Objective: The elderly suffer disproportionately from insomnia (prevalence~57%). Sleep maintenance is the most commonly reported problem. Eszopiclone is a novel, non-benzodiazepine, cyclopyrrolone, anti-insomnia agent developed to rapidly induce and maintain sleep throughout the night without next day effects. This study was conducted to determine the efficacy and safety of eszopiclone in elderly patients with chronic insomnia.
Design: Multi-center, randomized, double-blind, placebo-controlled, parallel group study.
Methods: Eligibility included age 65-85 years, DSM-IV criteria for primary insomnia, duration of sleep <6.5 hours per night with sleep latency (SL) >30 minutes for at least 1 month, with no minimum requirement for wake time after sleep onset (WASO). Patients were randomized to receive nightly treatment with placebo or eszopiclone (1 or 2mg) for 2 weeks. Subjective data were collected each morning and evening using an interactive voice response system. Subjective endpoints included the sleep maintenance parameter WASO, SL, total sleep time (TST), quality, and depth of sleep. Safety endpoints were also evaluated. Morning sleepiness, daytime alertness, ability to function, and number and duration of naps were captured each evening.
Results: Of 231 randomized patients, 210 (91%) completed the study. Most discontinuations were due to voluntary withdrawal (4.8%). The mean age was 72.3±4.9 years, and the majority of patients were female (57%) and Caucasian (97%). Eszopiclone 2mg significantly improved sleep maintenance (reduced WASO) compared with placebo at Week 1 and Week 2 (p<0.05). Over the 2-week period, eszopiclone 2mg significantly increased TST by approximately 40 min/night (p<0.001) and significantly improved the quality (p<0.001) and depth (p<0.002) of sleep compared with placebo. Both eszopiclone doses significantly decreased SL compared with placebo (p<0.004). Eszopiclone 2mg significantly reduced the number of naps taken compared with placebo at Week 2 (median = 0 and 2, respectively; p<0.05), and both doses significantly decreased total nap time over the treatment period (145, 175, and 291 minutes for eszopiclone 2mg, 1mg, and placebo, respectively; p<0.05). Patients treated with eszopiclone 2mg reported significant improvements in daytime alertness (p<0.05) and sense of well-being (p<0.05) at Weeks 1 and 2, improved daytime ability to function at Week 2 (p<0.05), and a decrease in morning sleepiness compared with placebo. Treatment was well tolerated over the study. The most common adverse event was headache (15% in placebo and active groups).
Conclusion: In this study in elderly patients with chronic insomnia, eszopiclone 2mg significantly improved subjective endpoints of sleep latency, quality and depth of sleep, increased TST, and produced sleep maintenance throughout the night by significantly reducing WASO. Eszopiclone also resulted in next day benefits and significantly reduced the number and duration of naps over the study period.
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