The Use of Risperidone in Behavioral and Psychological Symptoms of Dementia: A Review of Pharmacology, Clinical Evidence, Regulatory Approvals, and Off-Label Use

Dementia represents a global health challenge due to the increase in elderly population worldwide. In addition to memory loss, dementia often results in severe behavioral and psychological changes where pharmacological treatments might be considered in addition to nonpharmacological strategies for optimal symptomatic control. Risperidone, the second oldest atypical antipsychotic, has been widely used off-label to treat behavioral and psychological symptoms of dementia (BPSD), including agitation, aggression, and psychosis. Several studies have indicated that risperidone offers a modest and statistically significant effectiveness in the clinical setting. However, in the past decade, safety concerns emerged due to increased risk for cerebrovascular adverse events and death following the use of risperidone in the elderly population. Clinical guidelines suggest that, in severe dementia where an older adult is threatening to harm himself or others, pharmacological treatments might be considered when nonpharmacological treatments fail. Risperidone was approved for BPSD in some countries (Australia, Canada, United Kingdom and New Zealand) but not in the United States. This article reviews risperidone’s pharmacological activity, clinical effectiveness and safety, marketing approval, and off-label use in BPSD.