Brexpiprazole, the atypical antipsychotic, has been accorded US FDA approval for the treatment of agitation associated with Alzheimers disease dementia.¹ The drug is available as oral tablets and is already approved for use in schizophrenia in adults and children aged 13 years and older and major depressive disorder in adults. However, it is not approved for the treatment of patients with dementia-related psychosis.

Management of agitation in persons with Alzheimer’s disease is challenging. Symptoms of agitation include restlessness, pacing back and forth and even aggression, both physical and verbal.

Dose: The starting dose is 0.5 mg once daily for the first week; increase to 1 mg once daily for the next week and to 2 mg once daily on day 15. The maximum daily dose is 3 mg, which can be given after a minimum of 14 days depending upon clinical response and tolerability.

Side effects: Headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (somnolence and insomnia)

Warning: Brexpiprazole carries a Boxed Warning about risk of increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors

Reference

1. FDA news release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-agitation-symptoms-associated-dementia-due-alzheimers-disease. May 11, 2023. Accessed on May 12, 2023.