Authors: McCall, W. Vaughn¹; Erman, Milton²; Krystal, Andrew D.³; Rosenberg, Russell⁴; Scharf, Martin⁵; Zammit, Gary K.⁶; Wessel, Thomas⁷

Source: Current Medical Research and Opinion, Volume 22, Number 9, September 2006 , pp. 1633-1642(10)

Publisher: Informa Healthcare

Abstract:

Objective: To evaluate the safety and efficacy of eszopiclone 2 mg in elderly patients (aged 64-86 years) with chronic insomnia.

Methods: This was a randomized, double-blind, placebo-controlled 2-week study. Patients meeting DSM-IV criteria for primary insomnia and screening polysomnography criteria (wakefulness after sleep onset [WASO] ≥ 20 min and latency to persistent sleep ≥ 20 min) were randomized to 2 weeks of nightly treatment with eszopiclone 2 mg (n = 136) or placebo (n = 128). Efficacy was assessed using polysomnography (Nights 1, 2, 13, and 14) and patient reports (Nights 1-14); safety was assessed using adverse events, clinical labs, physical examination, and vital signs. The mean of all efficacy results during the double-blind period was used for the efficacy analysis.

Results: Results indicated that eszopiclone was associated with significantly shorter sleep onset, less WASO, higher sleep efficiency, more total sleep time, and greater patient-reported quality and depth of sleep scores than placebo (p < 0.05 for all) with a trend in patient-reported morning sleepiness (p = 0.07). Other measures of daytime functioning (ability to function, daytime alertness, and sense of well-being) were not significantly different between the two treatment groups. Among patients who napped, eszopiclone patients reported fewer naps (p = 0.03) and less cumulative naptime (median: 98 min placebo, 70 min eszopiclone, p = 0.07). Unpleasant taste, dry mouth, somnolence, and dizziness were higher in the eszopiclone group (12.5%, 8.8%, 6.6%, and 6.6%, respectively) than in the placebo group (0%, 1.6%, 5.5%, and 1.6%, respectively).

Conclusion: In this study, eszopiclone was well tolerated and produced significant improvements in both polysomnographic and patient-reported measures of sleep maintenance, sleep induction, and sleep duration in elderly patients with chronic primary insomnia.

Keywords: ELDERLY; ESZOPICLONE; INSOMNIA; POLYSOMNOGRAPHY; SLEEP MAINTENANCE; SLEEP ONSET

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079906X112741

Affiliations: 1: Wake Forest University Health Sciences, Winston-Salem, NC, USA 2: Pacific Sleep Medicine Services, Inc. San Diego, CA, USA 3: Duke University Medical Center, Psychiatry and Behavioral Sciences, Durham, NC, USA 4: Northside Hospital, Atlanta, GA, USA 5: Tristate Sleep Disorders Center, Cincinnati, OH, USA 6: Columbia University College of Physicians and Surgeons, New York, NY, USA 7: Sepracor Inc., Marlborough, MA, USA

Publication date: 2006-09-01

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