialists suspect--no one can say for sure--that a world that offers TV, 24/7 interconnectivity, and boundless workdays is swelling the insomniac population. Insomnia increasingly is being viewed as a medical problem, drawing a new generation of pills and talk therapy. Sleep drugs claimed to be free of the grogginess and addiction risk of older potions are flooding the market, with more to come. And cognitive-behavioral therapy, widely used in other disorders, is being wielded against insomnia.

Insomnia isn't just an inability to fall asleep; it's more like an inability to sleep well. The classic insomniac lies in bed, wide-eyed, before managing to drift off. Another awakens during the night and can't go back to sleep, while still another snoozes straight through but wakes up unrefreshed. Insomnia may be linked to bigger health problems. Insomniacs are more likely to suffer from intractable, worsening pain, more likely to have accidents, and more likely to be diagnosed at some point with depression. And insomnia can indicate other health problems, such as sleep apnea.

Pill popping. Sleep drugs have joined Viagra, Botox, and other "lifestyle drugs" that target well-being rather than disease. In the first seven months of 2005, nearly 25 million prescriptions for sleep medications were filled, according to IMS Health, which tracks such statistics. And the number of adults ages 20 to 44 who took prescription sleep medications doubled between 2000 and 2004, according to a survey released this week by Medco Health Solutions, a manager of drug benefit programs. The market for the drugs should become even livelier as geared-up ad campaigns urge bleary-eyed consumers to bug their doctors.

Current sleep medications aren't as miraculous as their marketing suggests, but they're far superior to barbiturates--deadly when mixed with alcohol and with a low threshold for overdosing--and most sleep experts consider them improved over sleep inducers such as Halcion and Restoril that were introduced in the 1970s and 1980s. Those drugs boost the activity of a receptor molecule on the surface of brain cells, setting off a chain reaction that damps down brain activity and brings on sleep. They can make patients feel woozy and lose coordination, and are classified as controlled substances because of their potential to be habit-forming.

The newest drugs on the market--Ambien CR, Sonata, and Lunesta--affect brain chemistry the same way but are choosier about the receptors they target. Their side effects are generally milder than those of older drugs, and the risk of psychological dependence seems lower, but they are still classified as controlled substances. More such drugs are coming--Indiplon, for example, could be approved by the Food and Drug Administration and available by next summer.

Different drugs work better on different kinds of insomnia. Sonata, for instance, spikes quickly and then falls off steeply, so it may be best suited to insomniacs who need help falling asleep but don't wake up after that. This month, Sanofi-Aventis launched a slower-acting, longer-lasting version of Ambien, the top-selling prescription sleep medication. Ambien CR (for controlled release) is aimed at those who toss and turn all night or who wake up and can't go back to sleep. A slow-release version of Indiplon will be marketed for the same purpose.

Zero abuse. Rozerem, which became available late last month, is the first prescription sleep drug that has no potential for abuse and thus isn't listed as a controlled substance. It binds to receptors on cells in the brain's master clock, called the suprachiasmatic nucleus, triggering the cells to stop sending out the signal that keeps the brain awake. The drug is probably more useful for falling asleep than staying asleep, says psychiatrist Daniel Buysse, who studies sleep at the University of Pittsburgh Medical Center, but it will take a while to see how well it works compared with other drugs.

Many physicians resist prescribing sleep drugs because how patients will react over the long haul is unknown--the clinical trials that lead to a medication's approval last only a few months, while people may take the drug for years. "There's just kind of a disconnect," says Buysse.

The medication most commonly prescribed for insomnia is not a sleep drug at all but low-dose trazodone, an antidepressant. It's a legal but "off label" use, since the drug was approved for depression, not insomnia, and, again, its long-term effects on insomnia patients are an open question. "We just don't know anything," says Thomas Roth, a sleep researcher at Henry Ford Hospital in Detroit. He notes that because of side effects at high doses, the drug is rarely prescribed now for depression.

Dosing insomnia with over-the-counter products like Benadryl and Tylenol PM often produces next-day grogginess (the active ingredient is usually the same antihistamine that the manufacturer uses in its cold products), not to mention occasional constipation and, in some elderly people, delirium. And taking such medications for a long time has unknown effects.

A synthetic version of melatonin, a hormone that is part of the body's sleep mechanism, is a popular alternative therapy for insomnia. But a recent research review found that it doesn't seem to work for insomnia. Valerian root, an herbal supplement, supposedly has sleep-inducing qualities, but the evidence is shaky. (A current trial may give answers next year.)

Booze for a snooze? The good ol' nightcap has a long tradition of fighting insomnia--or trying to. Alcohol, a depressant, might induce sleepiness initially, but it will most likely wake you up later. "As it clears your system, you rebound," Roth says, and your sleep gets worse. "If I put an IV line and put alcohol in your system all night long, you'd do fine." (Your doctor may not agree.)

But drugs aren't the only way to attack a problem whose source is the brain. As sleep centers multiply, evolving from their academic roots to include freestanding centers and units at private hospitals, many have started offering cognitive-behavioral therapy. In widespread use for treating problems such as obsessive-compulsive disorder, depression, and addiction, this therapy helps a patient recognize fears that are out of proportion and develop tools to gradually erode them, says Edward Stepanski, a clinical psychologist and director of the Sleep Disorders Service and Research Center at Rush University Medical Center in Chicago.

Among those concerns, says Stepanski, is the fear of terrible health and personal consequences if someone doesn't fall asleep right away--a notion reinforced by widely reported studies on the importance of a full night's sleep. The anxiety only reinforces the insomnia. "Lying in bed thinking, 'I'm going to get fired if I don't get to sleep in the next half-hour,' is counterproductive," says Stepanski.

Therapy can also help patients understand that the tactics they may be using with increasing desperation to manage their sleep probably just make matters worse, says Jack Edinger, a clinical psychologist at the Veterans Affairs and Duke University medical centers in Durham, N.C. Naps, for instance, only scramble the body's internal clock, as does trying to catch up on sleep by going to bed earlier or getting up later.

Take an individual who thinks she needs eight hours of sleep every night. In fact, she may need only seven hours, but if she believes otherwise, the quality of her sleep may be disrupted to the point that she's getting just five or six good hours. Edinger would help someone like her work out a schedule that retrains her by establishing the correct amount of sleep she needs and by limiting the time she spends in bed. "We don't give them a lot of extra time to spin their wheels," he says. "It's not rocket science."

Drugs or therapy--which is better? "The question always makes me crazy," Roth says. "If somebody has elevated cholesterol, do you put them on statins or do you change their diet? You put them on a statin, and you say, 'Stop eating pork rinds.' Both things make you better." A study published last year in the Archives of Internal Medicine found that cognitive-behavioral therapy worked better than Ambien and helped patients more in the long term. But therapy isn't right for everyone. It's expensive, and drugs are usually the better choice for short-term problems like jet lag or stress from a death in the family, says Edinger. But drugs have side effects, so if your insomnia has a long history, many specialists suggest trying therapy first.

Whatever causes your insomnia, it can be treated, says Edinger: "Although insomnia can be a chronic disorder, that doesn't mean that the person has to have it forever. It's just that they haven't yet found a way to get over it."

