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Journal Article

Citation

Vuurman E, Theunissen E, Van Oers A, Van Leeuwen C, Jolles J. Hum. Psychopharmacol. 2007; 22(5): 289-297.

Affiliation

Brain and Behaviour Institute, Faculty of Medicine, Maastricht University, The Netherlands. e.vuurman@np.unimaas.nl

Copyright

(Copyright © 2007, John Wiley and Sons)

DOI

10.1002/hup.856

PMID

17599335

Abstract

INTRODUCTION: Rupatadine fumarate is a potent, selective, histamine H(1)-receptor antagonist and PAF inhibitor with demonstrated efficacy for the relief of allergic rhinitis. Rupatadine does not easily cross the blood-brain barrier and is believed to be non-sedating at therapeutic doses. Consequently, rupatadine should show no impairment on car driving. OBJECTIVE: This study compared the acute effects of rupatadine, relative to placebo and hydroxyzine (as an active control), on healthy subjects' driving performance. METHODS: Twenty subjects received a single dose of rupatadine 10 mg, hydroxyzine 50 mg, or placebo in each period of this randomized, double-blind, three-way crossover study. Two hours postdosing, subjects operated a specially instrumented vehicle in tests designed to measure their driving ability. Before and after the driving tests ratings of sedation were recorded. RESULTS: There was no significant difference between rupatadine and placebo in the primary outcome variable: standard deviation of lateral position (SDLP); however, hydroxyzine treatment significantly increased SDLP (p < 0.001 for both comparisons). Objective (Stanford sleepiness scale) and subjective sedation ratings (Visual Analogue Scales) showed similar results: subjects reported negative effects after hydroxyzine but not after rupatadine. CONCLUSION: Rupatadine 10 mg is not sedating and does not impair driving performance.


Language: en

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