Longevity & AgingFDA Approves First Non-Antipsychotic Drug to Treat Alzheimer's Agitation
The FDA has approved Auvelity (dextromethorphan/bupropion) as the first non-antipsychotic treatment for agitation in Alzheimer's dementia. Previously approved for depression in 2022, the drug works by targeting NMDA and sigma-1 receptors in the brain. Agitation — which includes excessive movement, verbal outbursts, and physical aggression — is one of the most distressing symptoms for both patients and caregivers. Two randomized clinical trials demonstrated the drug's effectiveness: the ADVANCE trial showed significant improvements in agitation scores versus placebo, and the ACCORD-2 withdrawal study confirmed sustained benefit. Side effects include dizziness, nausea, and elevated blood pressure, with a boxed warning for suicidal thoughts in younger users. This approval marks a meaningful shift in how Alzheimer's behavioral symptoms can be managed.