 

Sleep Treatments for Older Adults
Study Shows Behavioral Treatments for Insomnia Are Effective

By Salynn Boyles
WebMD Medical News

Reviewed By Ann Edmundson, MD
on Wednesday, December 21, 2005

Dec. 21, 2005 -- Behavioral approaches to treating insomnia work in older adults, a new analysis suggests.

The review of 23 previously reported studies challenges the notion that older adults may be less responsive than other age groups to behavioral treatments for chronic sleep problems, says researcher Michael Irwin, MD.

Irwin added that behavioral treatments offer advantages over drugs because they can be used for longer periods. Although the new generation of sleep drugs is increasingly being used in this way, he says their long-term safety and effectiveness have not been well studied in older patients.

Irwin is a professor of psychiatry at the UCLA Neuropsychiatric Institute.

"There has been a push, driven in part by the pharmaceutical industry, toward using drugs for the long-term management of insomnia," he tells WebMD. "But the data to support the efficacy of this approach is very limited."

Sleep Problems Common

Chronic insomnia is common among older adults. This is defined by the American Psychiatric Association as a person who has trouble falling or staying asleep at least three nights a week. In addition, the lack of sleep causes daytime problems such as tiredness and difficulty concentrating. The researchers write that as many as a quarter of this age group have chronic sleep problems, with trouble falling asleep and frequent waking during the night among the most common complaints.

Health problems related to lack of sleep are also a special concern for the elderly. They add that insomnia has been associated with a risk of death from heart disease and other causes. And the risk of potentially devastating falling injuries is greater for sleep-deprived older people.

Behavioral interventions for sleep problems include the following groups of therapy:

Relaxation-based.

Behavior changes, such as sleep scheduling and sleep restriction therapy that limits sleep quantity in an effort to improve sleep quality.

Cognitive behavioral therapy, which examines lifestyle habits such as exercise and alcohol.

The studies Irwin reviewed involved more than 500 people (adults younger and older than age 55) with insomnia who got one or more of these treatments. All of the approaches were found to be useful for treating a variety of sleep complaints, including trouble falling asleep, frequent waking during the night, and poor sleep quality.

The findings are reported in the January 2006 issue of the journal Health Psychology.

Undertreatment Common

Few studies have compared behavioral treatments to drug therapy. Yet the amount of improvement seen with behavioral therapy is similar to studies of newer sleep medications, says Irwin.

The new sleep medications like Ambien, Sonata, and Lunesta are acknowledged to be safer and have fewer side effects than older sleeping pills. While most are approved for short-term use, they are increasingly being used long term in people with chronic insomnia.

Irwin says there are many unanswered questions about the safety and usefulness of these medications when used long term. But sleep specialist David Neubauer, MD, says the risk of abuse and addiction with the newer sleeping pills appears small.

Neubauer tells WebMD that just as there are many different causes of insomnia in elderly people, there are many potential approaches to treatment.

"Sleep problems are not an inherent part of the aging process, but they are more common in the elderly," he says. "Older people have a greater risk for depression and chronic medical disorders that can undermine sleep. They are also more likely to be taking medications, which can also interfere with sleep."

Managing chronic pain or other medical conditions may be all that is needed to restore normal sleep, he says.

But like younger people, many elderly people with sleep problems will need long-term treatment, which may involve behavioral therapies or a combination of behavioral treatments and sleeping pills. He adds that undertreatment of insomnia is especially common among the elderly.

"It is important to identify and treat insomnia in the elderly because it is a big quality-of-life issue," he says.

SOURCES: Irwin, M. Health Psychology, January 2006; online edition. Michael Irwin, MD, professor, Cousins Center for Psychoneuroimmunology, University of California at Los Angeles. David N. Neubauer, MD, associate director, Johns Hopkins Sleep Disorders Center, Baltimore.


Insomnia Can Trigger Depression, Study Shows
Treating Sleep Problems May Speed Recovery

By Salynn Boyles 
WebMD Medical News

Reviewed By Brunilda Nazario, MD
on Friday, June 24, 2005

June 24, 2005 -- Insomnia has long been thought of as a symptom of depression, but new research shows it may actually trigger the mental disorder.

In one study, depressed seniors with insomnia were 17 times more likely to remain depressed after a year than patients who were sleeping well. The findings were presented Tuesday at the 19th Annual Meeting of the Associated Professional Sleep Societies in Denver.

In a separate study, seniors with insomnia and no history of depression were six times more likely to experience an episode of depression as seniors without insomnia. The association was strong for women and for people who suffer from a particular insomnia pattern that awakens a person repeatedly during the night.

Both studies were conducted by researchers from the University of Rochester Sleep and Neurophysiology Research Laboratory. Lab director Michael Perlis, PhD, tells WebMD that while the research focused on seniors, the findings could apply to anyone with chronic insomnia.

"The assumption has been that if depression is well treated, the insomnia will go away, but this is not the case," Perlis tells WebMD. "It is increasingly clear that you can't ignore chronic insomnia [in patients with depression]. You have to treat it."

Other Research

In another study, researchers report that patients with depression and sleep problems treated with the antidepression drug Prozac and the insomnia drug Lunesta got better quicker than those treated for depression only.

Perlis and colleagues are also conducting depression studies to determine if treating insomnia reduces the severity or lengthens the time between episodes of depression.

They are also examining the impact of insomnia treatment on pain management in patients with chronic back pain. The research is being funded by a $2.3 million grant from the National Institutes of Health.

He says there is growing evidence linking chronic insomnia with other common ailments, including high blood pressure and type 2 diabetes. He defines chronic insomnia as a troubling a sleep disturbance lasting more than three months.

Treating Insomnia

So which treatments work best?

Perlis says that insomnia of a few days duration should be ignored as much as possible.

"If you don't compensate in any way by changing your habits, the ship is likely to right itself," he says. "But if you change your habits, by either sleeping later, going to bed earlier, or forcing yourself to stay in bed when you're wide awake, you are laying down the foundation for a more chronic disorder."

If the insomnia persists beyond five days or so, it should definitely not be ignored, Perlis says. He recommends trying one of the new generation of prescription hypnotic sleep drugs, such as Ambien, Sonata, or Lunesta, or trying behavioral therapy that specifically targets insomnia.

In a report issued last week, an expert panel convened by the National Institutes of Health endorsed the behavioral therapy approach. Panel members also expressed concern about the widespread use of over-the-counter and prescription medications that have no clear benefit in the treatment of insomnia, such as antidepressants and antihistamines.

While conceding that the new generation of insomnia drugs has fewer and less severe side effects than other sleep medications and shows promise for long-term use, the panel concluded that long-term safety has not been proven.

The experts noted that relaxation training combined with therapy targeting erroneous, anxiety-producing beliefs about sleep loss has been shown to be an effective treatment for insomnia.

"We know that patients can struggle for years with insomnia, and we know that they use a variety of over-the-counter and prescription drugs to deal with it," panel chairman Alan Leshner, PhD, says, in a news release. "Unfortunately, we found insufficient evidence to recommend most of these treatments for long-term use. There's a clear need for more research to fill this gap."

SOURCES: 19th Annual Meeting of the Associated Professional Sleep Societies, Denver, June 18-23, 2005. Michael Perlis, PhD, director, University of Rochester Sleep and Neurophysiology Research Laboratory. Krystal, A., presentation, APSS meeting. National Institutes of Health Panel Report on the Treatment of Chronic Insomnia, June 15, 2005. Alan Leshner, PhD, chief executive officer, American Association for the Advancement of Science; chairman, NIH panel on insomnia treatment.


