FDA Approves Rexulti (brexpiprazole) for Agitation in Alzheimer's Dementia

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FDA Published May 5, 2026 Medically reviewed May 5, 2026 DOI ↗ By Dr. Ji-eun Park, MD · Brain, Mind & Pain

Key Takeaway

Note: Rexulti is approved for agitation in Alzheimer's dementia but not for prn use; follow specific titration schedule.

The FDA has approved Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer's disease, expanding the atypical antipsychotic's indications. This approval provides a new option for managing a challenging symptom in this population. The recommended starting dose is 0.5 mg once daily for the first week, titrated to 1 mg on days 8-14, then to 2 mg on day 15. The maximum dose is 3 mg daily. Clinicians should note that Rexulti is not approved for as-needed (prn) use. The approval is based on clinical studies demonstrating efficacy, though specific trial data are not detailed in the label. Safety considerations include boxed warnings for increased mortality in elderly patients with dementia-related psychosis, as with other antipsychotics.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Rexulti is indicated for treatment of agitation associated with dementia due to Alzheimer's disease in adults. Limitation of Use: Not indicated as an as-needed (prn) treatment.

Dosing & Administration

Administer orally once daily with or without food. Starting dosage: 0.5 mg once daily on Days 1 to 7. Increase to 1 mg once daily on Days 8 through 14, then to 2 mg once daily on Day 15. Recommended target dose: 2 mg once daily. Maximum dose: 3 mg once daily (increase after at least 14 days based on response/tolerability). For moderate to severe hepatic impairment (Child-Pugh ≥7) or CrCl <60 mL/min: maximum 2 mg once daily. See label for CYP2D6 poor metabolizer and drug interaction adjustments.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Rexulti offers a new treatment option for agitation in Alzheimer's dementia, with a specific dosing regimen. It is not for prn use. As an atypical antipsychotic, it carries risks including increased mortality in elderly dementia patients, though specific warnings are not detailed in this label excerpt.

Study Details

Study typeFda approval

PublishedJul 2015

View Original Abstract ↓

1 INDICATIONS AND USAGE REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ] . REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years and older ( 1 , 14.2 ) Treatment of agitation associated with dementia due to Alzheimer's disease ( 1 , 14.3 ) Limitations of Use : REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease ( 1 )