Brexpiprazole: A Balance of Risks and Benefits.

Alzheimer's disease is the most common cause of dementia. Behavioral and psychological symptoms in dementia (BPSD) are neuropsychiatric signs accompanying dementia that carry a significant impact on prognosis and management. Management of BPSD is challenging because of its complex and multifactorial nature. Historically, no medications were specifically approved for the treatment of BPSD, and any pharmacological use was considered off-label. In May 2023, brexpiprazole was the first and only atypical antipsychotic agent to receive US Food and Drug Administration approval for the treatment of agitation associated with dementia because of Alzheimer's disease. The purposes of this article are to discuss the clinical characteristics of brexpiprazole with a focus on safety and efficacy in older adults, to review the studies that led to the approval for agitation associated with dementia, and to examine its potential place in therapy and impact on patient care. Brexpiprazole is a second-generation antipsychotic with affinity for multiple monoaminergic receptors. Efficacy, safety, and tolerability of brexpiprazole for the treatment of agitation associated with dementia because of Alzheimer's disease was evaluated in two Phase III studies with results suggesting that brexpiprazole has potential to be a safe, effective, and well-tolerated treatment for this indication. Given the individualized and complicated nature of BPSD, brexpiprazole is another option in the treatment landscape that may improve symptoms of agitation but requires careful assessment to ensure benefits outweigh any risks.