FDA Approves Repurposed Anti-Depressant to Treat Alzheimer's-Associated Agitation

Auvelity, developed by Axsome Therapeutics, was approved today by the U.S. Food & Drug Administration (FDA) for the treatment of Alzheimer’s disease agitation, a common and challenging symptom that affects 40 to 60 percent of people living with Alzheimer’s disease.

In January 2026, the FDA granted priority review for Auvelity, significantly shortening the review process.

In Phase II/III trials, participants who received Auvelity showed meaningful reductions in agitation score – in as soon as one to two weeks compared to those who received a placebo. The drug was well-tolerated and did not lead to any worsening of cognition, which is a key concern for sedatives and a major drawback for the first medication approved to treat Alzheimer’s-associated agitation.

“Alzheimer’s-associated agitation is one of the most troubling and challenging side effects for people living with the disease, their families, and their caregivers,” said BrightFocus President and CEO Stacy Pagos Haller. “This decision provides a tool to help address an important unmet need in the Alzheimer’s community.”

Auvelity is a combination of two medications, dextromethorphan and bupropion, and had been approved previously by the FDA for the treatment of major depressive disorder. These two drugs affect brain pathways responsible for mood regulation and stress responses, two networks thought to be involved in the agitation-related behavioral changes associated with dementia.

Agitation resulting from Alzheimer’s can include symptoms such as restlessness, irritability, pacing, yelling, and even aggression towards family and caregivers. In some cases, these symptoms appear at the end of the day, a phenomenon known as sundowning.

More than just a set of difficult-to-manage symptoms, agitation is one of the leading causes of nursing home placement. The ability to effectively manage agitation symptoms could impact whether someone with Alzheimer’s was able to safely remain at home and represent a significant improvement on quality of life and safety for them and their caregivers.

See a full list of FDA-approved Alzheimer’s therapies.