As of April 2025, the U.S. Food and Drug Administration (FDA) has approved brexpiprazole (Rexulti) for the treatment of agitation associated with dementia due to Alzheimer’s disease. This approval, granted in May 2023, marks the first FDA-sanctioned medication for this specific indication.
Prior to this, while antipsychotic medications were frequently employed off-label to manage behavioral and psychological symptoms of dementia (BPSD), none had received FDA approval for such use. It’s important to note that the FDA has issued warnings regarding the use of antipsychotics in elderly patients with dementia, citing an increased risk of death.
In summary, brexpiprazole (Rexulti) is currently the only antipsychotic approved by the FDA for treating agitation associated with dementia due to Alzheimer’s disease.
