CAPLYTA - Dosing - Timing of Dose

SUMMARY

• The recommended CAPLYTA dosage is 42 mg administered orally once daily with or without food. Dose titration is not required.¹ 
• For patients receiving concomitant moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors, the recommended dosage is CAPLYTA 21 mg once daily or 10.5 mg once daily, respectively.¹
• For patients with moderate or severe hepatic impairment, the recommended dosage is 21 mg once daily.¹
• CAPLYTA was administered in the morning during short-term schizophrenia studies (Studies 005, 301, and 302),^2-5 in the evening during long-term schizophrenia study (Study 303),^6,7 in the evening during studies for bipolar depression (Studies 401, 402, and 404),^8-10 and in the evening during studies for adjunctive major depressive disorder (MDD; Studies 501, 502, and 503).^11-13

PRODUCT LABELING

Recommended Dosage

The recommended CAPLYTA dosage is 42 mg administered orally once daily with or without food. Dose titration is not required.¹

Dosage Recommendations for Concomitant Use with Moderate or Strong CYP3A4 Inhibitors

The recommended CAPLYTA dosage in patients who receive:

• Strong CYP3A4 inhibitors is 10.5 mg once daily.
• Moderate CYP3A4 inhibitors is 21 mg once daily.¹

Dosage Recommendations for Patients with Hepatic Impairment

For patients with moderate hepatic impairment (HI) (Child-Pugh class B) or severe HI (Child-Pugh class C), the recommended CAPLYTA dosage is 21 mg once daily. The recommended CAPLYTA dosage in patients with mild HI is the same as those with normal hepatic function.¹

CLINICAL DATA

CAPLYTA was administered in the morning during short-term schizophrenia studies,^2-5 in the evening during long-term schizophrenia studies,^6,7 in the evening during studies for bipolar depression,^8-10 and in the evening during studies for MDD.^11-13 

Schizophrenia

Kane et al (2021)² performed a pooled analysis of 3 randomized, double-blind, placebo-controlled trials (i.e., Studies 005, 301, and 302) to assess the safety and tolerability of CAPLYTA 42 mg for the treatment of schizophrenia. The pooled population comprised 1073 patients with an acute exacerbation of schizophrenia (CAPLYTA 42 mg [n=406], risperidone 4 mg [n=255], or placebo [n=412]). Patients were treated with CAPLYTA for 4 weeks in studies 005 and 301 and for 6 weeks in Study 302. Additionally, Studies 005 and 302 included risperidone 4 mg as an active control for assay sensitivity. CAPLYTA was dosed in the morning.^3-5

Correll et al (2020)⁶ presented the results of an open-label, long-term study that evaluated the effectiveness and safety of CAPLYTA 42 mg in patients with schizophrenia and stable symptoms for up to 1 year (N=602). CAPLYTA was dosed in the evening.⁷ 

Bipolar Depression

Correll et al (2026)⁸ conducted a phase 3, 6-week, randomized, double-blind, placebo-controlled study (Study 401) that assessed the efficacy and safety of CAPLYTA 42 mg in patients with MDEs associated with bipolar I or bipolar II disorder. Patients were randomized (1:1:1) to receive lumateperone 28 mg (n=180), CAPLYTA 42 mg (n=184), or placebo (n=185; n values are based on safety population) once daily for 6 weeks. CAPLYTA was dosed in the evening.

Suppes et al (2023)⁹ conducted a phase 3, randomized, double-blind, placebo-controlled, multicenter study (Study 402) to evaluate the efficacy and safety of CAPLYTA as adjunctive therapy to lithium or valproate in patients with MDEs associated with bipolar I or bipolar II disorder. Patients were randomized (1:1:1) to receive lumateperone 28 mg (n=176), CAPLYTA 42 mg (n=177), or placebo (n=175) for 6 weeks; this was followed by a 2-week safety follow-up period. CAPLYTA was dosed in the evening.

Calabrese et al (2021)¹⁰ conducted a 6-week, phase 3, randomized, double-blind, placebo-controlled, multinational study (Study 404) to evaluate the efficacy and safety of CAPLYTA 42 mg in patients with MDEs associated with bipolar I or bipolar II disorder. CAPLYTA was dosed in the evening.

MDD

Durgam et al (2025)¹¹ conducted a phase 3, 6-week, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study to assess the efficacy and safety of CAPLYTA 42 mg adjunctive to ADT in patients with MDD who had an inadequate response to ADT (Study 501). Patients were randomized (1:1) to receive CAPLYTA 42 mg (n=242) or placebo (n=243) as adjunctive therapy to ADT for 6 weeks, followed by a 1-week safety follow-up period. CAPLYTA was dosed in the evening.

Durgam et al (2025)¹² conducted a phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of CAPLYTA 42 mg adjunctive to ADT in patients with MDD who had an inadequate response to ADT (Study 502). Patients were randomized (1:1) to receive CAPLYTA 42 mg (n=242) or placebo (n=238) as adjunctive therapy to ADT for 6 weeks, followed by a 1-week safety follow-up period. CAPLYTA was dosed in the evening.

Durgam et al (2026)¹³ conducted a 26-week OLE study (Study 503) that evaluated the long-term safety and tolerability of CAPLYTA 42 mg as adjunctive therapy to ADT in adult patients with MDD. Patients (N=809) were administered CAPLYTA 42 mg once daily in the evening.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 3 August 2026.