What to Do About Insomnia
Can't Sleep? Insomnia Types, Causes, and Treatments

By Michael Breus, PhD, D, ABSM 
WebMD Feature

Reviewed By Stuart Meyers, MD

Just can't get to sleep? Can't stay asleep? Waking up too early? Not feeling refreshed and restored in the morning? Not functioning well during the day? You may have insomnia.

Up to about one-third of the population have symptoms of insomnia. Those with insomnia typically experience:

  • Sleepiness
  • Fatigue
  • Poor concentration
  • Decreased alertness and performance
  • Muscle aches
  • Depression during the day and night
  • An over-emotional state (tense, worried, irritable, and depressed)

While it may be very difficult to get to sleep at bedtime, you find yourself "out like a light" in front of the TV, at a movie, reading, or even driving. And anticipating getting a poor night's sleep as well as developing rituals and behaviors you think will help your sleep (going to bed earlier) may actually have the opposite effect -- and make the problem worse. Such is the plight, misery, and danger of insomnia.

Many of us experience temporary insomnia from a few days to a few weeks. This kind of insomnia usually results from normal events in our lives such as:

  • A stressful event
  • Emotional stress
  • Illness
  • Temporary pain
  • Disturbances in sleep hygiene (environmental factors under your control that may contribute to disturbed sleep and insomnia)
  • Disruptions to circadian rhythm (the 24-hour rhythmic regulation of our body processes)

When stressful situations resolve, when you recover from illness, when the pain goes away, when sleep hygiene improves -- then sleep usually improves.

Circadian rhythm disruptions like shift work and jet lag may contribute to insomnia because the times you fall asleep and wake up are temporarily shifted. Proper sleep hygiene, particularly the amount of and timing of light, can help re-set your circadian rhythm and improve the symptoms of insomnia from these causes.

Medical Causes

Insomnia also may result from a variety of medical conditions, pain, and even the treatments for these disorders. And poor sleep hygiene can make these medical conditions worse.

Depressive illnesses are almost always associated with sleep disturbances. Those suffering from anxiety may be unable to sleep due to intrusive thoughts, an inability to relax, obsessive worrying, and an "overactive" mind. Bipolar, panic, and psychiatric disorders are each associated with sleep disturbances as well.

Pain from arthritis, other rheumatologic diseases, cancer, and various neurological disorders, like neuropathy from diabetes are common causes of insomnia. Gastrointestinal disorders like acid reflux and stomach ulcers, as well as angina from heart disease may cause chest pain, and consequent awakenings during the night. In addition, cluster headaches may be precipitated during certain stages of sleep or occur from lack of sleep.

Treatment for these types of insomnia rests primarily with treating the underlying medical condition. These conditions, as with many others, interact with sleep in a complex manner, with each impacting the other. Exactly how all these factors interact is not completely known, but being aware of the sleep component allows us to target each aspect individually and achieve vastly improved interventions and treatments. So it is critical to understand and communicate to your doctor how your condition affects your sleep and that your sleep disturbances may exacerbate your medical condition. This will ensure that he/she may integrate your sleep problem into the overall treatment plan, and utilize a sleep specialist, if needed.

The "pins and needles," "internal itch," or "creeping, crawling sensation" of restless leg syndrome (RLS) also make it quite difficult to fall asleep, especially since those symptoms occur more often when one is sleepy or lying down and are relieved only by vigorously moving the legs. The symptoms of RLS may awaken one out of sleep, forcing the sufferer to walk around to relieve the discomfort.

Most people with RLS also have periodic limb movement disorder (PLMD), repetitive movements of the toe, foot, and sometimes knee and hip during sleep. These movements may cause arousals that lead to non-restorative sleep. Your doctor can prescribe various medications to reduce or eliminate the movements and the associated sleep disturbances (arousals) caused by these disorders. This results in a more sound sleep, one from which you awaken restored and refreshed.

Other illnesses that often have nighttime symptoms that cause awakenings include:

  • An enlarged prostate that frequently awakens men to urinate
  • Congestive heart failure and emphysema, which cause difficulty breathing
  • The immobility from paralysis or Parkinson's disease
  • Hyperthyroidism, stroke, and alcoholism

Another reason why communicating symptoms of insomnia to your doctor is so important is the possibility that the treatments for medical conditions themselves may cause or worsen insomnia. Following is a brief list of some classes of drugs that may fall into this category:

  • Antidepressants
  • Antihypertensives
  • Antiarrhythmics
  • Antibiotics
  • Antihistamines
  • Antivirals
  • Bronchodilators
  • Central nervous system stimulants
  • Corticosteroids
  • Decongestants
  • Diuretics
Non-steroidal anti-inflammatory drugs

Back to Sleep

Developing good sleep hygiene is very important for insomnia relief. For example, smoking, drinking, and exercise can affect your sleep dramatically. What you actually do in bed (like reading or watching TV), the temperature of room, noise levels, the timing and amount of fluids you drink, and the food you eat significantly impact insomnia. Exposure to light in the evening (looking at a bright computer screen, turning on the light to go to the bathroom) may alter your circadian rhythms. Poor hygiene alone can generate significant sleep problems.

Treatment for insomnia falls into two basic categories, medication and behavioral strategies for sleep initiation. Doctors tend to use one of three different types of medication for insomnia, including:

1.       The so-called non-benzodiazepine or "non-valium-like" hypnotics (such as Ambien and Sonata) are designed for insomnia and are often first-line treatment. They are especially effective because they work quickly, do not disrupt your "sleep architecture" or the quality of your sleep, and are not addictive.

2.       When considering underlying depression associated with insomnia, antidepressants are often used because of their sedating side effects.

3.       Hypnotics (including Restoril, Halcion, and Klonipin) should be used only in selected patients because they are potent medications that greatly impact the quality of sleep and may have severe side effects, including daytime drowsiness and addiction.

Behavioral strategies include:

  1. Sleep restriction, that is, restricting where one sleeps to only the bed. The idea here is that you sleep only in bed and you stay in bed only when asleep. Do not lie awake in bed for hours on end. If you do not fall asleep after about 25 minutes, get out of bed and do something calming, like read a book. This helps reduce the anxiety-provoking association of being awake while in bed, and ultimately may create the positive association of sleeping well in bed. When restricting sleep in this manner, you will eventually become so tired that you become sleepy earlier in the evening, relieving insomnia. Given how tired one will be when beginning this regimen, activities where safety is an issue, like driving, should be avoided.
  2. Stimulus control involves making the bedroom a place for sleep and sex only -- no TV-watching, for example. This again tries to create associations to help train your mind.
  3. Relaxation uses certain techniques to relax your mind and body, making it easier to fall asleep and stay asleep.
  4. Cognitive behavioral therapy. Here a psychologist helps to eliminate those thoughts associated with a poor night's sleep.

All the therapies noted above should be instituted, directed, and monitored by a doctor after a proper evaluation and diagnosis.

As if the misery of insomnia is not enough, chronic insomnia takes an additional toll. Studies show an increased mortality risk for those reporting less than either six or seven hours per night. One study found that reduced sleep time is a greater mortality risk than smoking, high blood pressure, and heart disease.

