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Medication Guide

Now approved for Major Depressive Disorderas an add-on to an antidepressant

When you need more
from your antidepressant,

ADDING CAPLYTA
MAY HELP

Keep building on the progress you've made. Adding once‑daily CAPLYTA to your antidepressant is proven to significantly relieve depression symptoms more than an antidepressant alone.

See CAPLYTA Results

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CAPLYTA can help Let in the LYTE

Transcript

CAPLYTA TV Commercial

(SONG)

This little LYTE of mine

(DESCRIPTION)

A woman sits by a window in the morning.

(ON SCREEN TEXT)

Actor portrayals

(SONG)

Has been dark for quite some time

(DESCRIPTION)

The woman lies in bed in her bedroom.

(SONG)

Then I let in the LYTE to help see / More of the LYTE inside of me

(DESCRIPTION)

The woman steps outside on a sunny patio to write in her journal.

(ON SCREEN TEXT)

[CAPLYTA^® logo]

[LET IN THE LYTE logo]

(VOICEOVER)

I needed more from my antidepressant, so my doctor added CAPLYTA—proven to provide greater relief from depression symptoms than an antidepressant alone, building on my progress without starting over.

(ON SCREEN TEXT)

ADD [CAPLYTA^® logo]

For adults with major depressive disorder (MDD) used with an antidepressant. Available by prescription only. Not approved for people under 18.

(ON SCREEN TEXT)

CAPLYTA + ANTIDEPRESSANT

GREATER RELIEF FROM DEPRESSION SYMPTOMS THAN AN ANTIDEPRESSANT ALONE

Proven in 6-week studies in adults with MDD who still had depression symptoms while taking an antidepressant. Individual results vary.

(VOICEOVER)

Weight gain and reported sexual side effects were not common.

(ON SCREEN TEXT)

IN CLINICAL TRIALS, WEIGHT GAIN & REPORTED SEXUAL SIDE EFFECTS* WERE NOT COMMON

High cholesterol and weight gain may occur, as can high blood sugar, which may be fatal. Monitoring is recommended.

*In trials, weight gain and patient-reported sexual side effects were similar with CAPLYTA plus an antidepressant and an antidepressant alone.

(DESCRIPTION)

The woman joins an outdoor workout class in a park. She exercises with others.

(ON SCREEN TEXT)

Elderly dementia patients have increased risk of death or stroke. CAPLYTA is not approved for dementia-related psychosis.

(VOICEOVER)

Elderly dementia patients have increased risk of death or stroke. CAPLYTA is not approved for dementia-related psychosis.

(DESCRIPTION)

The woman is at the beach with her family. A dog runs to her with a ball, she pets the dog, and they sit together under an umbrella.

(ON SCREEN TEXT)

Call your doctor about new or sudden mood changes, behaviors, or suicidal thoughts right away. Antidepressants may increase these risks. Report fever, confusion, stiff muscles, which may be life-threatening, or uncontrolled muscle movements, which may be permanent.

(VOICEOVER)

Call your doctor about new or sudden mood changes, behaviors, or suicidal thoughts right away. Antidepressants may increase these risks. Report fever, confusion, stiff muscles, which may be life-threatening, or uncontrolled muscle movements, which may be permanent.

(DESCRIPTION)

The woman reads a book while her husband and child build a sandcastle. They gather for a picture as the dog joins them.

(ON SCREEN TEXT)

High cholesterol and weight gain may occur, as can high blood sugar, which may be fatal. Monitoring is recommended. Common side effects are sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These aren't all the side effects.

(VOICEOVER)

High cholesterol and weight gain may occur, as can high blood sugar, which may be fatal. Common side effects are sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These aren't all the side effects.

(DESCRIPTION)

The woman looks at a picture on her phone while her family continues building the sandcastle.

(ON SCREEN TEXT)

To learn more, visit CAPLYTA.COM or call 888-252-4824

(VOICEOVER)

Ask your doctor about CAPLYTA.

(DESCRIPTION)

The words LET IN THE LYTE appear on screen.

(ON SCREEN TEXT)

LET IN THE LYTE

(SONG)

Help see more of the LYTE inside of me

(ON SCREEN TEXT)

[CAPLYTA^® / Johnson & Johnson logo]

Eligible patients may pay as little as $0 for 30-day or 90-day prescriptions and for a generic antidepressant.

Maximum savings limit applies; patient out-of-pocket expense may vary. Please see Program Eligibility Criteria and Terms & Conditions.

© Johnson & Johnson and its affiliates 2025. 10/25 US-CAP-2500084

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.