Efficacy and safety of pregabalin in the treatment of alcohol and benzodiazepine dependence

Expert Opin Investig Drugs. 2012 Jul;21(7):1019-29. doi: 10.1517/13543784.2012.685651. Epub 2012 May 9.


Introduction: Both alcohol and benzodiazepine dependence (AD, BD) are severe and chronic conditions with devastating physical and mental health effects. The relative scarcity and controversial evidential status of available pharmacological interventions for the treatment of patients' acute withdrawal syndrome and/or relapse prevention call for the clinical investigation of novel safe and efficacious agents.

Areas covered: We review published studies of pregabalin as monotherapy in the treatment of AD and BD in more than 450 patients. Available evidence includes four RCTs, two in AD with active comparator drugs (naltrexone, tiapride, and lorazepam) and one placebo-controlled, and one placebo-controlled in BD. We also review other available studies on pregabalin's potential to reduce benzodiazepine consumption, its side effects, especially cognitive, as well as extant reports on its liability for abuse.

Expert opinion: Available evidence suggests that monotherapy with pregabalin, within the dosage range of 150 - 600 mg/d, is a promising "novel" option for the safe and efficacious relapse prevention of both AD and BD. However, its efficacy as monotherapy in the acute treatment of AD withdrawal syndrome is still controversial. Clinicians should be cautious in prescribing pregabalin to patients with a history of multiple substance recreational use, and monitor its effects on cognition at dosages above 450 mg/d. Further, well-designed clinical research is still needed for the eventual consolidation of pregabalin's place in the treatment of AD and BD.

Publication types

  • Review

MeSH terms

  • Alcoholism / drug therapy*
  • Animals
  • Benzodiazepines / adverse effects*
  • Clinical Trials as Topic
  • Humans
  • Molecular Structure
  • Pregabalin
  • Secondary Prevention
  • Substance Withdrawal Syndrome / drug therapy*
  • Substance Withdrawal Syndrome / etiology
  • Treatment Outcome
  • gamma-Aminobutyric Acid / adverse effects
  • gamma-Aminobutyric Acid / analogs & derivatives*
  • gamma-Aminobutyric Acid / pharmacokinetics
  • gamma-Aminobutyric Acid / therapeutic use


  • Benzodiazepines
  • Pregabalin
  • gamma-Aminobutyric Acid