Citation

Vuurman EF, Rikken GH, Muntjewerff ND, de Halleux F, Ramaekers JG. Eur. J. Clin. Pharmacol. 2004; 60(5): 307-313.

Affiliation

Experimental Psychopharmacology Unit, Department of Psychiatry and Neuropsychology, P.O. Box 616, 6200 MD Maastricht, The Netherlands. e.vuurman@np.unimaas.nl

Copyright

(Copyright © 2004, Holtzbrinck Springer Nature Publishing Group)

DOI

10.1007/s00228-004-0757-9

PMID

15168099

Abstract

INTRODUCTION: First-generation antihistamines taken for relief of allergic rhinitis are sedating and pose potential risks for those driving a car or operating machinery. Desloratadine is a potent, selective, histamine H(1)-receptor antagonist that does not easily cross the blood-brain barrier. It is nonsedating at therapeutic doses and should not affect driving or psychomotor performance. OBJECTIVE: This study compared the acute effects of desloratadine with diphenhydramine (active control) and placebo on the performance of healthy subjects evaluated with standard over-the-road driving tests (primary objective). The subjects' performances were also evaluated (secondary objective) with the use of conventional performance tests. METHODS: Eighteen men and women received a single dose of desloratadine 5 mg, diphenhydramine 50 mg, or placebo during each period of this randomized, double-blind, three-way, crossover study. Two hours post-dosing, subjects operated a specially instrumented vehicle in a 90-min test designed to measure their ability (1) to maintain constant speed and lateral position while following another vehicle at a constant distance and (2) to respond to brake signals. Additionally, a full battery of performance tests was administered. RESULTS: No significant differences were noted between desloratadine and placebo in standard deviation of lateral position (SDLP), whereas diphenhydramine treatment significantly increased SDLP ( P< 0.001 for both comparisons). Brake reaction time was significantly faster following treatment with desloratadine than diphenhydramine (473.72 ms vs 541.22 ms; P< 0.001) or placebo (512.06 ms; P=0.033). No differences were seen among treatments in deviation of speed or distance to the lead car. The majority of performance tests showed no significant differences among groups. CONCLUSION: Desloratadine at a therapeutic dose does not impair driving performance.

Language: en