Efficacy of quetiapine off-label uses: data synthesis

Quetiapine (Seroquel(®)) is a potent U.S. Food and Drug Administration (FDA)-approved antipsychotic agent that has been used extensively for off-label indications. The current study was performed to ascertain the efficacy of some of the most prevalent off-label uses of this agent. An extensive search of electronic databases was completed using the search terms quetiapine or Seroquel, off-label and anxiety, substance abuse, dementia, delirium, personality disorder, insomnia, and sleep. Data were predictably mixed according to the indication being examined. The strongest evidence exists for anxiety and delirium. Moderate evidence exists for quetiapine as a pharmacological intervention for insomnia, dementia, and specific personality disorders. Evidence for quetiapine as a treatment for substance abuse is limited. More data are needed to establish specific dosing regimens for off-label uses and to examine the dose relationship to metabolic side effects and extrapyramidal side effects to determine whether various off-label uses justify the risk incurred with using this powerful drug.