Double-Blind Crossover Study of the Efficacy and Acceptability of Oxazepam Expidet® Tablets Compared to Placebo in Patients Undergoing Gynaecological Surgery

Abstract

In a double-blind crossover trial, the hypnotic efficacy and acceptability of oxazepam Expidet®, a fast-dissolving tablet, was compared to placebo in patients undergoing minor gynaecological surgery. Patients received 30 mg oxazepam Expidet® or placebo the night before their operation and the alternate medication the night after. A sleep questionnaire was completed the morning after both nights and acceptability was assessed the morning after the second night. Data were available for analysis on seventy-two patients aged 18–50 years. There was a significant improvement In sleep onset and quality and less awakenings after oxazepam compared to placebo (p ≤ 0·01). There was no significant difference in the occurrence or type of dreams, or morning-after symptoms. There was a significant preference for oxazepam compared to placebo and for the fast-dissolving Expidet® form compared to conventional tablets or capsules (p ≤ 0·01). There were no adverse reactions in the oxazepam group. It was concluded that oxazepam Expidet® was an effective and acceptable hypnotic in this group of patients.