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A single-dose zopiclone 7.5 mg also increased SDLP as expected. Acute driving impairment was more pronounced after both doses of esmirtazapine in a select group of poor metabolizers (N = 7). Driving impairment, i.e., a rise in SDLP, did occur after a single-dose administration of esmirtazapine 4.5 mg but was resolved after repeated doses. RESULTS: Overall, esmirtazapine 1.5 mg did not produce any clinically relevant change in SDLP after single and repeated dosing. All subjects were subjected to CYP2D6 phenotyping in order to distinguish poor metabolizers from extensive metabolizers of esmirtazapine. The primary study parameter was standard deviation of lateral position (SDLP), a measure of 'weaving'. Driving performance was assessed in the morning, 11 h after drug intake, in a standardized on-the-road highway driving test.

METHODS: Treatments were administered in the evening. Treatment with single doses of zopiclone 7.5 mg was included as active control. PURPOSE: The present study was designed to assess residual effects of single and repeated doses of esmirtazapine 1.5 and 4.5 mg on actual driving in 32 healthy volunteers in a double-blind, placebo-controlled study. INTRODUCTION: Esmirtazapine is evaluated as a novel drug for treatment of insomnia.

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