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Donate NowAlzheimer’s Association Welcomes FDA Approval of First Non-Antipsychotic Treatment for Alzheimer’s Disease Agitation
Alzheimer’s and dementia are more than memory loss. Agitation associated with Alzheimer’s can include restlessness, emotional distress, and physical or verbal aggression. It is one of the hardest symptoms to manage and takes a serious toll on people living with the disease and the families who support them.
“For too long, people living with Alzheimer’s disease agitation and their families have had limited options, and the options that existed came with significant risks,” said Joanne Pike, Dr.P.H., president and chief executive officer of the Alzheimer’s Association. “This approval gives patients, caregivers and clinicians an important new tool — one that works through a different mechanism than antipsychotic medications and that can help address a symptom that profoundly affects quality of life for people living with Alzheimer’s and those who care for them.”
AXS-05 is the first FDA-approved treatment specifically indicated for Alzheimer’s disease agitation that is not classified as an antipsychotic. In clinical trials, the treatment substantially reduced the risk of relapse of agitation compared with bupropion alone and placebo, and showed a favorable long-term safety profile through 12 months, with no observed increase in fall risk, cognitive decline, or sedation. The Association encourages patients, caregivers and clinicians to carefully review the prescribing information and engage in shared decision-making when considering this treatment.
The Alzheimer’s Association has long advocated for a careful, individualized approach to managing behavioral and psychological symptoms of dementia. Non-pharmacological strategies — including environmental modifications, structured routines, and psychosocial interventions — are recommended as a first-line approach.
Until recently, people living with Alzheimer’s disease had only one FDA-approved medication with a primary indication for agitation. Today’s decision expands those options with a new type of treatment that addresses longstanding concerns about the safety and tolerability of antipsychotics in this population — giving clinicians and families more tools to address one of the disease's most challenging symptoms.
Approval of the new indication for AXS-05 also reflects an important model of innovation. The medication, already approved for major depressive disorder, combines two previously approved medications: dextromethorphan, long used as a cough suppressant, and bupropion, widely prescribed for depression and smoking cessation. Researchers found that together, these drugs act on brain pathways relevant to agitation in ways neither achieves alone. It is a reminder that advancing treatment for Alzheimer’s disease does not always require building from scratch, but can come from a deeper understanding of how existing medicines can address the unmet needs of people living with the disease.
The Alzheimer’s Association is committed to ensuring newly approved treatments are accessible to all who may benefit. We will advocate for equitable coverage by Medicare, Medicaid and private payers to ensure this treatment is accessible to all who need it. For questions about availability and pricing, patients and families should speak with their physician or contact Axsome Therapeutics directly.
About the Alzheimer's Association
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.