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The purpose of the present clinical study was to evaluate the sedative effects of Drewell® (50mg of diphenhydramine hydrochloride). The study was conducted with a randomized, placebo-controlled, cross over design in eight healthy male volunteers. Subjects took either a Drewell® or a matched placebo tablet on two occasions with more than a 6-day wash-out period. The sedative effects on central nervous system (CNS) were assessed using both objective evaluation (saccadic eye movement analysis) and subjective evaluation (Visual Analogue Scale: VAS). Statistical analyses for pharmacodynamic parameters were performed by repeated measures-ANOVA. Saccadic peak velocity (SPV), one of the sensitive parameters for sedative effects, showed a significant decline in the Drewell group compared with the placebo group.In the VAS evaluation, a sedative effect was also detected in the Drewell group.Despite some inter-individual differences of SPV values, in both the Drewell and the placebo sessions SPV baseline values within the same subject were quite similar. This suggests that subjects might have their own SPV values and those values might be reproducible. In addition, it was also confirmed that objective and quantitative evaluations of the sedative effects of Drewell® were possible using saccadic eye movement analysis.

rinshou yakuri/rinshō yakuri

A Clinical Pharmacological Study to Evaluate the Sedative Effects of the Antihistaminic Drug, Diphehydramine Hydrochloride (Drewell): Objective Evaluation of the Sedative Effects by Analysis of Saccadic Eye Movement