Residual effects of esmirtazapine on actual driving performance: Overall findings and an exploratory analysis into the role of CYP2D6 phenotype

Abstract

Introduction: Esmirtazapine is evaluated as a novel drug for treatment of insomnia. 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. Treatment with single doses of zopiclone 7.5 mg was included as active control. Methods: Treatments were administered in the evening. Driving performance was assessed in the morning, 11 h after drug intake, in a standardized on-the-road highway driving test. The primary study parameter was standard deviation of lateral position (SDLP), a measure of "weaving". All subjects were subjected to CYP2D6 ..