Weight & Metabolics - Bipolar Depression | CAPLYTA® (lumateperone) Skip to Content Now approved for adults with major depressive disorder  (adjunctive) For US Healthcare Professionals For US Healthcare Professionals For Patients Adjunctive MDD Bipolar Depression Schizophrenia For Pharmacists Prescribing Information Request a Rep Menu Disease States Major Depressive Disorder Bipolar I & II Depression Schizophrenia Efficacy Adjunctive MDD Primary: MADRS Total Score MADRS Individual Scores MADRS Anxious Distress Bipolar I & II Depression Primary Efficacy Disease Severity Quality of Life Bipolar II Pooled Data Schizophrenia Primary Efficacy PANSS Subscales Prosocial Subscale Safety & Tolerability Adjunctive MDD Most Common Adverse Reactions Weight & Metabolic Effects Sexual Side Effects & EPS Bipolar I & II Depression EPS and Akathisia Weight & Metabolic Effects Most Common Adverse Reactions Schizophrenia EPS and Akathisia Weight & Metabolic Effects Most Common Adverse Reactions Long-term Data Dosing & MOA Dosing MOA Savings & Resources Coverage CAPLYTA withMe Resources Savings Card For US Healthcare Professionals For Patients Adjunctive MDD Bipolar Depression Schizophrenia Weight, metabolic parameters, and prolactin 1,2 For bipolar I and II depression in adults Weight change was similar to placebo in 6‑week trials and not common in a 6‑month, open‑label safety trial 1,2 Mean weight change from baseline 1,2 Monotherapy: 6 weeks Adjunctive (with Lithium or Valproate): 6 weeks Open-label, monotherapy: 6 months Weight change (lbs) CAPLYTA (n=338) Placebo (n=356) CAPLYTA (n=166) Placebo (n=170) CAPLYTA (n=127) Weight change (lbs) +0.1 +0.4 0.0 +0.5 -0.02 Monotherapy: 6 weeks Weight change (lbs) CAPLYTA (n=338) Placebo (n=356) Weight change (lbs) +0.1 +0.4 Adjunctive (with Lithium or Valproate) : 6 weeks Weight change (lbs) CAPLYTA (n=166) Placebo (n=170) Weight change (lbs) 0.0 +0.5 Open-label, monotherapy: 6 months Weight change (lbs) CAPLYTA (n=127) Weight change (lbs) -0.02 99% of participants receiving CAPLYTA did not experience clinically significant weight gain 2 * * Defined as ≥7% increase from baseline to 6 weeks. Antipsychotic drugs have been reported to cause metabolic changes, including weight gain. Measure weight when initiating CAPLYTA and monitor periodically during long-term treatment. Please see additional Important Safety Information , including Boxed WARNINGS, below. View study design & full chart description Study design Monotherapy study: 6-week study that randomized 381 patients to either CAPLYTA 42 mg or placebo. Patients were generally moderately to markedly ill. Median age was 45 years (range 18-72 years). 58% were female, 91% were Caucasian, and 8% were African American. 1 The primary efficacy measure was the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Adjunctive therapy study: 6-week study that randomized 529 patients to lithium or valproate with either CAPLYTA 28 mg (two-thirds of the recommended daily dose), CAPLYTA 42 mg, or placebo. Patients were generally moderately to markedly ill. Median age was 46 years (range 18 to 75 years). 58% were female, 88% were Caucasian, and 11% were African American. The treatment effect in the CAPLYTA 28 mg group (vs placebo) was not statistically significant. 1 Long-term study: An open-label study of 127 patients to determine the safety and tolerability of CAPLYTA 42 mg administered orally once daily for up to approximately 6 months in patients with bipolar depression. 1 Full chart description This chart depicts weight change in clinical trials at 6 weeks in patients taking CAPLYTA as monotherapy or adjunctive therapy (with lithium or valproate) and weight change at 6 months for people taking CAPLYTA as monotherapy. Across the monotherapy arm of the study, placebo (n=356) and CAPLYTA (n=338), patients experienced, respectively, +0.4 pounds weight change vs +0.1 pounds weight change. Across the adjunctive (with lithium or valproate) arm of the study, placebo (n=170) and CAPLYTA (n=166), patients experienced, respectively, +0.5 pounds weight change vs 0.0 pounds weight change. In the open-label, long-term monotherapy study, CAPLYTA (n=127), patients experienced -0.02 pounds weight change. Change in metabolic parameters in 6‑week trials and in a 6‑month, open‑label safety trial 1,2 Mean change from baseline in metabolic parameters 1,2†Monotherapy: 6 weeks Adjunctive (with Lithium or Valproate): 6 weeks