Pharmacodynamics

European Journal of Clinical Pharmacology

, Volume 60, Issue 5, pp 307-313

Effects of desloratadine, diphenhydramine, and placebo on driving performance and psychomotor performance measurements

  • E. F. P. M. VuurmanAffiliated withExperimental Psychopharmacology Unit, Department of Psychiatry and Neuropsychology Email author 
  • , G. H. RikkenAffiliated withSchering-Plough Research Institute
  • , N. D. MuntjewerffAffiliated withExperimental Psychopharmacology Unit, Department of Psychiatry and Neuropsychology
  • , F. de HalleuxAffiliated withSchering-Plough Research Institute
  • , J. G. RamaekersAffiliated withExperimental Psychopharmacology Unit, Department of Psychiatry and Neuropsychology

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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 H1-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.

Keywords

Antihistamine Desloratadine Diphenhydramine