So, if you have symptoms of insomnia, it is very important take it as seriously as any other medical condition or illness. Establish good sleep hygiene and see your doctor or sleep specialist.

Originally published April 1, 2003. 
Medically updated September 2004.

SOURCE: Sleep Medicine, Kryger, Meir, et al., Third Edition, 2000. WebMD Medical Reference from Healthwise: " Insomnia ."


Short Insomnia Therapy Beats Sleeping Pills 
4 Half-Hour CBT Sessions Work Better, Last Longer Than Ambien

Reviewed By Brunilda Nazario, MD 
on Monday, September 27, 2004

Sept. 27, 2004 -- Need help getting to sleep? Four half-hour therapy sessions work better than sleeping pills, a new study shows.

It's called cognitive behavioral therapy or CBT. CBT helps people recognize, challenge, and change unhelpful thoughts and behaviors. But can this really work better than modern sleeping pills?

Yes, finds Gregg D. Jacobs, PhD, a psychologist at the sleep disorders clinic of Beth Israel Deaconess Medical Center and assistant professor of psychiatry at Harvard Medical School in Boston.

"If someone has insomnia, [he or she doesn't] have to live with it. An effective treatment exists," Jacobs tells WebMD. "It is not a drug, but CBT. It works better than sleeping pills in the short term and in the long term -- and has no side effects."

Jacobs and colleagues report their findings in the Sept. 27 issue of Archives of Internal Medicine.

CBT isn't a new treatment. It's already the mainstay of therapy for most sleep specialists, says Richard Simon Jr., MD, medical director of the Katheryn Severyns Dement sleep disorder center in Walla Walla, Wash.

"My experience says this is right on the money," Simon tells WebMD. "As a sleep specialist I do it and I get very, very good results. No sleep specialist would disagree that CBT is the mainstay of therapy. This study clearly indicates robust effects."

Head-to-Head: CBT vs. Ambien vs. Combination

What makes Jacobs so excited are the results of a study with 63 insomnia sufferers recruited via newspaper ads. The patients were randomly assigned to one of four treatments: CBT, Ambien, CBT plus Ambien, or a placebo pill.

CBT consisted of four, 30-minute sessions (once weekly for three weeks, then a final session two weeks later) plus a 15-minute follow-up phone call.

Why Ambien and not some other sleeping pill?

"We picked Ambien because it is one of two approved newer-generation sleeping pills -- the other is Sonata -- that work selectively in brain and have reduced side effects," Jacobs says. " Ambien, from our perspective, is the best choice on the market if you have sleep onset problems, because it works as well as others without as many side effects."

It may be the best sleeping pill for people who have trouble getting to sleep. But it doesn't work nearly as well as CBT, Jacobs and colleagues found. Insomnia sufferers got to sleep faster and more efficiently after CBT than after taking Ambien. In fact, nearly 60% of the CBT-treated patients got to sleep just as fast as people without insomnia do -- in 30 minutes or less.

"These results are extremely impressive," Jacobs says. "When you take people who have long-standing insomnia -- who every night need more than an hour to fall asleep -- and say 60% get to normal sleep, that is outstanding data."

CBT-treated patients who didn't achieve normal sleep patterns still got to sleep much faster they did before treatment.

"For many of them, instead of taking an hour and a half, they are sleeping in 45 minutes," Jacobs says. "They increase their sleep time and reduce their waking time. That, to them, is a major success."

One might think that giving patients Ambien plus CBT would work better. But the combination wasn't any better than CBT alone. That's a surprise, says Simon.

"If a person comes in with chronic insomnia, it takes a while for CBT to have an impact," Simon says. "So we often give a sleeping pill for the first few weeks. But the Jacobs study shows that the combination does not seem to add much. That is an interesting finding."

CBT: Long-Lasting Effect

The debate over the relative efficacy of sleeping pills versus CBT has smoldered for a long time, notes sleep researcher Milton Kramer, MD, director of psychiatric research at Maimonides Medical Center, New York, and clinical professor of psychiatry at New York University.

"The core issue relates to effectiveness over time," Kramer tells WebMD. "A lot of studies show CBT can be effective, and a year after treatment patients still have made gains. With sleep medications, there's always been a question of effectiveness when treatment ends."

CBT's long-lasting effect gives it an advantage over sleeping pills, says sleep expert Max Hirskowitz, PhD, associate professor of medicine and psychiatry at Baylor College of Medicine, Houston.

"If we treat you with Ambien you will sleep, but when we stop treating, you are likely to go back to not being able to sleep. CBT gives tools with which people can help themselves in the longer run. With CBT, the benefits endure," Hirskowitz tells WebMD.

But there are drawbacks.

"The disadvantage to CBT is that it is not widely available. In many locations, it is difficult to find a practitioner who knows how to do it properly," Hirskowitz says. "And it is time consuming."

That's just what Jacobs is trying to get around. He notes that his team gets results with just four half-hour sessions -- less than the six to eight CBT sessions common for other psychiatric treatments. True, he says, doctors and psychologists need training before they can treat insomnia with CBT. But not everyone with insomnia needs a top-notch CBT therapist.

"Whether a person will benefit from simple guidelines or in-depth CBT depends on the patient," Jacobs says. "Some can go on WebMD and see this article, or reference my book, Say Goodnight to Insomnia, and that is all they need. This is not something you necessarily have to find at a sleep clinic."

Elements of CBT for Insomnia

As its name implies, CBT has two parts: cognitive and behavioral.

The cognitive portion of CBT requires people with insomnia to recognize, challenge, and change the ways of thinking that keep them from falling asleep.

"It involves educating insomnia patients about the fact they often engage in distorted, stress-inducing behavior about insomnia," Jacobs says. "We place an emphasis on their worries and anxieties about how their insomnia will affect their next-day performance and long-term health. We educate them about research showing that in most cases their concerns are not accurate."

CBT therapists provide information to counter negative thoughts relating to their problem.

People with insomnia also have distorted ideas about how well they actually sleep.

"Insomnia patients say, 'I never slept at all last night,' or, 'It took me until 4 a.m. to fall asleep,'" Jacobs notes. "But if you measure their sleep, you see they slept for four or five hours. In therapy sessions, they learn their perceptions of sleep are not quite accurate. And in these sessions we role play a little bit to give them replacement sleep thoughts."

The second part of CBT is behavior. This is what many sleep experts call "sleep hygiene."

The most important rule, according to Jacobs and Simon: Get out of bed if you can't sleep. Go to another room and do something that makes you drowsy.

"The most important thing is restricting time in bed so it most closely matches sleep time," Jacobs says. "People with sleep-onset insomnia average five hours of sleep -- but eight hours in bed. There is a huge mismatch between their actual sleep time and their time in bed. It actually inhibits their sleep drive. If they are out of bed, they build up more sleep drive and sleep better at night."