Open-label, monotherapy: 6 months Metabolic parameters CAPLYTA (n=372) Placebo (n=374) CAPLYTA (n=177) Placebo (n=175) CAPLYTA Glucose (mg/dL) +0.1 0.0 +1.2 +0.8 +2.1 (n=112) Insulin (mIU/L) -0.8 +0.6 +3.5 +0.4 +0.7 (n=111) Hemoglobin A1c (%) 0.0 (n=96) Total cholesterol (mg/dL) -0.6 -1.1 -6.5 -0.7 -2.4 (n=117) LDL cholesterol (mg/dL) -0.7 -0.6 -5.9 -0.6 -5.1 (n=117) HDL cholesterol (mg/dL) +0.4 0.0 -0.6 -0.2 +0.9 (n=117) Triglycerides (mg/dL) -1.4 -4.0 -1.6 -1.2 +2.3 (n=112) Monotherapy: 6 weeks Metabolic parameters CAPLYTA (n=372) Placebo (n=374) Glucose (mg/dL) +0.1 0.0 Insulin (mIU/L) -0.8 +0.6 Hemoglobin A1c (%) Total cholesterol (mg/dL) -0.6 -1.1 LDL cholesterol (mg/dL) -0.7 -0.6 HDL cholesterol (mg/dL) +0.4 0.0 Triglycerides (mg/dL) -1.4 -4.0 Adjunctive (with Lithium or Valproate) : 6 weeks Metabolic parameters CAPLYTA (n=177) Placebo (n=175) Glucose (mg/dL) +1.2 +0.8 Insulin (mIU/L) +3.5 +0.4 Hemoglobin A1c (%) Total cholesterol (mg/dL) -6.5 -0.7 LDL cholesterol (mg/dL) -5.9 -0.6 HDL cholesterol (mg/dL) -0.6 -0.2 Triglycerides (mg/dL) -1.6 -1.2 Open-label, monotherapy: 6 months Metabolic parameters CAPLYTA Glucose (mg/dL) +2.1 (n=112) Insulin (mIU/L) +0.7 (n=111) Hemoglobin A1c (%) 0.0 (n=96) Total cholesterol (mg/dL) -2.4 (n=117) LDL cholesterol (mg/dL) -5.1 (n=117) HDL cholesterol (mg/dL) +0.9 (n=117) Triglycerides (mg/dL) +2.3 (n=112) In 6‑week trials , metabolic parameters were similar to placebo 1 LDL=low-density lipoprotein; HDL=high-density lipoprotein. †n=number of subjects with data. Baseline is defined as last non-missing pretreatment measurement. Antipsychotic drugs have been reported to cause metabolic changes, including hyperglycemia, diabetes mellitus, and dyslipidemia. Assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Please see additional Important Safety Information , including Boxed WARNINGS, below. View full chart description Full chart description This chart depicts mean baseline change in levels of specific metabolic parameters of CAPLYTA vs. Placebo at 6 weeks, as well as CAPLYTA alone at 6 months. Across the monotherapy arm of the study, placebo (n=374) and CAPLYTA (n=372) patients respectively experienced the following: glucose (mg/dL), 0.0 vs 0.1; insulin (mIU/L), 0.6 vs -0.8; total cholesterol (mg/dL), -1.1 vs -0.6; LDL cholesterol (mg/dL), -0.6 vs -0.7; triglycerides (mg/dL), -4.0 vs -1.4. Across the adjunctive therapy (with lithium or valproate) arm of the study, placebo (n=175) and CAPLYTA (n=177) patients respectively experienced the following: glucose (mg/dL), 0.8 vs 1.2; insulin (mIU/L), 0.4 vs 3.5; total cholesterol (mg/dL), -0.7 vs -6.5; LDL cholesterol (mg/dL), -0.6 vs -5.9; triglycerides (mg/dL), -1.2 vs -1.6. At 6 months, CAPLYTA demonstrated the following changes: glucose (mg/dL), 2.1 (n=112); insulin (mIU/L), 0.7 (n=111); hemoglobin A1c (%), 0.0 (n=96); total cholesterol (mg/dL), -2.4 (n=117); LDL cholesterol (mg/dL), -5.1 (n=117); HDL cholesterol (mg/dL), 0.9 (n=117); triglycerides (mg/dL), 2.3 (n=112). Prolactin levels in 6‑week trials and in a 6‑month, open‑label safety trial 1,2 Prolactin levels in clinical trials 1,2 Monotherapy: 6 weeks Adjunctive (with Lithium or Valproate): 6 weeks Open-label, monotherapy: 6 months Prolactin CAPLYTA (n=372) Placebo (n=374) CAPLYTA (n=164) Placebo (n=170) CAPLYTA (n=115) Mean change from baseline (µg/L) -0.2 +1.1 +0.63 +1.78 +1.09 Monotherapy: 6 weeks Prolactin CAPLYTA (n=372) Placebo (n=374) Mean change from baseline (µg/L) -0.2 +1.1 Adjunctive (with Lithium or Valproate) : 6 weeks Prolactin CAPLYTA (n=164) Placebo (n=170) Mean change from baseline (µg/L) +0.63 +1.78 Open-label, monotherapy: 6 months Prolactin CAPLYTA (n=115) Mean change from baseline (µg/L) +1.09 Prolactin-related TEAE levels in clinical trials 1,2 Monotherapy: 6 weeks Adjunctive (with Lithium or Valproate): 6 weeks Prolactin-related TEAEs CAPLYTA (n=372) Placebo (n=374) CAPLYTA (n=177) Placebo (n=175) Blood prolactin increased 1.3% 0.3% 2.3% 0.0% Hyperprolactinemia 0.3% 0.8% 0.6% 3.4% Monotherapy: 6 weeks Prolactin-related TEAEs CAPLYTA (n=372) Placebo (n=374) Blood prolactin increased 1.3% 0.3% Hyperprolactinemia 0.3% 0.8% Adjunctive (with Lithium or Valproate): 6 weeks Prolactin-related TEAEs CAPLYTA (n=177) Placebo (n=175) Blood prolactin increased 2.3% 0.0% Hyperprolactinemia 0.6% 3.4% Clinically significant elevation of prolactin levels in clinical trials 1,2 Monotherapy: 6 weeks Adjunctive (with