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Eszopiclone does not impair next-day driving ability, cognition relative to placebo, researchers report

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Nighttime administration of eszopiclone 3 mg may improve objective and subjective sleep measures in patients with primary insomnia without impairing next-day driving ability or other measures of cognition and psychomotor function, new data reveal.

To evaluate the effect of nighttime administration of eszopiclone on next-day driving ability and cognitive function, researchers conducted a double-blind, crossover study in which 31 patients aged 20 to 55 years with primary insomnia received eszopiclone 3 mg or placebo at 10:30 p.m. Driving ability, including brake reaction time, was assessed the following morning, approximately 9.5 hrs after dosing (8:00 a.m. to 8:45 a.m.), using a dual-controlled car on a closed-circuit track. Objective cognitive and psychomotor functions were then assessed (8:15 a.m. to 9:00 a.m.) using Critical Flicker Fusion, Choice Reaction Time, Continuous Tracking Task, Rapid Visual Information Processing, Sternberg Short Term Memory Scanning Task, and Digital Symbol Substitution Test. Hypnotic efficacy was assessed objectively through polysomnography and subjectively through the Leeds Sleep Evaluation Questionnaire (LSEQ).

Results showed no significant difference in brake reaction time between patients in the eszopiclone and placebo groups (P>.05).

Further, scores on tests of cognitive and psychomotor function of patients in the eszopiclone group were not significantly different from those of patients in the placebo group, except in the quality of sleep and the ease of getting to sleep subdomains of the LSEQ, which were significantly better among patients in the eszopiclone group (P<.0001 for both).

As compared with placebo, eszopiclone significantly improved 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). Patients who received eszopiclone also reported subjective improvements in sleep induction, maintenance, and duration (P<.05).

Patients in the eszopiclone group reported 27 adverse events compared with 10 adverse events in the placebo group. The most common adverse events reported in the eszopiclone group were unpleasant taste (23%) and fatigue (13%).

"The results of this study are consistent with previous studies that demonstrate that recommended nighttime dosing of eszopiclone is not associated with next-day residual effects in most patients," the authors concluded. "Notwithstanding, patients receiving eszopiclone should be cautioned about potential impairment when operating machinery or driving a motor vehicle on the day following ingestion." (Boyle J, et al. Poster NR616.)

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