Alzheimer’s Agitation: What Can New Drug Options Offer?

What does Auvelity offer for Alzheimer’s agitation?

Harvard Health’s guide to Alzheimer’s coping, treatment and caregiving addresses a challenge that extends beyond memory loss: managing changes in behavior while supporting daily life. That practical focus provides context for a treatment development announced earlier this year. On April 30, 2026, the FDA expanded approval of Auvelity, a combination of dextromethorphan and bupropion, to include Alzheimer’s-related agitation. [Harvard Health’s caregiving guide](https://www.health.harvard.edu/promotions/harvard-health-publications/alzheimers-disease-a-guide-to-coping-treatment-and-caregiving).

The FDA cited two randomized trials. In a five-week study, Auvelity improved scores on a caregiver-informed agitation scale more than placebo. A separate withdrawal study enrolled people who had already responded to treatment; those who continued the medicine took longer to relapse than those switched to placebo. This second design supports maintaining benefit in responders, but does not establish how every newly treated patient will respond. These findings concern agitation rather than proof of restored memory or halted Alzheimer’s progression. [FDA approval announcement](https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia).

How do Auvelity and Rexulti differ in evidence and safety?

Rexulti, the antipsychotic brexpiprazole, received FDA approval for Alzheimer’s-related agitation in 2023. Its evidence included two 12-week placebo-controlled studies that assessed changes in agitation. The medicine retains the antipsychotic boxed warning about increased mortality in older adults with dementia-related psychosis. Dizziness and sleep disturbances are also relevant when considering treatment for someone already vulnerable to falls or disrupted routines. Comparing results across separate trials cannot establish that one medicine is more effective or safer for an individual patient. [FDA assessment of Rexulti](https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-agitation-symptoms-associated-dementia-due-alzheimers-disease).

Auvelity is not an antipsychotic, but it still requires careful screening. Its prescribing information warns about seizures, increased blood pressure, dizziness and serotonin syndrome with certain interacting antidepressants. A seizure disorder is a contraindication. Clinicians should review other medicines containing dextromethorphan or bupropion and assess relevant medical history. Its boxed warning concerns suicidal thoughts and behaviors in younger patients taking antidepressants; monitoring for clinical worsening applies to all treated patients. For Alzheimer’s agitation, it is prescribed on a scheduled basis with gradual dose adjustment, rather than as an occasional rescue tablet. [Auvelity prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.pdf).

What should caregivers check before agitation medication is started?

Agitation can reflect several problems at once. The National Institute on Aging identifies pain, constipation, hunger, thirst, poor sleep, hearing or vision difficulties, medication effects and noisy surroundings as possible contributors to distressing behavior. Recording when episodes occur, what happens beforehand and what appears to help can give clinicians useful clues. A sudden or rapidly fluctuating change deserves immediate medical attention, particularly after an infection or medication change. [National Institute on Aging guidance](https://www.nia.nih.gov/es/node/20375).

Caregiver observations can also make treatment reviews more meaningful. A practical approach is to describe specific difficulties, such as distress during bathing or repeated aggressive episodes, and track whether they improve alongside any adverse effects. Addressing discomfort and reducing stressful stimulation remain part of care when a medicine is prescribed. The clinical goal should be improved comfort and safer daily functioning; a quieter person alone does not demonstrate that the underlying distress has resolved. [NIA caregiving handbook](https://order.nia.nih.gov/sites/default/files/2024-03/caring-for-a-Person-with-alzheimers-disease.pdf).