Weight & Metabolics - Schizophrenia | 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 change, metabolic parameters, and prolactin 1,2 For schizophrenia in adults Mean change in body weight from baseline was similar to placebo 1,2 In 4- to 6‑week clinical trials, at 4 weeks (+3.5 lbs for CAPLYTA 42 mg and +2.9 lbs for placebo) 1,2 In a 1‑year, open label safety trial with CAPLYTA, patients saw an average weight change of 1 : Metabolic parameters in 4- to 6‑week trials and in a 1‑year, open‑label safety trial 1,2 Mean change from baseline in metabolic parameters 1,2 4- to 6-week trials Open-label trial: day 300 Proportion of patients (%) CAPLYTA (n=406) Placebo (n=412) CAPLYTA Glucose (mg/dL) +0.7 +2.1 +3.0 (n=172) Insulin (µIU/mL) +1.0 (n=168) Total cholesterol (mg/dL) -3.0 -1.6 -9.6 (n=172) LDL cholesterol (mg/dL) -7.6 (n=167) HDL cholesterol (mg/dL) -1.4 (n=172) Triglycerides (mg/dL) -1.7 +4.6 -2.5 (n=172) 4- to 6-week trials Proportion of patients (%) CAPLYTA (n=406) Placebo (n=412) Glucose (mg/dL) +0.7 +2.1 Insulin (µIU/mL) Total cholesterol (mg/dL) -3.0 -1.6 LDL cholesterol (mg/dL) HDL cholesterol (mg/dL) Triglycerides (mg/dL) -1.7 +4.6 Open-label trial: day 300 Proportion of patients (%) CAPLYTA Glucose (mg/dL) +3.0 (n=172) Insulin (µIU/mL) +1.0 (n=168) Total cholesterol (mg/dL) -9.6 (n=172) LDL cholesterol (mg/dL) -7.6 (n=167) HDL cholesterol (mg/dL) -1.4 (n=172) Triglycerides (mg/dL) -2.5 (n=172) In 4- to 6‑week trials , metabolic parameters were similar to placebo 1 CAPLYTA mean change from baseline was similar to placebo in terms of glucose, total cholesterol, and triglycerides 1 LDL=low-density lipoprotein; HDL=high-density lipoprotein. * n=number of subjects with data. Baseline is defined as last non-missing pretreatment measurement. 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 study design & full chart description Study design Short-term (4- to 6-week) data is from a placebo-controlled study of 811 patients with schizophrenia taking doses of CAPLYTA ranging from 14 to 84 mg/day. 2 Long-term data is from an open-label study of 603 stable outpatients with schizophrenia who discontinued their current antipsychotic treatment and started CAPLYTA 42 mg with no dose titration. Assessment of safety, tolerability, and efficacy were conducted at baseline and were measured at Day 8, 15, 25, and approximately every 25 days thereafter, for up to 1 year. 2 The primary objective was to evaluate the safety and tolerability of CAPLYTA. 2 Full chart description This graph depicts the mean change from baseline glucose levels, total cholesterol levels, and triglycerides levels over 4- to 6-weeks for patients receiving CAPLYTA 42 mg or placebo and at day 300 for patients receiving CAPLYTA 42 mg. Over 4- to 6-weeks, patients on CAPLYTA saw a 0.7-point increase in glucose vs 2.1-point increase for those on placebo. Patients on CAPLYTA saw a 3.0-point reduction in total cholesterol vs 1.6-point reduction for those on placebo. Patients on CAPLYTA saw a 1.7-point reduction in triglycerides vs 4.6-point increase for those on placebo. At day 300, patients on CAPLYTA saw a 3.0-point increase in glucose (n=172), a 1.0-point increase in insulin (n=168), a 9.6-point reduction in total cholesterol (n=172), a 7.6-point reduction in LDL cholesterol (n=167), a 1.4-point reduction in HDL cholesterol (n=172), and a 2.5-point reduction in triglycerides (n=172). Changes in prolactin in 4- to 6‑week trials and in a 1‑year, open‑label safety trial 2 Mean change from baseline in prolactin 2 4- to 6-week trials Open-label, monotherapy: day 300 Proportion of patients (%) CAPLYTA (n=406) Placebo (n=412) CAPLYTA (n=171) Prolactin (ng/mL) -1.3 -0.2 -4.9 4- to 6-week trials Proportion of patients (%) CAPLYTA (n=406) Placebo (n=412) Prolactin (ng/mL) -1.3 -0.2 Open-label, monotherapy: day 300 Open-label, monotherapy: day 300 CAPLYTA (n=171) Prolactin (ng/mL) -4.9 In 4- 6‑week trials , prolactin levels were similar to placebo 1 View full chart description Full chart description This graph depicts the mean change in prolactin from baseline at 4 weeks for patients receiving CAPLYTA 42 mg or placebo and at day 300 for patients receiving CAPLYTA 42 mg. At 4- to 6-weeks, patients on CAPLYTA saw a 1.3-point reduction in prolactin vs 0.2-point reduction for those on placebo. At day 300, patients on CAPLYTA saw a 4.9-point reduction in prolactin. ≥80% of patients on CAPLYTA remained normal in key metabolic parameters at Day 300 2†Proportion of patients (%) whose key metabolic parameters shifted between normal, low, and high 2 Baseline Normal Proportion of patients (%) Shifted Normal to Low Remained Normal Shifted Normal to High Glucose (n=172) < 1% (1/151) 91% (138/151) 8% (12/151) Insulin (n=168) 5% (7/134) 83% (111/134) 12% (16/134) Total cholesterol (n=172) 12% (14/120) 80% (96/120) 8% (10/120) LDL cholesterol (n=167) 3% (4/149) 93% (139/149) 4% (6/149) Triglycerides (n=172) 4% (6/155) 92% (142/155) 4.5% (7/155) Baseline Normal Proportion of patients (%) Shifted Normal to Low Remained Normal Shifted Normal to High Glucose (n=172) < 1% (1/151) 91% (138/151) 8% (12/151) Insulin (n=168) 5% (7/134) 83% (111/134) 12% (16/134) Total cholesterol (n=172) 12% (14/120) 80% (96/120) 8% (10/120) LDL cholesterol (n=167) 3% (4/149) 93% (139/149) 4% (6/149) Triglycerides (n=172) 4% (6/155) 92% (142/155) 4.5% (7/155) †n=number of subjects with data. Baseline is defined as the last non-missing pretreatment measurement. 2 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. 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-00793, REF-00813). 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.