Insomnia is a serious health problem that affects millions of people. Population surveys have estimated the prevalence of insomnia to be about 30% to 50% of the general population. About three-fourths of people who have trouble sleeping say that the problem is "occasional," averaging about 6 nights per month, with one-fourth having frequent or chronic insomnia, averaging about 16 nights per month. Individuals with insomnia most often report a combination of difficulty falling asleep and intermittent wakefulness during sleep. Treatment of insomnia involves behavioral changes, such as minimizing habits that interfere with sleep (for example, drinking coffee or engaging in stressful activities in the evening), and pharmacotherapy with sedating antidepressants (for example, trazodone), sedating antihistamines, anticholinergics, benzodiazepines, or nonbenzodiazepine hypnotics. The benzodiazepines and the newer sedative hypnotics zolpidem, zaleplon, zopiclone, and eszopiclone work through gamma-aminobutyric acid receptors. Ramelteon, a hypnotic approved by the United States Food and Drug Administration (FDA) in July 2005, is a selective melatonin receptor (MT1 and MT2) agonist. New nonbenzodiazepine drugs have been sought for multiple reasons, including reduction of the risk of tolerance, dependence, and abuse associated with benzodiazepines. The purpose of this review is to evaluate the comparative evidence on benefits and harms of these medications in people with insomnia to help policymakers and clinicians make informed choices about the use of newer drugs for insomnia.

Contents

• Introduction
  • Scope and Key Questions
  • Included populations
  • Included interventions
  • Included outcomes
• Methods
  • Literature Search
  • Study Selection
  • Data Abstraction
  • Validity Assessment
  • Data Synthesis
• Results
  • Overview of included studies
  • Key Question 1. What is the comparative effectiveness of newer drugs in treating adults and children with insomnia?
  • Key Question 2. What are the comparative tolerability and safety of newer drugs for insomnia when used to treat patients with insomnia?
  • Key Question 3. Are there subgroups of patients for which one newer drug for insomnia is more effective or associated with fewer adverse events?
• Summary
• References
• Appendix A. Literature search strategies
• Appendix B. Quality assessment methods for drug class reviews for the Drug Effectiveness Review Project
• Appendix C. Excluded studies
• Appendix D. Summary of results of trials comparing newer insomnia drugs compared with benzodiazepines
• Evidence Tables

The funding source, the Center for Evidence-based Policy, is supported by 17 organizations, including 15 state Medicaid programs. These organizations selected the topic and had input into the Key Questions of this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report.

Suggested citation:

Carson S, McDonagh M, Thakurta S, Yen P. Drug class review: Insomnia. 2008. http://www.ohsu.edu/drugeffectiveness/reports/final.cfm

The purpose of this report is to make available information about comparative effectiveness and safety profiles of different drugs within a pharmaceutical class. This report does not provide usage guidelines nor should it be read as an endorsement of, or recommendation for, any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.