Alpidem: Lack of sedative effect on psychomotor performance in therapeutic doses

✍ Scribed by P. Rosenzweig; S. Warrington; A. Patat; V. Ascalone; L. Bergougnan; P. L. Morselli

• Publisher: John Wiley and Sons
• Year: 1993
• Tongue: English
• Volume: 8
• Category: Article
• ISSN: 0885-6222
• DOI: 10.1002/hup.470080606

✦ Synopsis

This is a randomised, double blind, cross-over, placebo-controlled study carried out in 12 healthy young male volunteers. It consisted of six test days separated by two week wash-out periods. The objective was to compare the potential sedative effects of 3 single oral doses of alpidem (50 mg, 100 mg and 200 mg) versus diazepam (10 mg and 15 mg). Pharmacodynamics were assessed by objective psychometric tests (critical flicker fusion, choice-reaction time, manual dexterity, digit span) and 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 not impair alertness or psychomotor performance; with 200 mg, psychometric tests and visual analogue scales demonstrated sedative effects 2 h post-dose.

In contrast, diazepam in a therapeutic dosage (10 and 15 mg) produced similar impairments of vigilance and psychomotor performance as alpidem 200 mg, indicating a lack of dissociation between anxiolytic and sedative effects.