title: Effects of mizolastine and clemastine on actual driving and psychomotor performance in healthy volunteers.
abstract: The acute effect of doses of mizolastine 5, 10, 20 and 40 mg, an active control (clemastine 2 mg) and placebo on actual car driving and psychomotor performance have been compared. Twenty four healthy volunteers were treated according to a double-blind, 6-way cross-over design. In the driving test, lasting about 1 h, lateral position control and speed were continuously measured; the psychomotor test battery, lasting 50 min, comprised critical flicker-fusion frequency, critical instability tracking, divided attention, memory search and choice reaction time, and vigilance studies; and mood changes and possible adverse-effects were rated on visual analogue scales. The results showed a dose-response relationship: mizolastine 40 and 20 mg impaired driving and psychomotor performance. The effect of mizolastine 40 mg on driving was strongly correlated with that of clemastine (r = 0.78) and was comparable to the effect of a blood ethanol level of 0.8 mg.ml-1. Mizolastine 5 mg and 10 mg did not have a significant effect on driving performance and psychomotor tests. It was concluded that at a 10 mg dose of mizolastine, the therapeutic dose, it could be considered a safe anti-histamine, although individual adverse reactions cannot be completely ruled out.
authors.affiliation: Institute for Human Psychopharmacology, Maastricht, The Netherlands.
authors.forename: E F
authors.initials: EF
authors.lastname: Vuurman
authors.forename: M M
authors.initials: MM
authors.lastname: Uiterwijk
authors.forename: P
authors.initials: P
authors.lastname: Rosenzweig
authors.forename: J F
authors.initials: JF
authors.lastname: O'Hanlon
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D001334:Automobile Driving; D001519:Behavior / Q000187:drug effects; D001562:Benzimidazoles / Q000009:adverse effects / Q000494:pharmacology*; D002974:Clemastine / Q000009:adverse effects / Q000494:pharmacology*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D008297:Male; D011594:Psychometrics; D011597:Psychomotor Performance / Q000187:drug effects*; D011930:Reaction Time / Q000187:drug effects; D012680:Sensitivity and Specificity
chemical_list: D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; C076170:mizolastine; D002974:Clemastine