Lithium or Valproate): 6 weeks Clinically significant elevations CAPLYTA (n=335) Placebo (n=355) CAPLYTA (n=162) Placebo (n=170) Prolactin (≥5x upper limit of normal) 0.3% 0.6% 1.2% 1.2% Monotherapy: 6 weeks Clinically significant elevations CAPLYTA (n=335) Placebo (n=355) Prolactin (≥5x upper limit of normal) 0.3% 0.6% Adjunctive (with Lithium or Valproate): 6 weeks Clinically significant elevations CAPLYTA (n=162) Placebo (n=170) Prolactin (≥5x upper limit of normal) 1.2% 1.2% TEAEs=treatment-emergent adverse events. In 6‑week trials , prolactin levels were similar to placebo 1 WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause: Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Please see additional Important Safety Information , including Boxed WARNINGS, below. View full chart description Full chart description This chart depicts prolactin levels with CAPLYTA vs placebo at 6 weeks and prolactin levels with CAPLYTA at 6 months. At 6 weeks, across the monotherapy arm of the study, placebo (n=374) and CAPLYTA (n=372), patients experienced prolactin mean change from baseline (µg/L), respectively: 1.1 vs -0.2; patients experienced the following prolactin-related TEAEs, respectively: blood prolactin increased, 0.3% vs 1.3%; hyperprolactinemia, 0.8% vs 0.3%; placebo (n=355) and CAPLYTA (n=335), patients experienced clinically significant elevations, prolactin (≥5x upper limit of normal), respectively, 0.6% vs 0.3%. Across the adjunctive (with lithium or valproate) arm of the study, placebo (n=170) and CAPLYTA (n=164), patients experienced prolactin mean change from baseline (µg/L), respectively: 1.78 vs 0.63; placebo (n=175) and CAPLYTA (n=177), patients experienced the following prolactin-related TEAEs, respectively: blood prolactin increased, 0.0% vs 2.3%; hyperprolactinemia, 3.4% vs 0.6%; placebo (n=170) and CAPLYTA (n=162), patients experienced clinically significant elevations, prolactin (≥5x upper limit of normal), respectively, 1.2% vs 1.2%. At 6 months, patients taking CAPLYTA experienced prolactin mean change from baseline (µg/L) of 1.09 (n=115). CAPLYTA demonstrated safety in 2,664 adult patients with schizophrenia and bipolar depression 1 Most Common Adverse Reactions Indications CAPLYTA is indicated in adults for adjunctive therapy along with antidepressants for the treatment of major depressive disorder (MDD); the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate; and the treatment of schizophrenia. Important Safety Information BOXED WARNINGS: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with a history of hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis , including stroke and transient ischemic attack. See Boxed WARNING above. Neuroleptic Malignant Syndrome , which is a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring. Tardive Dyskinesia (TD) may develop in patients treated with antipsychotic drugs, including CAPLYTA. TD can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. The TD risk appears to be highest in elderly women. The likelihood that TD will become irreversible increases with the duration of the antipsychotic drug treatment and cumulative dose. If signs and symptoms of TD appear, consider discontinuing CAPLYTA if clinically appropriate. Metabolic Changes , including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases) . Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. 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 absolute neutrophil count <1000/mm 3 and monitor closely until neutropenia resolves. Orthostatic Hypotension and Syncope . Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls . CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for fall risk when initiating treatment and periodically during long-term treatment. Seizures . Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment . Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation . Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia . Use CAPLYTA with caution in patients at risk for aspiration. Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4 inhibitors (21 mg). Increased monitoring for serotonin reuptake inhibitor (SRI)‑associated adverse reactions is recommended when used with SRIs; including in geriatric patients who may be at greater risk for clinically significant hyponatremia. Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Reduce dose for patients with moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment (21 mg). Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than twice placebo) with CAPLYTA vs placebo were: Major Depressive Disorder (Adjunctive therapy): dizziness (17% vs 5%), dry mouth (13% vs 3%), somnolence/sedation (12% vs 2%), nausea (9% vs 4%), fatigue (8% vs 2%), and diarrhea (5% vs 1%). Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%). Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%). CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. Indications CAPLYTA is indicated in adults for adjunctive therapy along with antidepressants for the treatment of major depressive disorder (MDD); the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate; and the treatment of schizophrenia. US‑CAP‑2500828 Please see full Prescribing Information , including Boxed WARNINGS. Savings Card Local Coverage  Finder Samples Indications CAPLYTA is indicated in adults for adjunctive therapy along with antidepressants for the treatment of major depressive disorder (MDD); the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate; and the treatment of schizophrenia. Important Safety Information BOXED WARNINGS: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with a history of hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis , including stroke and transient ischemic attack. See Boxed WARNING above. Neuroleptic Malignant Syndrome , which is a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring. Tardive Dyskinesia (TD) may develop in patients treated with antipsychotic drugs, including CAPLYTA. TD can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. The TD risk appears to be highest in elderly women. The likelihood that TD will become irreversible increases with the duration of the antipsychotic drug treatment and cumulative dose. If signs and symptoms of TD appear, consider discontinuing CAPLYTA if clinically appropriate. Metabolic Changes , including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases) . Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. 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 absolute neutrophil count <1000/mm 3 and monitor closely until neutropenia resolves. Orthostatic Hypotension and Syncope . Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls . CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for fall risk when initiating treatment and periodically during long-term treatment. Seizures . Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment . Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation . Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia . Use CAPLYTA with caution in patients at risk for aspiration. Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4 inhibitors (21 mg). Increased monitoring for serotonin reuptake inhibitor (SRI)‑associated adverse reactions is recommended when used with SRIs; including in geriatric patients who may be at greater risk for clinically significant hyponatremia. Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Reduce dose for patients with moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment (21 mg). Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than twice placebo) with CAPLYTA vs placebo were: Major Depressive Disorder (Adjunctive therapy): dizziness (17% vs 5%), dry mouth (13% vs 3%), somnolence/sedation (12% vs 2%), nausea (9% vs 4%), fatigue (8% vs 2%), and diarrhea (5% vs 1%). Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%). Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%). CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. Indications CAPLYTA is indicated in adults for adjunctive therapy along with antidepressants for the treatment of major depressive disorder (MDD); the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate; and the treatment of schizophrenia. US‑CAP‑2500828 Please see full Prescribing Information , including Boxed WARNINGS. References: 1. CAPLYTA prescribing information. 2. Data on File (REF-01380, REF-01533). Terms of Use Privacy Policy Cookie Policy Contact Us Disclosures ITCI Corporate Site Sitemap Your Privacy Choices AdChoices Opt-out © Johnson & Johnson and its affiliates 2025. CAPLYTA and LET IN THE LYTE are trademarks of Johnson & Johnson and its affiliates. Trademarks listed are the property of their respective owners. 10/25 US-CAP-2500203 Important Safety Information See Full ISI BOXED WARNINGS: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.