What Happened

Dextromethorphan-bupropion (Auvelity) received FDA approval on April 30, 2026, for the treatment of agitation associated with Alzheimer’s disease. This marks a significant development as it is the first non-antipsychotic medication approved for this indication, providing a new treatment option for patients experiencing agitation due to dementia. Auvelity combines dextromethorphan, an NMDA receptor antagonist, with bupropion, a well-known antidepressant, to address this challenging symptom in Alzheimer’s patients.

Why It Matters

Agitation is a common and distressing symptom in Alzheimer's disease, affecting up to 70% of patients at some point during their illness. Traditional management often relies on antipsychotic medications, which carry risks of serious side effects, including increased mortality in elderly patients with dementia. The approval of Auvelity offers a new approach that may reduce reliance on these high-risk medications. This change is particularly relevant as the healthcare community seeks safer alternatives to manage agitation, which can lead to increased caregiver burden and institutionalization of patients. The timing of this approval aligns with growing concerns about the overuse of antipsychotics in this vulnerable population, making Auvelity a timely addition to treatment options.

What Changed

Auvelity is now approved specifically for treating agitation associated with Alzheimer’s disease, a first for non-antipsychotic agents [1].
The recommended starting dosage for agitation is 30 mg/105 mg once daily, increasing to 45 mg/105 mg twice daily based on tolerability [1].
Clinicians should consult current prescribing information for full dosing guidance.
Patients must be screened for a history of bipolar disorder, mania, or hypomania before initiating treatment [1].
Unlike traditional antipsychotics, Auvelity is not indicated for as-needed use, emphasizing the need for a consistent treatment approach [1].
The approval supports a shift towards non-antipsychotic therapies in managing agitation, which may improve patient safety and outcomes [2].

What This Means for Your Practice

Clinicians managing patients with Alzheimer’s disease should consider Auvelity as a new treatment option for agitation, particularly in cases where traditional antipsychotics are deemed inappropriate due to their side effect profiles. Primary care providers and neurologists should assess patients for agitation and consider initiating Auvelity at the recommended starting dose, monitoring for efficacy and tolerability. This approval may also prompt a reevaluation of current treatment protocols, encouraging a broader use of non-antipsychotic therapies in dementia care. How will this new option influence your prescribing practices, particularly in patients with a history of adverse reactions to antipsychotics?

Sources and Further Reading

[1] DailyMed. AUVELITY- dextromethorphan hydrobromide, bupropion hydrochloride tablet, multilayer, extended release. Updated May 6, 2026. URL: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dcefda7c-9a68-278e-e053-2995a90aec79

[2] Imbimbo C, et al. Emerging Pharmacological Approaches for Psychosis and Agitation in Alzheimer’s Disease. PMC. 2024 Dec 2. URL: https://pmc.ncbi.nlm.nih.gov/articles/PMC11769872/

What Happened

Why It Matters

What Changed

What This Means for Your Practice

Sources and Further Reading

References

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Auvelity Approved for Alzheimer Agitation: First Non-Antipsychotic Option