DIET & NUTRITION 
PATIENT EDUCATION 
OBESITY/WEIGHT MANAGEMENT 
EXERCISE/TRAINING 
LEGAL MATTERS 
GUIDELINES/RECOMMENDATIONS 📋 Regulatory Action / Label Change
The FDA approved dextromethorphan-bupropion (Auvelity) for agitation associated with dementia due to Alzheimer’s disease, an indication previously without an approved oral therapy specific to this population. Agitation affects up to 76% of patients with Alzheimer’s, which affects more than 7 million Americans.
Professional Impact
- ADVANCE-1 phase 3 trial showed statistically significant improvement in Cohen-Mansfield Agitation Inventory scores versus placebo at week 5.
- ACCORD-2 withdrawal trial demonstrated longer time to relapse in continued-treatment patients, though enrollment of known responders shapes interpretation.
- Approval carries a boxed warning for suicidal thoughts and behaviors, plus risks of seizures, hypertension, falls, hyponatremia, and serotonin syndrome.
- Bupropion’s CYP2D6 inhibition may alter metabolism of co-prescribed drugs; MAOIs are contraindicated.
Action Items
- Review full prescribing information before initiating, particularly drug interactions.
- Monitor older adults for hyponatremia, falls, and blood pressure changes.
- Document the dementia-specific titration (30/105 mg daily, then twice daily, then 45/105 mg twice daily).
- Avoid as-needed dosing; this is not approved for PRN use.
