FDA Alert

FDA Approves Auvelity for Agitation in Alzheimer Disease Dementia

Edited by:
Anthony Calabro, MA

Key Highlights

  • Auvelity is the first non-antipsychotic FDA-approved therapy for agitation in Alzheimer dementia
  • Approval was supported by 2 randomized trials demonstrating efficacy on agitation measures and relapse prevention
  • Common adverse events include dizziness, headache, diarrhea, and somnolence
  • The drug carries a boxed warning for increased risk of suicidal thoughts and behaviors in younger populations

On April 30, the FDA approved an expanded indication for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets for the treatment of agitation associated with dementia due to Alzheimer disease in adults. Dextromethorphan-bupropion is the first FDA-approved therapy for this indication that is not an antipsychotic. The agent was previously approved in 2022 for major depressive disorder in adults.

Findings from 2 randomized clinical trials supported the approval. In a 5-week, placebo-controlled study (NCT 03226522), patients receiving dextromethorphan-bupropion demonstrated statistically significant improvements from baseline in Cohen-Mansfield Agitation Inventory scores compared with placebo. A second randomized withdrawal trial (NCT 04947553) evaluated time to relapse among patients who achieved sustained response; those continuing dextromethorphan-bupropion experienced a significantly longer time to relapse of agitation symptoms than those switched to placebo.

“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,” Marty Makary, MD, MPH, FDA commissioner, said in a press release.

The most common adverse events associated with dextromethorphan-bupropion include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and hyperhidrosis. The drug carries a boxed warning for increased risk of suicidal thoughts and behaviors in adolescents and young adults taking antidepressants. Additional risks include seizures, elevated blood pressure, hypertension, and activation of mania or hypomania.

Clinicians are advised to assess blood pressure, evaluate for bipolar disorder, and review concomitant medications prior to initiating therapy. Specific dosing and duration recommendations were not detailed in the FDA announcement.

Reference
U.S. Food and Drug Administration. FDA approves first non-antipsychotic drug to treat agitation associated with dementia. April 30, 2026. Accessed May 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia