A randomized, double-blind study of alpidem vs placebo in the prevention and treatment of benzodiazepine withdrawal syndrome

Abstract

SummaryThe aim of the trial was to assess alpidem efficacy in preventing and treating the benzodiazepine (BZ) withdrawal syndrome (WS). A multicentre, double-blind, randomized versus placebo, parallel group study of six-week duration was carried out in outpatients suffering from generalized anxiety or adjustment disorder with an anxious mood and taking non-hypnotic BZ as continuous course of therapy of at least one-year duration. At the entry, the patients abruptly discontinued BZs and were treated with 50 mg/bid/tid of alpidem or placebo. Withdrawal syndrome diagnosis was (regarding treatment allocation) formulated by an independent psychiatrist, according to DSM-III-R and an appropriate scale, the SESSB. One hundred seventy-three patients were randomized and 148 completed the study. Withdrawal syndrome occurred in 27 patients of the alpidem group (31.0%) and in 38 patients of the placebo group (44.2%). A severe WS was diagnosed in 11.1% of the patients in the alpidem group and in 31.6% of the placebo group. If not having been withdrawn from the market, alpidem could have been useful for the prevention of BZ withdrawal syndrome.