An assessment of the efficacy and safety of eszopiclone in the treatment of transient insomnia in healthy adults

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 3.5 mg, 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 significant ly less PSG latency to persistent sleep (all doses except 1 mg; P≤0.0001), wake time after sleep onset (all doses; P≤0.05) and number of awakenings (3 and 3.5 mg doses; P<0.005), and greater sleep efficiency (all doses; P≤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 3.5 mg 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. © 2004 Elsevier B.V. All rights reserved.