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Atypical antipsychotics have become a common pharmacologic option for the treatment of various psychiatric and behavioral symptoms in older adults, although these medications have been officially approved by the U.S. Food and Drug Administration for use only in schizophrenia and bipolar disorder. Despite the widespread use of these agents, there is a relative shortage of rigorously conducted trials. This review focuses on recently published randomized, blinded, controlled trials involving the use of atypical antipsychotics in elderly patients with dementia ( n = 9) or schizophrenia ( n = 3), with some discussion of published large, open-label studies and a few unpublished controlled trials. In general, the studies of patients with dementia reported modest efficacy of atypical antipsychotics when compared to placebo and conventional antipsychotics. In addition, an advantage in terms of motor side effects was consistently noted with atypical antipsychotics when compared to conventional antipsychotics. The studies have also shown, however, a greater risk of mortality and adverse cerebrovascular events with several of these agents than with placebo in individuals with dementia. There are insufficient data comparing atypical antipsychotics to one another. In the trials involving elderly persons with schizophrenia, atypical antipsychotics were associated with significant improvements in psychopathology; differences in efficacy among atypical antipsychotics were unclear. A careful consideration of the risk-benefit ratio of atypical antipsychotics, as well as that of available alternative treatments, is needed for each individual elderly patient. Clinical judgment, caution, and consent should be the watchwords in this area of psychopharmacology. [ABSTRACT FROM AUTHOR]