Here are Simon's other rules for sleep hygiene:

  • Get up at the same time every day. Wake up by the clock. That should be within one or two hours of the same time, workdays as well as on weekends.
  • Get as much light as you can during your desired waking hours. The biological clock is reset when you are exposed to bright light and we want as little light as possible during sleep hours.
  • Go to bed at night only when you think you can fall asleep. Wake by the clock, but go to bed when your body tells you to.
  • If you are having trouble sleeping, minimize naps during the day. Patients with insomnia often take naps. We tell them not to.
  • Minimize drugs that disturb sleep. Caffeine has to be minimized. Minimize nicotine and alcohol, particularly in the hours before bedtime.
  • Exercise regularly. The best time is early morning to midday. Try not to exercise within five to six hours of bedtime.
  • It takes about an hour or so to unwind before going to sleep. So shut off the day an hour or two before bedtime. Stop watching news shows. If you need to, write down your daily worries in a journal and close it. Then take warm bath. Drink some warm milk with honey.
  • Make your bedroom your sanctuary. This is where you get to enjoy eight hours a night of refreshing sleep.

SOURCES: Jacobs, G.D. Archives of Internal Medicine, Sept. 27, 2004; vol 164: pp 1888-1896. Gregg D. Jacobs, PhD, sleep disorders clinic, Beth Israel Deaconess Medical Center; and assistant professor of psychiatry, Harvard Medical School, Boston. Richard Simon Jr., MD, medical director, Katheryn Severyns Dement sleep disorder center, Walla Walla, Wash. Milton Kramer, MD, director of psychiatric research, Maimonides Medical Center, New York; and clinical professor of psychiatry, New York University. Max Hirskowitz, PhD, associate professor of medicine and psychiatry, Baylor College of Medicine, Houston.

 

NIH State-of-the-Science Conference Statement on Manifestations 
and Management of Chronic Insomnia in Adults

National Institutes of Health
State-of-the-Science Conference Statement
June 13-15, 2005

FINAL STATEMENT 
August 18, 2005

NIH Consensus and State-of-the-Science statements are prepared by independent panels of health professionals and public representatives on the basis of (1) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality (AHRQ), (2) presentations by investigators working in areas relevant to the conference questions during a 2-day public session, (3) questions and statements from conference attendees during open discussion periods that are part of the public session, and (4) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government.

The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research.

Introduction

Insomnia is the most common sleep complaint across all stages of adulthood, and for millions, the problem is chronic. Insomnia often is comorbid with other disorders, particularly depression, as well as some cardiovascular, pulmonary, and gastrointestinal disorders. In the absence of comorbid conditions, insomnia is thought to be a primary disorder in itself. Whether it is the primary disorder or secondary to some other condition, chronic insomnia is often associated with a wide range of adverse conditions, including mood disturbances, difficulties with concentration, and memory. Whether insomnia is the cause or result of associated problems is not always easily determined, but is critical to treatment strategies for individual patients.

A variety of behavioral and pharmacological approaches show promise for managing chronic insomnia symptoms. However, there has been limited guidance for clinicians in choosing the best treatment for chronic insomnia due to the paucity of randomized clinical trials (RCTs) for many widely used treatments. Available treatments include an array of behavioral or nonpharmacologic interventions; hypnotic medications; and antidepressant, antipsychotic, or antihistamine medications.

As pointed out in the recent 2003 National Sleep Disorders Research Plan, published by the National Center on Sleep Disorders Research at the National Institutes of Health (NIH), there is great need for additional research to better define the nature of chronic insomnia and ways to characterize its detailed expression in diverse patients. Additional systematic research is also greatly needed to provide a more thorough database from which clinicians and patients can make more informed choices about treatment options.

To address these needs, the National Institute of Mental Health and the Office of Medical Applications of Research of the NIH sponsored a State-of-the-Science Conference on the Manifestations and Management of Chronic Insomnia in Adults on June 13–15, 2005, in Bethesda, MD. During the first 2 days of the conference, experts presented the latest scientific knowledge about chronic insomnia and available treatments. After weighing all of the scientific evidence, an independent panel prepared and presented the following state-of-the-science statement. The panel was charged with answering five specific questions:

  1. How is chronic insomnia defined, diagnosed, and classified, and what is known about its etiology?
  2. What are the prevalence, natural history, incidence, and risk factors for chronic insomnia?
  3. What are the consequences, morbidities, comorbidities, and public health burden associated with chronic insomnia?
  4. What treatments are used for the management of chronic insomnia, and what is the evidence regarding their safety, efficacy, and effectiveness?
  5. What are important future directions for insomnia-related research?

The conference was intended for health care professionals, researchers, patients and their families, and members of the public interested in the nature of and available treatments for chronic insomnia. The conference included formal expert presentations focusing on the individual conference questions and oral and written input from professionals and members of the lay public. In addition, the independent panel benefited greatly from a comprehensive systematic literature review, prepared by the University of Alberta Evidence-based Practice Center.

1. How is chronic insomnia defined, diagnosed, and classified, and what is known about its etiology?

Definition

Insomnia may be defined as complaints of disturbed sleep in the presence of adequate opportunity and circumstance for sleep. The disturbance may consist of one or more of three features: (1) difficulty in initiating sleep; (2) difficulty in maintaining sleep; or (3) waking up too early. A fourth characteristic, nonrestorative or poor-quality sleep, has frequently been included in the definition, although there is controversy as to whether individuals with this complaint share similar pathophysiologic mechanisms with the others.

Chronic insomnia should be distinguished from acute insomnia, which may occur in anyone at one time or another (e.g., the night before an important event the next day). While some papers have utilized 6-month duration of the above symptoms to define chronicity, there is evidence to suggest that as few as 30 days of symptoms are clinically important. Accordingly, for the purposes of literature review, we have defined chronic insomnia as 30 days or more of the symptoms described above.

The importance of sleep disruption often rests with its impact on the individual’s daytime function. Guidelines incorporating impact on function along with the above features in the definition of insomnia have recently been published in an effort to standardize future insomnia research. However, the impact of sleep disruption goes beyond the insomniac. When children and the elderly (particularly nursing home residents) suffer from insomnia, parents and caregivers also suffer. Employers of those with insomnia suffer when their work performance is affected. Daytime drowsiness may make insomniacs dangerous as drivers.

Most cases of insomnia are comorbid with other conditions. Historically, this has been termed “secondary insomnia.” However, the limited understanding of mechanistic pathways in chronic insomnia precludes drawing firm conclusions about the nature of these associations or the direction of causality. Furthermore, there is concern that the term “secondary insomnia” may promote undertreatment. Therefore, we propose that the term “comorbid insomnia” may be more appropriate. Common comorbidities include psychiatric disorders, particularly depression and substance use disorders; cardiopulmonary disorders; and conditions associated with chronic somatic complaints (i.e., musculoskeletal syndromes such as rheumatoid arthritis or lower back pain) that may disrupt sleep. Other associated sleep disorders can also contribute to insomnia, particularly obstructive sleep apnea, restless legs syndrome, or periodic limb movement disorder. “Primary insomnia” is the term used when no co-existing disorder has been identified.

Diagnosis

Diagnosis is based primarily on patient-derived and family or caregiver complaints, as determined by the clinical interview. However, there has been little research to show how accurately persons reporting sleep problems can judge their own sleep latency or periods of wakefulness during the night. Medical history and physical examination are useful in establishing the presence of comorbid syndromes.

Other tools have been used as an aid to diagnosis, although many are limited in their validation. Sleep diaries can help to document sleep/wake cycles. Various questionnaires have been formulated, but there is a lack of standardization. An actigraph, a wrist-worn device that measures movement to infer sleep and wake cycles, is employed in the evaluation of circadian rhythm disorders, but its use in insomnia has not been fully validated. Multichannel polysomnography, either in-lab or at home, is the most sensitive tool to differentiate wakefulness and sleep. However, polysomnography is expensive and because the numerous monitoring electrodes can actually disrupt sleep, its use as a diagnostic tool for insomnia should be limited to cases in which other sleep disorders, such as sleep apnea, are suspected.

