Abstract:
BACKGROUND AND PURPOSE: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. PATIENTS AND 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.
journal_name
Sleep Medjournal_title
Sleep medicineauthors
Rosenberg R,Caron J,Roth T,Amato Ddoi
10.1016/j.sleep.2004.09.001keywords:
subject
Has Abstractpub_date
2005-01-01 00:00:00pages
15-22issue
1eissn
1389-9457issn
1878-5506pii
S1389-9457(04)00162-5journal_volume
6pub_type
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