A comparative study of alpidem, a nonbenzodiazepine, and lorazepam in patients with nonpsychotic anxiety.

The use of benzodiazepines for generalized anxiety disorder (GAD) is a safe and effective treatment; however, their potential to produce dependence and impair psychomotor and cognitive functions is a drawback. In this study the efficacy and safety of alpidem, a nonbenzodiazepine, was assessed. Thirty patients who met DSM-III-R criteria for GAD were randomized to either alpidem (225 mg), lorazepam (4.5 mg), or placebo. The primary efficacy measure was the Hamilton Rating Scale for Anxiety (HAM-A). A repeated measures multivariate analysis of variance (MANOVA) was used to determine differences in HAM-A scores over time. The results showed a trend for alpidem to be more effective. Half of the alpidem group had a decrease of 50 percent or greater in their HAM-A scores with an almost equal effect on psychic and somatic symptoms. The most common side effects with alpidem and lorazepam were lightheadedness, drowsiness, and daytime tiredness. Moreover, treatment with alpidem did not manifest any withdrawal symptoms. Thus nonbenzodiazepine treatments are effective and safe for GAD.

RCT Entities:   Population Interventions Outcomes