Classification and Etiology

Insomnia has been classified either based on its specific symptoms (i.e., sleep onset or sleep maintenance) or the duration of the disorder. Etiology-based classification schemes also have been advocated. Evidence supports both psychological and physiological models in the etiology of insomnia. Psychological models include the concepts of conditioning, hyperarousal, stress response, predisposing personality traits, and attitudes and beliefs about sleep. Physiological models have been explored in animals in an effort to identify neural systems that regulate arousal and sleep. The precise relationship between physical illness and changes in brain function that result in insomnia remains uncertain.

2. What are the prevalence, natural history, incidence, and risk factors for chronic insomnia?

Prevalence

Although chronic insomnia is known to be common, studies of its prevalence have yielded variable estimates (i.e., the proportion of persons who have the disorder at a given point in time). Evidence from epidemiologic studies varies depending on the definition of chronic insomnia and the diagnostic and screening methods used. Population-based studies suggest that about 30 percent of the general population complains of sleep disruption, while approximately 10 percent has associated symptoms of daytime functional impairment consistent with the diagnosis of insomnia, though it is unclear what proportion of that 10 percent suffers from chronic insomnia. Not surprisingly, higher prevalence rates are found in clinical practices, where about one-half of respondents report symptoms of sleep disruption.

Natural History

Few studies have described the course or duration of insomnia. Unpublished data from a middle-aged population followed over 10 years describe a persistence of symptoms. The limited prospective data on patients with sleep complaints of at least a month’s duration showed that in the majority of insomniacs, symptoms are of long duration. The paucity of literature describing the natural course of insomnia underscores the need for large-scale longitudinal studies.

Incidence

Very little is known about chronic insomnia’s incidence, which is the number of new cases of the disorder arising in a specific time period, such as a year. Because prevalence may be affected by events occurring after the insomnia is under way, incident cases give the best information about the causes of insomnia’s occurrence. Unfortunately, only a few studies have investigated the incidence of chronic insomnia or the circumstances under which it first appears. Increasing the number of studies of the incidence of chronic insomnia is a clear research priority.

Duration

Research on the duration of chronic insomnia is also needed. The disorder can last for relatively short periods of time in some patients and for decades in others. Insomnia can also recur after a period of remission. When studies of chronic insomnia incidence are conducted, the newly ascertained cases can be followed longitudinally to describe the disorder’s natural history. In these studies, it will be possible to investigate factors that are suspected of affecting chronic insomnia’s duration, remissions, and relapses. It will be particularly important to determine which therapies the treated patients receive and their success in relieving symptoms or preventing relapses.

Risk Factors

Several problems limit the ability to compare and integrate available information from existing observational studies on correlates of insomnia: (1) validated diagnostic instruments have not been applied in large, population-based studies; (2) the many comorbid physical and psychiatric conditions associated with a diagnosis of insomnia may be its cause, its consequence, or share its risk factors. Because most studies have been cross-sectional observations of affected persons rather than prospective studies of persons beginning prior to the onset of insomnia, decisions cannot be made as to which of its correlates are actually causal.

Many studies have found greater prevalence of insomnia among older people, perhaps as a consequence of declining health and/or institutionalization. Whether rates of insomnia increase with age in healthy older people remains unclear. Most observational studies of insomnia have found greater prevalence among women, especially in the postmenopausal years. Current evidence on differences among racial or ethnic groups in prevalence of insomnia within the United States is limited and inconclusive.

Several studies have found higher prevalence of insomnia in divorced, separated, and widowed adults than in married adults. In some studies, lower education and income have been associated with a higher prevalence of insomnia.

Several psychiatric and physical illnesses have strong relationships with insomnia. Insomnia is a symptom of depression, so it is not surprising that a diagnosis of depression is associated with insomnia. Other medical conditions, including arthritis, heart failure, pulmonary and gastrointestinal disorders, Parkinson’s disease, stroke, and incontinence, also affect sleep and increase the prevalence of insomnia. The extent to which treatment for these conditions ameliorates insomnia remains unclear.

Cigarette smoking, alcohol and coffee consumption, and consumption of certain prescription drugs also affect sleep and are associated with increased prevalence of insomnia. Although modification of these behaviors might be expected to reduce the prevalence of insomnia, studies have yet to demonstrate the effectiveness of these lifestyle changes as treatment for insomnia.

Future Studies

Validated instruments with known psychometric properties are needed, with attention paid to ease of administration, cross-cultural applicability, and comparability to objective measures of sleep performance, both overall and within important subgroups. Attention is also needed concerning the reliable measurement of the degree of sleep disturbance and the severity of symptoms of insomnia.

Another hypothesis relates to the possible genetic etiology of insomnia. Work is needed to quantify the importance of family history, along with a systematic search for specific genes.

Correlates of insomnia should be explored for their relationships with the development of subsequent insomnia. For example, studies are needed of the impact on incidence of insomnia of divorce, separation and bereavement, polypharmacy, and major chronic diseases.

Longitudinal observational studies are needed to identify factors affecting incidence of and remission from insomnia. An efficient approach would be to add validated questions on chronic insomnia to ongoing observational studies to assess the many potential determinants of insomnia incidence, persistence, and remission.

3. What are the consequences, morbidities, comorbidities, and public health burden associated with chronic insomnia?

Consequences, Morbidities, and Comorbidities

Insomnia appears to be associated with high health care utilization. The direct and indirect costs of chronic insomnia have been estimated at tens of billions of dollars annually. However, these estimates depend on many assumptions. In estimating the economic consequences of insomnia, it is difficult to separate the effects of insomnia from the effects of comorbid conditions. For example, a person with joint pain who has problems sleeping may seek health care for the arthritis rather than for sleep problems, assuming that the pain accounts for the sleep difficulty.

Only a few studies have examined the effects of insomnia on functioning in everyday life. These studies suggest that insomnia reduces quality of life and hinders social functioning. Two studies have identified a relationship between chronic insomnia and work days missed. Other studies indicate that insomnia is related to impaired work performance. There is at least some evidence of a relationship between chronic insomnia and impaired memory and cognitive functioning.

Laboratory studies indicate that sleep loss results in impaired psychomotor and cognitive functioning. There is evidence that chronic insomnia or the drugs used to treat it contribute to the increased number of falls in older adults.

Insomnia usually appears in the presence of at least one other disorder. Particularly common comorbidities are major depression, generalized anxiety, substance abuse, attention deficit/hyperactivity in children, dementia, and a variety of physical problems. The research diagnostic criteria for insomnia recently developed by the American Academy of Sleep Medicine indeed share many of the criteria of major depressive disorder. Studies to explain these overlaps require determining how often insomnia precedes the disorders with which it is associated and whether it continues to exist if the other disorders go into remission.

Both insomnia and its treatment may adversely affect quality of life. Treatment studies should include measures of undesirable side effects as well as the reduction of symptoms of insomnia. Costs of illness and of treatment should be assessed to allow for an analysis of the cost-effectiveness of treatments. The U.S. Department of Health and Human Services has developed useful guidelines for these assessments, and these should be consulted in the development of evaluation protocols. In addition to measures of sleep symptoms, effects on quality of life should also be measured.

