ALPIDEM - LACK OF SEDATIVE EFFECT ON PSYCHOMOTOR PERFORMANCE IN THERAPEUTIC DOSES

This is a randomised, double blind, cross-over, placebo-controlled stu dy carried out in 12 healthy young male volunteers. It consisted of si x test days separated by two week wash-out periods. The objective was to compare the potential sedative effects of 3 single oral doses of al pidem (50 mg, 100 mg and 200 mg) versus diazepam (10 mg and 15 mg). Ph armacodynamics were assessed by objective psychometric tests (critical flicker fusion, choice-reaction time, manual dexterity, digit span) a nd subjective evaluation (visual analogue scales) before then 2 h, 4 h , 8 h and 24 h post-dose. Alpidem in dosages of 50 mg and 100 mg did n ot impair alertness or psychomotor performance; with 200 mg, psychomet ric tests and visual analogue scales demonstrated sedative effects 2 h post-dose. In contrast, diazepam in a therapeutic dosage (IO and 15 m g) produced similar impairments of vigilance and psychomotor performan ce as alpidem 200 mg, indicating a lack of dissociation between anxiol ytic and sedative effects.