FDA Approves First Non-Antipsychotic Drug for Alzheimer's Agitation

— Oral NMDA receptor antagonist gets an expanded indication by Judy George, Deputy Managing Editor, MedPage Today May 1, 2026 • 2 min read The FDA expanded the indication for dextromethorphan hydrobromide and bupropion hydrochloride (Auvelity) extended-release tablets to treat agitation associated with Alzheimer's disease dementia, the agency announced Thursday. This decision marks the first approved treatment for Alzheimer's dementia that is not an antipsychotic, the FDA said. The drug initially was approved to treat major depressive disorder in 2022. "This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease," said FDA Commissioner Marty Makary, MD, MPH. Agitation is common in people with Alzheimer's dementia and can include excessive motor activity or verbal or physical aggression, affecting patients' and caregivers' quality of life, the agency noted. "For too long, people living with Alzheimer's disease agitation and their families have had limited options, and the options that existed came with significant risks," Joanne Pike, DrPH, president and CEO of the Alzheimer's Association, said in a statement. "This approval gives patients, caregivers, and clinicians an important new tool -- one that works through a different mechanism than