Public Health Burden

The focus of public health is on populations rather than on individuals. The public health consequences of insomnia are difficult to evaluate because the literature is not well developed at this time. Sleep research has focused on basic mechanisms and clinical studies. Relatively little attention has been paid to the public health burden of insomnia. To better understand the public health consequences of insomnia, several lines of research should be considered.

The association of insomnia with premature death has not been studied. Separating the effects of insomnia from the effects of its comorbidities will be a methodological challenge. A start has been made by adding measures of sleep to the National Health and Nutrition Examination Survey; such measures should be added to other major epidemiological studies, including the Behavioral Risk Factor Surveillance Survey.

The effect of insomnia on quality of life has been reported in few studies. Secondary analysis of data from major population studies that include both measures of sleep and measures of functioning and quality of life should be supported. New studies are needed to determine whether insomnia causes job-related disability. Furthermore, we need to support additional studies to determine whether treatment for insomnia affects job performance and academic performance.

The economic consequences of insomnia are not clearly understood. New studies are needed to estimate the direct and indirect costs of chronic insomnia and the potential societal benefits that might accrue from successful intervention programs. Finally, insomnia has effects beyond individual patients. Families, caregivers, and friends of the sufferers are also affected. More evidence is needed to document these effects.

4. What treatments are used for the management of chronic insomnia, and what is the evidence regarding their safety, efficacy, and effectiveness?

Epidemiological surveys have shown that the most common treatments used by people with chronic insomnia are over-the-counter (OTC) antihistamines, alcohol, and prescription medications. The major forms of psychological treatments that have been systematically evaluated are the cognitive and behavioral therapies. Alternative and complementary treatments include melatonin and herbal remedies, such as valerian.

Assessment of the efficacy of treatments for chronic insomnia is complicated by a number of factors. Studies said to have been carried out on subjects with insomnia often lack consistency in the criteria used to diagnose chronic insomnia, a history of the duration and severity of the insomnia, or agreement on what effects of the treatment are to be evaluated. Further complicating the ability to assess treatments for chronic insomnia is its overlap with many medical and psychiatric conditions, most notably depression. Although there have been RCTs for several treatments, there is inconsistency in applying rigorous methodology to the assessment of a number of currently used treatments. Additionally, most clinical trials are relatively short term. There is a paucity of information about the long-term effects on sleep, daytime functioning, and quality of life.

Behavioral and Cognitive Therapies

Behavioral and cognitive-behavioral therapies (CBTs) have demonstrated efficacy in moderate to high-quality RCTs. Behavioral methods, which include relaxation training, stimulus control, and sleep restriction, were developed and first tested in the 1970s. More recently, cognitive therapy methods have been added to behavioral methods. Cognitive therapy methods include cognitive restructuring, in which anxiety-producing beliefs and erroneous beliefs about sleep and sleep loss are specifically targeted. When these cognitive methods have been added to the behavioral methods to compose a CBT package, it has been found to be as effective as prescription medications are for short-term treatment of chronic insomnia. Moreover, there are indications that the beneficial effects of CBT, in contrast to those produced by medications, may last well beyond the termination of active treatment. There is no evidence that such treatment produces adverse effects, but thus far, there has been little, if any, study of this possibility.

It is likely that most CBT is currently delivered by mental health practitioners or physicians with formal sleep medicine training. However, CBT refers to a number of varied nonpharmacologic treatments for insomnia, and a standardized “best practice” model has yet to be formulated and validated. Thus, future research should explore the optimum number and duration of sessions to yield positive results, particularly as delivered in busy primary care practices where the need and impact may be greatest.

Prescription Medications

Prescription medication therapy is intended to relieve symptoms of chronic insomnia only while the medication is being taken. Given this expectation, little or no research has been conducted on persistence or reappearance of symptoms after prescription medication therapy is discontinued.

This section describes the use of two categories of medications, the benzodiazepine receptor agonists that have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia and those that the FDA has approved for the treatment of other disorders but which doctors often prescribe to treat insomnia. The latter category is considered “off-label” usage. There are currently eight medications approved by the FDA for treatment of insomnia. Despite the fact that insomnia is often a chronic condition, only one of these medications (eszopiclone) has been approved for use without a specified time limit. The other medications have approved use limited to 35 days or less.

Benzodiazepine Receptor Agonists

Benzodiazepine receptor agonists fall into two broad groups of prescription hypnotics: benzodiazepines (estazolam, flurazepam, quazepam, temazepam, and triazolam) and the more recently introduced agents that act at benzodiazepine receptors but have a nonbenzodiazepine structure (e.g., zaleplon, zolpidem, and eszopiclone). Results from moderate to high-quality RCTs indicate that these eight agents are effective in the short-term management of insomnia. With the exception of eszopiclone, the benefits of these agents for long-term use have not been studied using RCTs. A recent clinical trial of eszopiclone provided evidence of sustained efficacy for 6 months in the treatment of subjects meeting DSM-IV criteria for primary insomnia.

Adverse effects associated with these medications include residual daytime sedation, cognitive impairment, motor incoordination, dependence, and rebound insomnia. These problems appear to be worse in the elderly. The frequency and severity of the adverse effects are much lower for the newer benzodiazepine receptor agonists, most likely because these agents have shorter half-lives. The available literature suggests that, in the short term, abuse of the benzodiazepine receptor agonists is not a major problem, but problems associated with their long-term use require further study in the general population of insomniacs.

Prescription Drugs Used Without FDA Approval for Insomnia

Antidepressants. Over the past 20 years, there has been a significant change in the use of prescription medications to treat chronic insomnia, with a decrease in the use of benzodiazepine receptor agonists and a substantial increase in the use of antidepressants. Based on recent surveys, the antidepressant trazodone is now the most commonly prescribed medication for the treatment of insomnia in the United States. In short-term use, trazodone is sedating and improves several sleep parameters. These initial effects are known to last for up to 2 weeks. Importantly, there are no studies of long-term use of trazodone for treatment of chronic insomnia. Another antidepressant, doxepin, has been found to have beneficial effects on sleep for up to 4 weeks for individuals with insomnia. Data on other antidepressants (e.g., amitriptyline and mirtazepine) in individuals with chronic insomnia are lacking. All antidepressants have potentially significant adverse effects, raising concerns about the risk–benefit ratio. There is a need to establish dose-response relationships for all of these agents and communicate them to prescribers.

Other Prescription Medications. A number of other sedating medications have been used in the treatment of insomnia. These include barbiturates (e.g., phenobarbital) and antipsychotics (e.g., quetiapine and olanzepine). Studies demonstrating the usefulness of these medications for either short- or long-term management of insomnia are lacking. Furthermore, all of these agents have significant risks. Thus, their use in the treatment of chronic insomnia cannot be recommended.

Nonprescription Medications (Over-the-Counter)

Antihistamines (H1 receptor antagonists such as diphenhydramine) are the most commonly used OTC treatments for chronic insomnia, but there is no systematic evidence for efficacy and there are significant concerns about risks of these medications. Adverse effects include residual daytime sedation, diminished cognitive function, and delirium, the latter being of particular concern in the elderly. Other adverse effects include dry mouth, blurred vision, urinary retention, constipation, and risk of increased intraocular pressure in individuals with narrow angle glaucoma.

