Caplyta (lumateperone) is an atypical antipsychotic indicated for the treatment of adults with schizophrenia, bipolar depression, and major depressive disorder. It was first approved in December of 2019 for schizophrenia and has since received additional approvals for treating adults with bipolar depression and major depressive disorder.
Read on to learn more about Caplyta, including its dosage and administration information, warnings and precautions, and more.
Medication Overview:
- Brand Name: Caplyta
- Generic Name: Lumateperone
- Treatment for: Schizophrenia, bipolar depression, major depressive disorder
- Manufacturer(s): Intra-Cellular Therapies
- Initial FDA Approval: December 2019
| Indicated Condition | Indication | Age | Initial Approval |
|---|---|---|---|
| Schizophrenia | Caplyta is an atypical antipsychotic indicated for treatment of schizophrenia in adults. | Adults | December 2019 |
| Bipolar Depression | Caplyta is an atypical antipsychotic indicated for treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. | Adults | December 2021 |
| Major Depressive Disorder | Caplyta is an atypical antipsychotic indicated for adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. | Adults | November 2025 |
Warnings and Precautions:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke and transient ischemic attack).
- Neuroleptic Malignant Syndrome: If NMS is suspected, immediately discontinue Caplyta and provide intensive symptomatic treatment and monitoring.
- Tardive Dyskinesia: If signs and symptoms of TD occur consider discontinuing Caplyta treatment.
- Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
- Leukopenia, Neutropenia, and Agranulocytosis: In patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia, perform complete blood counts (CBC). Consider discontinuing Caplyta if clinically significant decline in WBC occurs in absence of other causative factors. Discontinue Caplyta in patients with clinically significant neutropenia or ANC < 1000/mm3 and monitor closely until the neutropenia resolve.
- Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure in patients who are vulnerable to hypotension.
- Seizures: Use cautiously in patients with a history of seizures or with other conditions that lower seizure threshold.
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery and driving a motor vehicle until patients are reasonably certain that therapy with Caplyta does not affect them adversely.
Dosage and Administration:
- Recommended oral dosage of Caplyta is 42 mg once daily with or without food.
- Moderate hepatic impairment or severe hepatic impairment: Recommended dosage is 21 mg once daily.
Contraindications:
Caplyta is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of Caplyta.
Drug Interactions:
- CYP3A4 inducers: Avoid concomitant use with Caplyta.
- Strong CYP3A4 inhibitors: Recommended dosage is 10.5 mg once daily.
- Moderate CYP3A4 inhibitors: Recommended dosage is 21 mg once daily.
Adverse Reactions:
Most common adverse reactions in clinical trials (incidence ≥5% and greater than twice placebo) were:
- Schizophrenia: somnolence/sedation and dry mouth.
- Bipolar depression: somnolence/sedation, dizziness, nausea, dry mouth.
- MDD: dizziness, dry mouth, somnolence/sedation, nausea, fatigue, diarrhea.
Examples of Lumateperone in Guidelines
Management of Bipolar Disorder
- Veterans Health Administration / Department of Defense (VA/DoD), October 2023
- “If quetiapine is not selected based on patient preference and characteristics, we suggest cariprazine, lumateperone, lurasidone, or olanzapine as monotherapy for acute bipolar depression.”
Management of Post-Traumatic Stress Disorder and Acute Stress Disorder
- Veterans Health Administration / Department of Defense (VA/DoD), July 2023
- “We suggest against aripiprazole, asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone for augmentation of medications for the treatment of PTSD.”
Beers Criteria for Potentially Inappropriate Medication Use in Older Adults
- American Geriatrics Society (AGS), March 2023
- “Lumateperone: Avoid except in some situations (e.g. bipolar disorder, schizophrenia, short-term chemotherapy).”
Please note: This article is current as of March 9, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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