A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia

Martin Scharf, Milton Erman, Russell Rosenberg, David Seiden, W. Vaughn McCall, David Amato, Thomas C. Wessel

Research output: Contribution to journalArticle

105 Scopus citations

Abstract

Study Objectives: Evaluate the efficacy of eszopiclone in primary insomnia. Design/Setting: Randomized, double-blind, placebo-controlled multicenter in outpatient setting with weekly visits. Participants: Two-hundred thirty one men and women aged 65 to 85 years (mean age 72.3 years) with primary insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition. Interventions: Eszopiclone 1 mg (n = 72), eszopiclone 2 mg (n = 79), or placebo (n = 80) nightly for 2 weeks. Measurements/Results: Efficacy was assessed using an interactive voice response system. Following the predefined hierarchical testing strategy, the eszopiclone 2-mg group had a significantly shorter sleep latency compared with placebo over the double-blind period (P = .0034). The eszopiclone 2-mg group had significantly longer total sleep time (P = .0003) and eszopiclone 1-mg group had significantly shorter sleep latency (P ≤ .012) compared with placebo. The eszopiclone 1-mg group was not significantly different from placebo on total sleep time or any other secondary efficacy endpoint. Secondary analyses indicated that the eszopiclone 2-mg group had significantly less wake after sleep onset; significantly fewer and shorter in duration daytime naps; and significantly higher ratings of sleep quality and depth, daytime alertness, and sense of physical well-being compared with placebo (P < .05). Eszopiclone was well tolerated. The most frequent treatment-related adverse event was unpleasant taste. Conclusion: Nightly treatment with eszopiclone 1 mg effectively induced sleep, while the 2-mg dose was effective in inducing and maintaining sleep. Eszopiclone was well tolerated in elderly patients with primary insomnia, and the sleep efficacy was accompanied by significantly less napping and significantly higher ratings of daytime alertness, sense of physical well-being, and several quality-of-life parameters at the higher dose.

Original languageEnglish (US)
Pages (from-to)720-727
Number of pages8
JournalSleep
Volume28
Issue number6
DOIs
StatePublished - Jun 1 2005
Externally publishedYes

Keywords

  • Daytime function
  • Elderly
  • Eszopiclone
  • Insomnia
  • Quality of life
  • Sleep disturbance
  • Sleep latency
  • Sleep maintenance
  • WASO

ASJC Scopus subject areas

  • Clinical Neurology
  • Physiology (medical)

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    Scharf, M., Erman, M., Rosenberg, R., Seiden, D., McCall, W. V., Amato, D., & Wessel, T. C. (2005). A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia. Sleep, 28(6), 720-727. https://doi.org/10.1093/sleep/28.6.720