What is the new FDA-approved medication for agitation in Alzheimer's disease?
Agitation is a common and distressing symptom in Alzheimer's disease, often treated with antipsychotics despite safety concerns. In 2024, the FDA approved Auvelity (dextromethorphan/bupropion) specifically for agitation associated with dementia due to Alzheimer's disease, marking the first FDA-approved medication for this indication 5. This approval provides a new treatment option beyond off-label use of antipsychotics.
What the research says
Auvelity is a combination of dextromethorphan (an NMDA receptor antagonist and sigma-1 receptor agonist) and bupropion (a CYP450 2D6 inhibitor that increases dextromethorphan levels) 5. The FDA approval was based on clinical trials showing efficacy in reducing agitation symptoms. Earlier research had investigated AXS-05 (the same combination) and found it generally well tolerated and potentially useful, especially for patients with comorbid depression 9. Prior to this approval, no medication was FDA-approved for Alzheimer's agitation, and antipsychotics like olanzapine were used off-label despite limited efficacy and safety concerns 11. The approval fills a significant gap in treatment options for Alzheimer's disease 59.
What to ask your doctor
- Is Auvelity appropriate for my family member's agitation symptoms?
- What are the potential side effects and drug interactions with other medications?
- How does Auvelity compare to other treatments we have tried?
- What is the dosing schedule and how long before we see improvement?
- Are there any specific monitoring requirements while on this medication?
This question is drawn from common patient questions about Neurology and answered using cited medical research. We do not provide individualized advice.