Effects of WAL 801 CL (Epinastine hydrochloride) on Actual Driving Performance.

ASOH, Tsutomu; OKAMOTO, Koichi; SAKAI, Yutaka · 1992 · Crossref

DOI: 10.3999/jscpt.23.507

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Summary

This study investigated the impact of WAL 801 CL (epinastine hydrochloride), a new non-sedating H1-receptor antagonist, on actual driving performance. The research was motivated by the known central nervous system (CNS) depressant effects of traditional antihistamines, which cause drowsiness and impair driving ability, posing significant safety risks. While previous studies suggested epinastine lacks sedative properties, this study aimed to confirm its safety during real-world driving conditions compared to a placebo and the sedating antihistamine d-chlorpheniramine. The researchers conducted a randomized, double-blind, crossover trial involving 12 healthy male volunteers with driver’s licenses. Participants underwent three separate testing sessions, receiving either 20 mg of epinastine, 6 mg of d-chlorpheniramine, or a placebo. Driving performance was assessed using an on-the-road study on a 7 km closed circuit designed to simulate general road conditions. Subjects drove continuously for up to 120 minutes at approximately 60 km/h. Physiological and performance metrics were continuously recorded, including electroencephalogram (EEG) alpha activity, eye movement (specifically slow blinking frequency), steering wheel manipulation (frequency of large steering angles >10 degrees), and subjective sleepiness measured by the Stanford Sleepiness Scale (SSS). The results demonstrated that epinastine did not impair driving performance. The duration of continuous driving, EEG alpha activity ratios, slow blinking frequency, and SSS scores for the epinastine group were not significantly different from the placebo group. In contrast, the d-chlorpheniramine group showed significant impairment: only 6 of 12 subjects completed the 120-minute drive, and the remaining subjects were stopped due to dangerous drowsiness. The d-chlorpheniramine group exhibited significantly higher EEG alpha activity, increased slow blinking, more frequent large steering corrections, and higher subjective sleepiness scores compared to both the epinastine and placebo groups. The study concludes that WAL 801 CL (epinastine) is a non-sedating H1-receptor antagonist that does not influence overall driving ability or induce CNS depression during driving. Unlike traditional antihistamines such as d-chlorpheniramine, epinastine allows patients to maintain alertness and safe vehicle control, supporting its use in individuals who require driving capabilities while undergoing allergy treatment.

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