As of now, no antipsychotic is FDA-approved specifically for the treatment of dementia with BPSD (Behavioral and Psychological Symptoms of Dementia) such as agitation, aggression, or psychosis.
Here’s the regulatory situation:
✅ What
is
FDA-approved in dementia/BPSD?
- Brexpiprazole (Rexulti)
- FDA approval (May 2023): Brexpiprazole became the first and only drug approved by the FDA for the treatment of agitation associated with Alzheimer’s dementia.
- Important nuance: This approval is for agitation, not for the full range of BPSD (e.g., hallucinations, delusions, wandering).
- Label includes a Boxed Warning (like other antipsychotics) about increased risk of mortality in elderly patients with dementia-related psychosis.
❌ Antipsychotics NOT approved for BPSD (but widely used
off-label
)
- Risperidone, Olanzapine, Quetiapine, Aripiprazole, Haloperidol
- Sometimes used off-label to manage agitation, aggression, or psychosis in dementia, but none have FDA approval for this indication.
- They all carry the Boxed Warning about increased risk of death in elderly patients with dementia-related psychosis.
📝 Summary
- FDA-approved: Only Brexpiprazole (Rexulti), for agitation in Alzheimer’s dementia (approved 2023).
- Not FDA-approved: All other antipsychotics (risperidone, olanzapine, quetiapine, haloperidol, aripiprazole, etc.) — used off-label, with significant caution due to safety risks.
👉 Would you like me to also give you a comparative table showing evidence strength and safety concerns for the main antipsychotics used off-label in dementia, so you can see where Rexulti stands among them?
