To evaluate the effectiveness and tolerability of pregabalin in the management of the discontinuation of benzodiazepines in long-term users.

We performed a 12-week, prospective, uncontrolled, non-interventional, and observational study in patients aged 18 years old or above, who met DSM-IV-TR criteria for benzodiazepine dependence without other major psychiatry disorder. Evaluations included the Benzodiazepine Withdrawal Symptom Questionnaire, the Hamilton Anxiety Rating Scale, the Clinical Global Impression Scale, and the Sheehan Disability Scale. A urine drug screen for benzodiazepines was performed at baseline and every 4 weeks thereafter. The primary effectiveness variable was success rate, defined as achievement of benzodiazepine-free status at week 12 according to the urine drug screen.

The mean dose at week 12 was 315 (±166) mg/day. The success rate of the benzodiazepine taper in the primary efficacy population (n = 282) was 52% (95% confidence interval [CI], 46–58). Success rates for women and men were 58% (95% CI, 49–67) and 46% (95% CI, 38–55), respectively. The success rates did not differ according to either the benzodiazepine of abuse or the presence of other substance use disorders. Significant and clinically relevant improvements were observed in withdrawal and anxiety symptoms, as well as in patients’ functioning. At week 12, tolerability was rated as good or excellent by 90% and 83% of the clinicians and patients, respectively.

Our results suggest that pregabalin is an efficacious and well-tolerated adjunctive treatment for benzodiazepine withdrawal.