title: Lack of effects between rupatadine 10 mg and placebo on actual driving performance of healthy volunteers.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  Rupatadine 10 mg is not sedating and does not impair driving performance.
authors.affiliation: Brain and Behaviour Institute, Faculty of Medicine, Maastricht University, The Netherlands. e.vuurman@np.unimaas.nl
authors.forename: Eric
authors.initials: E
authors.lastname: Vuurman
authors.forename: Eef
authors.initials: E
authors.lastname: Theunissen
authors.forename: Anita
authors.initials: A
authors.lastname: van Oers
authors.forename: Cees
authors.initials: C
authors.lastname: van Leeuwen
authors.forename: Jelle
authors.initials: J
authors.lastname: Jolles
mesh_terms: D000328:Adult; D001334:Automobile Driving; D018592:Cross-Over Studies; D003533:Cyproheptadine / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D006919:Hydroxyzine / Q000009:adverse effects; D008297:Male; D008875:Middle Aged
chemical_list: D006634:Histamine H1 Antagonists; C103639:rupatadine; D003533:Cyproheptadine; D006919:Hydroxyzine