Aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone are atypical antipsychotics approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia and bipolar disorder. These drugs have been studied for off-label use in the following conditions: dementia and severe geriatric agitation, depression, obsessive-compulsive disorder, posttraumatic stress disorder, and personality disorders. The atypicals have also been studied for the management of Tourette-s syndrome and autism in children.

The purpose of this report is to review the scientific evidence on the safety and effectiveness of such off-label uses.

The Key Questions were: 1. What are the leading off-label uses of atypical antipsychotics in the literature? 2. What does the evidence show regarding the effectiveness of atypical antipsychotics for off-label indications, such as depression? How do atypical antipsychotic medications compare with other drugs for treating off-label indications? 3. What subset of the population would potentially benefit from off-label uses? 4. What are the potential adverse effects and/or complications involved with off-label prescribing of atypical antipsychotics? 5. What are the appropriate dose and time limit for off-label indications?