To evaluate the effect of pregabalin as a tapering therapy over the subjective sleep quality of patients who underwent a benzodiazepine withdrawal program.

This was a secondary analysis of a 12-week, prospective, and observational study carried out in patients aged 18 years or over, 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 MOS-Sleep Scale. Changes from baseline to the endpoint in the different scales’ scores as well as correlations of these changes with those of the MOS-Sleep scores were calculated.

282 patients met the criteria for analysis. Mean pregabalin dose was 315 (166) mg/day at end-of-trial. We observed a significant and clinically relevant improvement in sleep outcomes at the study endpoint as measured with the MOS-Sleep Summary Index, that was reduced from 55.8 (18.9) pts at baseline to 25.1 (18.0) pts at week 12 (55% reduction), as well as with the six dimensions of the MOS-Sleep Scale. Moderate correlations were observed between Summary Index and sleep domains with improvements in the anxiety symptoms and in the disease severity as well. Also, sleep ameliorations were observed in the 52% successfully benzodiazepines withdrawals but, although to a lesser extent, in the remaining failures as well.

Pregabalin treatment improves subjective sleep quality in patients who underwent a benzodiazepine withdrawal program and this effect appears partly independent of the improvement of anxiety or withdrawal symptoms.