OBJECTIVES:  Most patients with dementia also suffer from Behavioral and Psychological Symptoms of Dementia (BPSD).  BPSD is a major reason for accelerated cognitive decline and poor functioning in dementia patients, institutionalization, and increased caregiver distress, and hence poses a significant quality-of-life and economic burden on patients and their families.  There is currently no FDA-approved treatment for BPSD.  Our objectives were: To determine (1)whether the FDA’s Black Box warning in April 2005 has led to a decline in off-label prescriptions of atypical antipsychotics for BPSD as well as (2) whether prescriptions for other psychotropic drugs, including acetylcholinesterase inhibitors (ACIs), antidepressants, anxiolytics, and antiepileptics have increased. METHODS:   Data were obtained and combined from two large national surveys:  the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. Visits of elderly ( > 65) patients with dementia were identified using the International Classification of Disease, 9th Revision, Clinical Modification (ICD-9 CM) codes for dementia.  Excluded were the visits for which the patient had a diagnosis of schizophrenia or bipolar disorder.  Percentage drug utilization statistics were calculated. RESULTS:   The percentage of visits mentioning an atypical antipsychotic decreased from 12.5% pre-warning to 11.5% post-warning. The percent utilization of ACIs, antidepressants, and anxiolytics has fallen, while the use of antiepileptics has remained the same since the FDA’s warning.  Post-warning, 34.4% of patients were taking none of the study medications, as opposed to 26.1% pre-warning. In 2005, the year of the warning, 44.6% of visits had no study-drug mention.  CONCLUSIONS: Our findings suggest that the FDA’s April 2005 Black Box warning had just a small negative impact on the use of atypical antipsychotics. There is no evidence of substitution of other psychotropic medications for the atypicals. What are needed are FDA-approved drugs for BPSD so that prescriber choices can expand beyond off-label options.