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


METHODS
Randomized, double-blind, placebo-controlled multicenter in outpatient setting with weekly visits.


METHODS
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.


METHODS
Eszopiclone 1 mg (n = 72), eszopiclone 2 mg (n = 79), or placebo (n = 80) nightly for 2 weeks.


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 < or = .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.


CONCLUSIONS
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.
Scharf
Martin
M
Tri-State Sleep Disorders Center, Cincinnati, OH 45246, USA. ggaz@tristatesleep.com
Erman
Milton
M
Rosenberg
Russell
R
Seiden
David
D
McCall
W Vaughn
WV
Amato
David
D
Wessel
Thomas C
TC
D000368:Aged; D053961:Azabicyclo Compounds; D015992:Body Mass Index; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; C515050:zopiclone