We investigated the impact of eszopiclone 3mg on next day driving ability (on-the-road brake-reaction-time, BRT) and cognitive and psychomotor performance in patients with primary insomnia.

Patients with DSM-IV primary insomnia completed this study. Treatment was administered 30min before bedtime, and next day driving ability was assessed by on-the-road BRT approximately 9.5 hours postdose. A cognitive test battery measured residual effects on information processing, divided attention, psychomotor tasks, and working memory. Overnight polysomnography was conducted to assess sleep architecture; subjective ratings of morning sedation and sleep quality were also obtained.

There were no significant differences in BRT following night time administration of eszopiclone 3mg compared with placebo (p=0.39) and there were no significant differences in objective cognitive tests of information processing, divided attention, psychomotor tasks and working memory (p values>0.15). No significant effect on subjective next day ratings of morning sedation, coordination or mood was observed (p values>0.22). There was improvement compared with placebo (p<0.0001) in subjective ease of getting to sleep and quality of sleep the morning following dosing, and no perceived impairment of behavior following awakening or early morning awakenings. Polysomnography demonstrated significant improvements in sleep onset and maintenance.

In this study, the first to assess next day on-the-road driving in primary insomniacs following hypnotic use, eszopiclone 3mg improved both objective and subjective measures of sleep onset and maintenance without residual impairments on next day driving ability or cognitive and psychomotor performance.

Support for this study provided by Sepracor Inc., Marlborough, MA.