Volume 205, Number 4, 679-688, DOI: 10.1007/s00213-009-1576-6

Lack of sedative effects after vespertine intake of oxazepam as hypnotic in healthy volunteers

Barbara Wilhelm, Renate Kellert, Rainer Schnell, Holger Lüdtke and Orlando Petrini

View Related Documents

Abstract

Aims  

An objective physiological test was used to investigate the hangover effect, its time course and dose relationship compared to placebo and an herbal relaxant.

Methods  

Pupillographic Sleepiness Test as an objective measurement, Stanford Sleepiness Scale (SSS) and visual analogue scales (VAS) were used. Study design included: (a) randomised, double-blind, double-dummy, placebo-controlled crossover trial; (b) double-blind, placebo-controlled, randomised study. Primary end point was the Pupillary Unrest Index (lnPUI).

Results  

Oxazepam 10 mg did not increase PUI. In the VAS and SSS, there was no increase in sleepiness after the three treatment periods. Neither 10 nor 30 mg oxazepam caused sedation in healthy volunteers. Subjective and objective sleepiness measures correlated significantly.

Discussion  

The lack of sedative effects after vespertine intake of oxazepam (10/30 mg) seems to be relevant with respect to product safety. With regard to the subjective perception at 30 mg, fatigue rather than sleepiness may be the underlying reason.

Keywords  Pupillary oscillations - Pupillographic sleepiness test (PST) - Hangover oxazepam

Declaration addressing ethical standards  All experiments documented in this manuscript complied with the current laws of Germany.

Fulltext Preview

Image of the first page of the fulltext document