National Institutes of Health State-of-the Science Statement on Chronic Insomnia in Adults

By Dr. Gregg D. Jacobs
June 27, 2005

On June 13-15, 2005 , the National Institutes of Health held an important and historic State-of-the-Science Conference on the manifestations and management of chronic insomnia in adults. This conference involved an independent panel of health care professionals, clinicians, scientists, and the public and was the first gathering in over 20 years of sleep experts specifically involved with research and clinical aspects of chronic insomnia. Over three days, experts presented the latest scientific knowledge about chronic insomnia and its treatments; and, oral and written input from professionals and the public was heard. The panel, after weighing all of the scientific evidence, prepared and presented a draft of the state-of-the-science statement. Professionals and the public then offered commentary and feedback on the draft statement. The present draft and the final statement (which will be posted in 4 weeks) can be seen at consensus.nih.gov .

The draft statement highlighted numerous critical issues in the treatment of insomnia, including the following:

• There has been limited research on the treatment of insomnia. For this reason, the NIH chose to hold a state-of-the science conference instead of a consensus conference, which requires that a substantial amount of research has been conducted on insomnia. Accordingly, there is a great deal of new research needed on treatments for insomnia
• There has been a paucity of large- randomized trials for any widely used treatments that include pharmacotherapy, cognitive-behavioral therapy (CBT), over the counter products (OTCs), and herbal remedies
• The most common treatments for chronic insomnia are OTCs, alcohol, and prescription medications
• CBT has demonstrated efficacy in the treatment of insomnia. CBT is as effective as sedative-hypnotic pharmacotherapy. Moreover, there is evidence that the beneficial effects of CBT, in contrast to those produced by medications, last well beyond the termination of treatment. However, because few clinicians are experts in the use of CBT, its use is not widespread. Future research will need to address methods for wider dissemination of CBT, including possible methods such as the internet. Future training efforts should be devoted to increasing the number of CBT clinicians which has been estimated at only several hundred world-wide
• Sedative-hypnotics are effective in the short-term management of insomnia. However, most studies have averaged only 7 days and only one study has assessed efficacy at 6 months. Adverse effects of these medications include daytime sedation, cognitive impairment, motor incoordination, dependence, and rebound insomnia. The frequency of these side effects is much lower in the newer hypnotics such as Ambien, Sonata, and Lunesta. There is little research on the comparative efficacy of one medication versus another
• There is evidence that sedating antidepressants such as trazodone are now the most widely prescribed medications for insomnia despite their off-label use for this purpose. Although a few studies have shown that these medications are effective for a few weeks, there are no studies showing that these medications work for more that 2-4 weeks. They also have significant side effects
• There is no evidence that OTCs, melatonin, or herbal remedies are more effective than a placebo
• There is a need for large-scale, multicenter randomized clinical trials involving sedative-hypnotics and CBT. Drug trials should compare at least two medications (instead of comparing one medication to a placebo). Drug studies must also compare the effect and side effects over much longer periods of time (perhaps years) and assess the effects after the drug is discontinued.
• Studies should assess the efficacy of CBT and drugs in terms of normal sleep
• The pharmaceutical industry is called upon to conduct large-scale randomized trials comparing at least 2 drugs and comparing CBT to drugs.