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Drug Class Review: Newer Drugs for Insomnia: Final Report Update 2 [Internet]

Drug Class Review: Newer Drugs for Insomnia: Final Report Update 2 [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: October 2008


Table 11 summarizes the quality of the overall body of evidence for each key question.


We identified 2570 citations from literature searches, reviews of reference lists, and citations from dossiers submitted by 2 pharmaceutical manufacturers, Sanofi-Aventis (zolpidem extended release) and Takeda (ramelteon). After applying the eligibility and exclusion criteria to titles and abstracts, we obtained the full text of 370 publications. After reapplying the criteria for inclusion, we included 205 studies. The flow of study inclusion and exclusion is detailed in Figure 1. A list of excluded trials is provided in Appendix C.


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. Variation in estimates depends on different methods of surveying and definitions of insomnia. About three-fourths of people who have trouble sleeping say that the problem is “occasional,” averaging about 6 nights per month. The other one-fourth have 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. The most common symptoms of insomnia are waking up feeling unrefreshed and waking often during the night. The symptoms waking up too early and difficulty falling asleep are less common but still experienced at least a few nights a week by about 25% of adults with insomnia. The risk of insomnia increases with age; affecting approximately 20% to 40% of older adults at least a few nights per month.

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