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Caplyta is a prescription atypical antipsychotic containing lumateperone. It is approved for schizophrenia in adults, depressive episodes associated with bipolar I or II disorder in adults, and adjunctive treatment with antidepressants for major depressive disorder in adults. Capsules come in 10.5 mg, 21 mg, and 42 mg strengths.
read more about caplyta ...The exact therapeutic mechanism of lumateperone is unknown. Its activity is thought to involve antagonism at central serotonin 5-HT2A receptors and partial agonism at central dopamine D2 receptors. Lumateperone also binds other dopamine, serotonin, and adrenergic receptors and interacts with the serotonin transporter.
Caplyta treats schizophrenia in adults and bipolar depression associated with bipolar I or II disorder in adults, either alone or with lithium or valproate. It is also used with an antidepressant for major depressive disorder in adults. Safety and efficacy have not been established in pediatric patients.
The recommended dose is 42 mg once daily with or without food, and dose titration is not required. Moderate or severe liver impairment uses 21 mg once daily. Strong or moderate CYP3A4 inhibitors require lower doses, while CYP3A4 inducers are avoided due their effect on lumateperone exposure.
Caplyta carries boxed warnings for increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors in younger people treated with antidepressants. Other risks include neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, low white blood cell counts, low blood pressure, falls, seizures, impaired alertness, and swallowing difficulty.
Caplyta treats adult schizophrenia, bipolar depression, and major depressive disorder as adjunctive treatment with antidepressants.
Caplyta is taken once daily with or without food.
No. The recommended 42 mg dose does not require titration under current prescribing information.
No. Safety and efficacy have not been established in pediatric patients.
CAPLYTA (lumateperone) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209500s017lbl.pdf. Date Accessed September 21, 2026.
CAPLYTA (lumateperone) Patient Information. https://www.caplyta.com/. Date Accessed September 21, 2026.
DailyMed - CAPLYTA (lumateperone) capsule. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db730b06-6351-47fd-8183-e61e61bbead5. Date Accessed September 21, 2026.
Lumateperone. MedlinePlus. https://medlineplus.gov/druginfo/meds/a620014.html. Date Accessed September 21, 2026.
Lumateperone. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Lumateperone. Date Accessed September 21, 2026.