title: Effects of azatadine maleate on subjective appraisal and psychomotor functions relevant to driving performance.
abstract: Studies were carried out in normal healthy male subjects to assess the effects on psychomotor functions and subjective ratings of performance after acute administration of azatadine maleate, a potent antihistamine with additional antiserotonin activity. In the first trial, 2 mg azatadine was compared with another new antihistamine Sch 12169 (2 mg) and placebo. In a second trial, higher doses of azatadine (4 mg and 8 mg) were compared with dexchlorpheniramine (4 mg) and placebo. Both trials were of a double-blind, randomized Latin square design and subjects were assessed using a battery of tests, after administration of each trial drug. The time and sequence of tests were standarized, with a 1-week interval between test sessions. The results showed that azatadine did not produce significant impairment of psychomotor function at either the standard 2 mg or the maximum recommended 4 mg per day dosage level. Permormance was only significantly impaired, compared with that after placebo, at the 8 mg dose level and was of a similar order to that observed after dexchlorpheniramine at the usual 4 mg dosage. It is suggested, therefore, that at the normal recommended dosage of 2 mg per day, azatadine is not likely to impair driving ability.
mesh_terms: D000293:Adolescent; D000328:Adult; D001334:Automobile Driving; D003533:Cyproheptadine / Q000031:analogs & derivatives* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006634:Histamine H1 Antagonists / Q000494:pharmacology*; D006801:Humans; D008297:Male; D009048:Motor Skills / Q000187:drug effects*
chemical_list: D006634:Histamine H1 Antagonists; D003533:Cyproheptadine