An assessment of the efficacy and safety of eszopiclone in the treatment of transient insomnia in healthy adults.
OBJECTIVE
This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of eszopiclone, a non-benzodiazepine hypnotic agent, in healthy adults using the first-night effect model of transient insomnia.


METHODS
A total of 436 healthy, normal sleeping participants were randomized to receive either eszopiclone 1, 2, 3, or 3.5mg, or placebo. Efficacy and next-morning effects were evaluated via polysomnography (PSG), Digit Symbol Substitution Test (DSST), and self-report.


RESULTS
Patients treated with eszopiclone had significantly less PSG latency to persistent sleep (all doses except 1mg; P< or =0.0001), wake time after sleep onset (all doses; P< or =0.05) and number of awakenings (3 and 3.5mg doses; P<0.005), and greater sleep efficiency (all doses; P< or =0.02) compared with placebo. Self-reported efficacy results were similar to PSG. Self-reported morning sleepiness scores were significantly better for eszopiclone 3 and 3.5mg compared with placebo (P<0.05). Treatment was well tolerated by patients, and the most common treatment-related adverse event was unpleasant taste.


CONCLUSIONS
In this model of transient insomnia, all doses of eszopiclone were more effective than placebo and were well tolerated by patients.
Rosenberg
Russell
R
Northside Hospital Sleep Medicine Institute, 5780 Peachtree Dunwoody Road, Suite 150, Atlanta, GA 30342, USA. rosenberg@mindspring.com
Caron
Judy
J
Roth
Thomas
T
Amato
David
D
D000328:Adult; D053961:Azabicyclo Compounds; D002940:Circadian Rhythm; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007360:Intelligence / Q000187:drug effects; D007361:Intelligence Tests; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D017286:Polysomnography; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000503:physiopathology*; D012894:Sleep Stages / Q000187:drug effects; D013649:Taste / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects
D053961:Azabicyclo Compounds; D010879:Piperazines; C515050:zopiclone