A RANDOMIZED, DOUBLE-BLIND-STUDY OF ALPIDEM VS PLACEBO IN THE PREVENTION AND TREATMENT OF BENZODIAZEPINE WITHDRAWAL SYNDROME

The aim of the trial was to assess alpidem efficacy in preventing and treating the benzodiazepine (BZ) withdrawal syndrome (WS). A multicent re, double-blind, randomized versus placebo, parallel group study of s ix-week duration was carried out in outpatients suffering from general ized anxiety or adjustment disorder with an anxious mood and taking no n-hypnotic BZ as continuous course of therapy of at least one-year dur ation. At the entry, the patients abruptly discontinued BZs and were t reated with 50 mg/bid/tid of alpidem or placebo. Withdrawal syndrome d iagnosis was (regarding treatment allocation) formulated by an indepen dent psychiatrist, according to DSM-III-R and an appropriate scale, th e SESSB. One hundred seventy-three patients were randomized and 148 co mpleted 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 gro up and in 31.6% of the placebo group. If not having been withdrawn fro m the market, alpidem could have been useful for the prevention of BZ withdrawal syndrome.