Alcohol

Many insomniacs take an alcoholic drink before bedtime in order to reduce sleep latency. While alcohol does reduce sleep latency, drinking large amounts has been shown to result in poorer quality of sleep and awakening during the night. It is not known whether any impairment of sleep quality occurs when small amounts are used at bedtime. The risk of excess alcohol consumption in persons with alcohol problems makes this an inappropriate treatment for them.

Melatonin

Melatonin is a natural hormone produced by the pineal gland that plays a role in the control of circadian rhythms. Because melatonin is not regulated by the FDA, preparations containing it vary in strength, making comparisons across studies difficult. Although melatonin appears to be effective for the treatment of circadian rhythm disorders (e.g., jet-lag), little evidence exists for efficacy in the treatment of insomnia or its appropriate dosage. In short-term use, melatonin is thought to be safe, but there is no information about the safety of long-term use.

Valerian

Valerian is derived from the root of the plant species valeriana and is thought to promote sleep. Limited evidence shows no benefit compared with placebo. The FDA does not regulate valerian, and thus different preparations vary in valerian content. Safety data are minimal, but there have been case reports of hepatotoxicity in persons taking herbal products containing valerian. Other herbal remedies have also been promoted, but efficacy evidence is lacking.

L-tryptophan

L-tryptophan is an endogenous amino acid that has been used as a hypnotic. Systematic evidence supporting its use in the treatment of insomnia is extremely limited and based on studies with small numbers of subjects. Concerns are also raised about its possible toxic effects, particularly when used in combination with certain psychiatric medications.

Other Treatments

There are a number of alternative activities, including tai chi, yoga, acupuncture, and light therapy, that may be useful in the treatment of insomnia. These treatments have not been adequately evaluated at this time.

Research Recommendations

CBT and benzodiazepine receptor agonists have demonstrated efficacy in the acute management of chronic insomnia. However, full evaluation of the effectiveness of these therapies for chronic insomnia will require trials of longer duration that measure health outcomes—including the ability of treatments to ameliorate the daytime impairment related to sleep difficulty—and also integrate the risks and benefits of treatment.

Other therapies have also demonstrated some promise. However, little is known about the comparative benefits of these treatments, their generalizability, and their effects on understudied features of chronic insomnia.

In order to address this lack of knowledge, RCTs will be required that:

  • Are large-scale and multisite.

     

  • Compare at least two effective or promising treatments so that the comparative benefits of effective treatments can be evaluated. This should include comparisons among pharmacological agents, CBT, and combined treatment.
  • Evaluate the positive and adverse effects of treatments over longer timeframes, including the period after discontinuation of treatment.
  • Incorporate objective and subjective measures of daytime function and quality of life in addition to the traditional parameters of sleep, such as sleep onset latency and total sleep time.
  • Systematically evaluate a variety of commonly used OTC and alternative remedies for insomnia that have not been formally evaluated.
  • Measure the costs and cost-effectiveness of treatments.

The pharmaceutical industry is called upon to support comparisons of its medications not only with placebo but also with other effective treatments, including CBT.

Studies should be directed to important population subgroups, including children, nursing home residents, postmenopausal women, those with primary chronic insomnia, and those with insomnia comorbid with other conditions.

To overcome reporting bias in clinical trials, in which positive results are published while negative results are not, the development of a central registry for all insomnia trials is recommended. This registry would allow a systematic synthesis of the available clinical trial data.

As data from RCTs showing efficacy become available, it will be critical to evaluate effectiveness in broader clinical populations in community settings.

RCT study subjects for whom the tested substance appeared to be effective need to be followed over time, with random assignment to varying times at which the drug will be discontinued. These studies will give evidence for the appearance of side effects with long-term use, for the development of tolerance to the drug in time, and for any lasting beneficial effects after discontinuation of the drug.

Repeated surveys of physician prescribing behavior and decision making are recommended to permit an understanding of how their treatment behavior changes as new data on efficacy of insomnia treatments become available. Such studies will show whether substantial re-education programs for physicians should be supported.

5. What are important future directions for insomnia-related research?

Validated instruments are needed to assess chronic insomnia, with attention paid to the ease of administration and cross-cultural applicability. A greater range of outcome measures related to chronic insomnia and its consequences is also needed. Measures of sleep should be added to longitudinal epidemiologic studies that are collecting data on a broad range of items that could turn out to be risk factors for insomnia.

Studies are needed of the possible genetic etiology of chronic insomnia. The neural mechanisms underlying chronic insomnia are poorly understood. Studies aiming to identify neural mechanisms should use animal models and in vivo neural imaging approaches in people with insomnia and in individuals with normal sleep. Work is needed to quantify the importance of family history, along with a systematic search for specific genes.

Longitudinal observational studies are needed to identify factors affecting incidence of, natural history of, and remission from chronic insomnia. An efficient approach would be to add questions about chronic insomnia to ongoing observational studies that assess the many potential determinants of insomnia incidence, persistence, and remission.

The effects of insomnia on quality of life have been reported in few studies. Analyses of data from major population studies that include measures of sleep, measures of functioning, and quality of life should be supported. Studies are needed to determine whether insomnia causes job-related disability and whether treatment for insomnia enhances job performance and academic performance.

Studies are needed to estimate the direct and indirect societal costs of insomnia and the potential societal benefits that might accrue from successful intervention programs. Moreover, because chronic insomnia has effects that go beyond individual patients, more research is needed to quantify effects on families, friends, and caregivers of insomniacs.

CBT and benzodiazepine receptor agonists have been shown to be beneficial in the acute management of chronic insomnia. Other therapies have also demonstrated some promise. However, little is known about the comparative benefits of these treatments, their combination, and their effects on understudied features of chronic insomnia. To address this lack of knowledge, RCTs will be required that are large scale and multisite and compare at least two effective or promising treatments. This should include comparisons between pharmacological agents as well as between those agents and CBT. The pharmaceutical industry is called upon to compare its medications not only with placebo but also with other effective treatments, including CBT. Trials should include measures of cost and cost-effectiveness.

To overcome potential problems with reporting bias in clinical trials, the development of a central registry for all clinical trials is recommended. This registry would allow a systematic synthesis of the available clinical trial data.

As comparative efficacy data become available, it will be critical to conduct effectiveness studies to determine generalizability to broader clinical populations in community settings.

Studies should be directed to important population subgroups, including children, nursing home residents, postmenopausal women, those with primary chronic insomnia, and those with insomnia comorbid with other conditions.

Conclusions

Chronic insomnia is a major public health problem affecting millions of individuals, along with their families and communities. Little is known about the mechanisms, causes, clinical course, comorbidities, and consequences of chronic insomnia. Evidence supports the efficacy of cognitive-behavioral therapy and benzodiazepine receptor agonists in the treatment of this disorder, at least in the short term. Very little evidence supports the efficacy of other treatments, despite their widespread use. Moreover, even for those treatments that have been systematically evaluated, the panel is concerned about the mismatch between the potential lifelong nature of this illness and the longest clinical trials, which have lasted 1 year or less. A substantial public and private research effort is warranted, including developing research tools and conducting longitudinal studies of randomized clinical trials. Finally, there is a major need for educational programs directed at physicians, health care providers, and the public.


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