Silexan does not affect driving performance after single and multiple dose applications: Results from a double-blind, placebo and reference-controlled study in healthy volunteers

Anxiolytic drugs often have sedative effects that impair the ability to drive. Our double-blind, randomized crossover trial investigated effect of Silexan, a non-sedating, anxiolytic herbal medicinal product, on driving performance in healthy volunteers. Part 1 aimed at demonstrating equivalence between 80 mg/d Silexan and placebo. 2 was performed demonstrate superiority 160 320 mg over lorazepam included placebo arm for assay sensitivity. Driving assessed validated, alcohol-calibrated simulator test. The primary outcome standard deviation lane position (SDLP). Secondary outcomes errors sleepiness. Fifty 25 subjects were Parts 2, respectively. In 1, confirmed be equivalent after single administration (equivalence range: δ = ±2 cm). 95% confidence interval (CI) SDLP marginal mean value difference Silexan–placebo −1.43; +1.38 thus similar CI −1.45; +0.79 cm 7 days’ multiple dosing. CIs differences −8.58; −5.42 −8.65; −5.45 (p < 0.001). Confirmatory results supported by secondary outcomes, where comparable more favorable than lorazepam. study demonstrates doses up no adverse performance.