Chronic insomnia medicines have not yet been rigorously evaluated for long-term use

Many of the medications widely used to manage chronic insomnia have not yet been rigorously evaluated for long-term use, according to an independent scientific panel convened this week by the National Institutes of Health.

This is a critical consideration because for many patients, insomnia can persist for decades. The panel also stressed that many chronic insomnia sufferers could benefit from currently underused behavioral and cognitive therapies.

The panel was concerned that many of the drugs now used to treat insomnia, such as antidepressants and antihistamines, have not been approved for this indication; their efficacy in treating chronic insomnia has not been proven. Even those medications that have been approved for insomnia are approved only for short-term use, leaving chronic sufferers with few proven options. The panel noted that newer benzodiazepine receptor agonist medications have been developed that have fewer and less severe adverse effects than other medications, and show promise for long-term use, but this requires further evaluation. The panel also expressed concern that many insomnia sufferers self-medicate with alcohol, despite the numerous risks involved and the clear evidence that alcohol actually has a negative overall effect on the quality of sleep.

Research indicates that behavioral methods such as relaxation training can be effective to treat insomnia when combined with cognitive therapies specifically targeted at anxiety-producing beliefs and erroneous beliefs about sleep and sleep loss. Moreover, this approach is unlikely to carry adverse side effects, and its benefits may be longer lasting than pharmacological interventions. There are few practitioners trained in these therapies, however.

Alan Leshner, Ph.D., Chief Executive Officer of the American Association for the Advancement of Science and chair of the conference panel explained, "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. 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."

The panel's full statement discusses the specific challenges facing this area of research and recommends a variety of studies to help clarify the disorder's underlying mechanisms, natural history, the interaction between insomnia and other conditions, and the comparative risks and benefits of various therapies.

The panel released its findings this morning, following two days of expert presentations and panel deliberations. Full text of the panel's draft state-of-the-science statement will be available late today at http://consensus.nih.gov. The final version will be available at the same Web address in three to four weeks. Statements from past conferences and additional information about the NIH Consensus Development Program are also available at the Web site, or by calling 1-888-644-2667.

The 12 members of this State-of-the-Science panel were nominated for selection by peers who were confident that these individuals' areas of expertise would significantly contribute to the process of critically examining scientific evidence on insomnia. The panel included educators, researchers, statisticians, and practitioners in neuroscience, anesthesiology, sleep disorders, geriatric medicine, psychology, psychiatry, epidemiology, health services research, nursing, and community medicine.

In addition to the presentations of conference speakers, the panel considered a comprehensive systematic literature review prepared by the University of Alberta Evidence-Based Practice Center, under contract with the Agency for Healthcare Research and Quality (AHRQ).

The panel's statement is an independent report and is not a policy statement of the NIH or the Federal Government. The NIH Consensus Development Program, of which this conference is a part, was established in 1977 as a mechanism to judge controversial topics in medicine and public health in an unbiased, impartial manner. NIH has conducted 119 consensus development conferences, and 25 state-of-the-science (formerly "technology assessment") conferences, addressing a wide range of issues.

The conference was sponsored by the Office of Medical Applications of Research (OMAR) and the National Institute of Mental Health. Cosponsors included the National Center for Complementary and Alternative Medicine, the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, the National Institute of Nursing Research, the National Institute on Aging, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the Office of Research on Women's Health, and the U.S. Food and Drug Administration.