title: Acute and subchronic effects of bilastine (20 and 40 mg) and hydroxyzine (50 mg) on actual driving performance in healthy volunteers.
abstract: Bilastine is a new second-generation H1 antagonist. Although bilastine has been demonstrated to produce little or no performance impairment in laboratory tests, it cannot be excluded that it produces impairments in real-life performance such as driving. This study aims to assess the effects of two doses of bilastine (20 and 40 mg) on actual driving after single and repeated administration. Hydroxyzine 50 mg was included as an active control. Twenty-two participants (11 females, 11 males) were tested in a placebo-controlled, randomized, double-blind, four-way cross-over design. Participants were treated with once-daily doses for eight consecutive days. On day 1 and 8 of each treatment period participants performed an actual highway driving test. The primary variable was standard deviation of lateral position (SDLP), a measure of weaving. Results demonstrated that hydroxyzine significantly increased SDLP on days 1 and 8 of treatment. Bilastine did not affect SDLP. It is concluded that hydroxyzine produces severe driving impairment after single doses and that this impairment only partly mitigates over time due to a lack of complete tolerance. Bilastine did not produce any driving impairment after single and repeated doses and can be safely used in traffic in doses up to 40 mg.
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands. silke.conen@maastrichtuniversity.nl
authors.forename: Silke
authors.initials: S
authors.lastname: Conen
authors.forename: Eef L
authors.initials: EL
authors.lastname: Theunissen
authors.forename: Anita C M
authors.initials: AC
authors.lastname: Van Oers
authors.forename: Román
authors.initials: R
authors.lastname: Valiente
authors.forename: Johannes G
authors.initials: JG
authors.lastname: Ramaekers
mesh_terms: D000328:Adult; D001334:Automobile Driving; D001562:Benzimidazoles / Q000009:adverse effects / Q000494:pharmacology*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D006919:Hydroxyzine / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects / Q000494:pharmacology*; D011597:Psychomotor Performance / Q000187:drug effects*; D055815:Young Adult
chemical_list: D001562:Benzimidazoles; D039563:Histamine H1 Antagonists, Non-Sedating; D010880:Piperidines; D006919:Hydroxyzine; C445659:bilastine