Ask Your Doctor About CAPLYTA® (lumateperone) Skip to Main Content For US Residents Only Visit US Healthcare Professionals Site Important Safety Information Prescribing Information Medication Guide Other Indications Important Safety Information Medication Guide Your browser does not support the audio element. Cost & Savings Close Menu About Major Depressive Disorder About CAPLYTA CAPLYTA Results Taking CAPLYTA Common Side Effects Tools & Resources Helpful Tools Additional Resources Ask About CAPLYTA Cost & Savings For US Residents only Prescribing Information Other Indications Bipolar Depression Other Indication Visit US Healthcare Professionals Site Your browser does not support the audio element. About Major Depressive Disorder About CAPLYTA CAPLYTA Results Taking CAPLYTA Common Side Effects Tools & Resources Helpful Tools Additional Resources Ask About CAPLYTA Cost & Savings Ask About CAPLYTA Get ready for your next visit Actor portrayal. Preparing for your visit Use these questions with your healthcare provider to help start the conversation about CAPLYTA. Could adding CAPLYTA help improve my depression symptoms? How quickly will CAPLYTA start working? What are the common side effects of CAPLYTA? Will CAPLYTA make me gain weight? Can I take other medications with CAPLYTA? Is there a good time of day to take CAPLYTA? Will CAPLYTA make me sleepy? Doctor Discussion Guide Use this interactive tool to build a personalized discussion guide you can bring to your next appointment. Build Your Doctor Discussion Guide It's OK if you forget to ask It's OK if you forget to ask something during the appointment One tip is to keep a little notepad with you or at home to use whenever you think of anything that you want to ask. Then, you can bring it up at your next appointment or call your healthcare provider about it. Important Safety Information and Indications Expand IMPORTANT SAFETY INFORMATION Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately. Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat). CAPLYTA may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS. Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA. Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity. Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA. Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position. Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries. Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities. Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA. Difficulty swallowing that can cause food or liquid to get into the lungs. The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. INDICATIONS CAPLYTA is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children. Please see Medication Guide , including Boxed WARNINGS. IMPORTANT SAFETY INFORMATION Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately. Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat). CAPLYTA may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS. Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA. Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity. Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA. Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position. Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries. Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities. Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA. Difficulty swallowing that can cause food or liquid to get into the lungs. The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. INDICATIONS CAPLYTA is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children. Please see Medication Guide , including Boxed WARNINGS. Terms of Use Privacy Policy Cookie Policy Contact Us References 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. 11/25 US-CAP-2500128