Download Atlantis Word Processor 4.3.1.74/10/2024 Rationale Alprazolam extended-release (XR) is approved for the treatment of panic disorder. Exploratory analysis in a small group of poor CYP 2D6 metabolizers suggested that these subjects are more sensitive to the impairing effects of esmirtazapine on car driving. Single-dose administration of 4.5 mg esmirtazapine was associated with residual impairment that generally resolved after repeated administration. CONCLUSION: It is concluded that single and repeated doses of 1.5 mg esmirtazapine are generally not associated with residual impairment. 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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