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Eszopiclone appears to improve sleep in people with primary insomnia without next-day impairments in cognitive, psychomotor performance, driving abilities

Thursday, December 13 2007 | Comments
Evidence Grade 0 What's This?
Among people with primary insomnia, a single night of treatment with eszopiclone improves sleep onset and maintenance and is not associated with next-day impairments in cognitive and psychomotor performance or driving ability, suggest findings from a randomized, double-blind, crossover study.

Researchers recruited 31 participants with primary insomnia for the study. Volunteers received treatment with eszopiclone 3 mg and placebo (in a randomized order), with a 7-day washout period between treatments. Treatment was administered at 10:30 p.m. (30 minutes before bedtime).

Next-day driving ability was assessed approximately 9.5 hours postdose with on-the-road brake reaction time (BRT) in a dual-controlled car on a closed-circuit track. Participants also completed the Leeds Analog Rating Scale (LARS) and a cognitive test battery; the latter was used to evaluate residual effects of treatment on information processing, divided attention, psychomotor tasks, and working memory. Sleep was assessed using overnight polysomnography (PSG) and the Leeds Sleep Evaluation Questionnaire (LSEQ).

There were no statistically significant differences between eszopiclone and placebo in on-the-road BRT (P=.34) or in any of the cognitive and psychomotor assessments (P≥.10 for all). Similarly, there were no significant between-group differences in next-day ratings of morning sedation, coordination, and mood (assessed with LARS) or in next-day assessments of early morning awakenings and impaired behavior (assessed with LSEQ).

However, significant differences favoring eszopiclone were seen in LSEQ ratings of subjective ease of getting to sleep and sleep quality (P≤.0001 for both).

PSG data corroborated LSEQ results. Specifically, relative to placebo, eszopiclone significantly improved PSG-measured sleep efficiency (P<.001), total sleep time (P<.001), latency to persistent sleep (P<.0001), time awake (P<.01), and wake after sleep onset (P<.01).

Twenty-seven adverse events were reported after treatment with eszopiclone, and 10 were reported after treatment with placebo. The most frequently reported adverse events with eszopiclone were unpleasant taste (23%) and fatigue (13%).

The study authors noted that the current trial is the first to evaluate next-day on-the-road driving ability following hypnotic use in individuals with insomnia.

Although these data suggest that the drug is not associated with next-day residual effects in most individuals, the authors cautioned that those who take eszopiclone should still be warned of potential impairment when operating machinery or driving the day after dosing. (Rubens R, et al. P04.034.)

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