Drug Approved to Treat Dementia Agitation

New options offer hope for Alzheimer’s patients and their families.

For those grappling with dementia-related agitation, a condition affecting approximately half of all Alzheimer’s patients, new treatments and management strategies are emerging, offering a beacon of hope for improved care and quality of life. This condition often leads to significant cognitive and functional decline.

Treatment Challenges

Psychiatric clinicians have long encountered considerable difficulties in supporting patients experiencing agitation linked to dementia, especially with limited FDA-approved treatments. **Gerald Maguire**, MD, highlighted these challenges at the 2025 Southern California Psychiatry Conference, noting the restrictions and warnings accompanying commonly used treatments.

“For years… we had nothing FDA approved to treat them,” stated **Maguire**, director of residency training in psychiatry at College Medical Center in Long Beach, California. He added that previously used agents even carried box warnings “about the risk potentially of increased mortality, cerebrovascular adverse events with antipsychotic agents in patients with agitation associated with dementia.”

According to **Maguire**, SSRIs and benzodiazepines often prove ineffective in these cases.

A Shift in Treatment Landscape

The treatment landscape is evolving, with new options becoming available. “Fortunately, we have one agent that is on label now… for the treatment of patients with agitation associated with dementia due to Alzheimer’s,” **Maguire** shared.

Brexpiprazole (Rexulti; 2mg to 3mg per day) gained FDA approval in 2023 for treating agitation associated with dementia stemming from Alzheimer’s disease. The drug impacts noradrenergic, serotonin, and dopamine monoamine systems. **Maguire** also mentioned AXS-05 (bupropion/dextromethorphan) as another potential treatment on the horizon, showcasing positive results in trials such as ADVANCE and ACCORD.

Non-Pharmacological Interventions

Despite these new drug options, **Maguire** stressed the importance of considering non-pharmacological and medical factors before starting any treatment. He urged clinicians to consider possible causes of agitation, such as environmental changes. It’s worth noting that since 2000, dementia-related deaths have more than doubled, underscoring the urgency for effective interventions (CDC).

“Could there be something that’s leading to the agitation? Has a patient… had a change in environment?” he questioned. Environmental disruptions, untreated pain, and comorbid medical conditions, for instance infections or metabolic disturbances, should be ruled out. “Before we go adding on another medicine, make sure that we know medically what’s also going on for that patient.”

The Importance of Timely Intervention

**Maguire** emphasized the critical need for timely intervention, noting that “agitation in and of itself leads to a poor prognostic outcome for patients with dementia.” Effective management of agitation can improve quality of life and potentially delay transitions to more restrictive care environments, allowing patients to remain at home with their families longer.