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# 1st Non-Antipsychotic OK’d for Agitation in Alzheimer’s Patients
- URL: https://www.fdaweb.com/1st-non-antipsychotic-okd-for-agitation-in-alzheimers-patients/
- Published: 2026-04-30T12:00:00.000Z
- Updated: 2026-09-14T13:38:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161074

FDA has approved an expanded use for Axsome Therapeutics’s Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associated with dementia due to Alzheimer’s disease.

The decision broadens the label for the drug, which was originally approved in 2022 for major depressive disorder, and provides a new treatment option for a common and often debilitating symptom of Alzheimer’s. Agitation in these patients can include aggression, restlessness, and distressing behavioral changes that significantly affect both patients and caregivers, according to an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia?ref=fdaweb.com).

The agency says the approval represents a meaningful step forward in addressing a major unmet need. The agency cited evidence from two randomized clinical trials demonstrating that Auvelity significantly reduced agitation symptoms compared with placebo and helped sustain symptom control over time. In one five-week study, patients receiving Auvelity showed greater improvements on a standardized measure of agitation, the Cohen-Mansfield Agitation Inventory. A second withdrawal trial found that patients who continued treatment experienced a longer time to relapse compared with those switched to placebo, it says.

The drug’s safety profile is consistent with its known effects, with common side effects including dizziness, gastrointestinal issues, headache, drowsiness, and dry mouth. Auvelity also carries a Boxed Warning for increased risk of suicidal thoughts and behaviors in younger patients taking antidepressants, along with risks of seizures, elevated blood pressure, and potential activation of mania in susceptible individuals.