Insomnia is one of the most common health problems in the United States. An estimated 30 to 50 percent of adults experience episodes of acute insomnia at some point in time. Chronic insomnia, lasting more than three months and affecting daytime function, affects about 6 percent of adults. Insomnia causes fatigue, confusion, mood disturbances, and is associated with depression, anxiety, cardiovascular disease, diabetes, and respiratory diseases.
Treatment options for insomnia include education on sleep hygiene, over the counter medications or supplements, behavioral and psychological interventions such as cognitive behavioral therapy (CBT-I), and prescription medications. While many treatments for insomnia are available, clinicians often resort to pharmacologic interventions. A CDC report estimated that 4 percent of adults aged 20 and over in the U.S. used prescription sleep aids in the past month. The percentage of adults using prescription sleep aids increases with age, and is higher among women and non-Hispanic whites. Prescription sleep aids are approved for short term use (i.e., one month or less), but are often used long-term.
Although many patients are taking prescription sleep aids, a paucity of head-to-head comparisons of drugs, comparisons of drugs versus psychological therapies, or comparisons of combination therapies remains. Moreover, recent FDA Drug Safety Communications raised new questions regarding the appropriate dosing of prescription sleep aid treatment, particularly for women and older adults. In addition, existing evidence is often limited to clinical sleep measures, rather than patient-important outcomes such as function, mood, and quality of life.
As part of PCORI’s efforts to fund high-impact and useful research on critical patient-centered health and healthcare issues, PCORI convened a multi-stakeholder workshop to discuss research needs for the comparative effectiveness of treatments for chronic insomnia. PCORI will use feedback from the workshop to better understand the research needs as we explore a possible funding announcement in this area.
Participation in the discussion was by invitation only, but the public could listen in via teleconference/webinar.