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Caplyta

Pronunciation: kap-LITE-ah
Generic name: lumateperone
Dosage form: oral capsule
Drug class: Atypical antipsychotics

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 20, 2024.

What is Caplyta?

Caplyta (lumateperone) is used to treat adults with schizophrenia or depression associated with bipolar 1 or 2 disorder (manic depression).

Caplyta's mechanism of action involves changing the activity of neurotransmitters in the brain, such as dopamine, glutamate, and serotonin to increase or balance their levels. Caplyta helps relieve symptoms such as hallucinations, delusions, and disorganized thoughts associated with schizophrenia, and low mood associated with bipolar depression. See What is the mechanism of action for Caplyta? for more information.

Caplyta gained FDA approval on December 20, 2019. Caplyta belongs to the drug class called atypical antipsychotics. 

Caplyta price

Caplyta's cost is covered for approximately 90% of people with commercial insurance. With a Caplyta Savings Card, eligible patients may pay as little as $0 for their first 2 fills and $15 for subsequent fills.

For those with Medicaid and Medicare Part D, Caplyta is covered for more than 99% of people.

See Caplyta Prices, Coupons, Copay Cards & Patient Assistance for more information about the cost of Caplyta.

Caplyta side effects

The most common side effects of Caplyta are:

Caplyta does not appear to be associated with weight gain. See Does Caplyta cause weight gain? for more information.

Caplyta may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Serious side effects and warnings

Caplyta carries a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis and an increased risk for suicidal thoughts and behaviors in children and young adults.

Increased risk of death in elderly people with dementia-related psychosis. 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 the treatment of people with dementia-related psychosis.

Increased risk of suicidal thoughts and actions. Caplyta and antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

Caplyta can also cause the following serious side effects.

Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Caplyta is not approved for the treatment of people with dementia-related psychosis.

Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

Uncontrolled body movements (tardive dyskinesia). Caplyta may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Caplyta. Tardive dyskinesia may also start after you stop taking Caplyta.

Problems with your metabolism such as:

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 or faint when you rise too quickly from a sitting or lying position after taking Caplyta.

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 fractures or other injuries.

Seizures (convulsions). Caplyta may increase your risk of seizures.

There is a risk that Caplyta may cause difficulty swallowing which can cause food or liquid to get into your lungs. Tell your healthcare provider immediately if this happens.

Problems controlling your body temperature so that you feel too warm.

Some people may be allergic to Caplyta or any of the inactive ingredients in the capsules. Get emergency medical help if you have signs of an allergic reaction to Caplyta such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

This is not a complete list of Caplyta side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use Caplyta if you are allergic to Caplyta, lumateperone, or any of the ingredients in the capsules. Caplyta may also increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Before taking Caplyta, tell your healthcare provider about all your medical conditions, including if you have ever had:

Pregnancy

Caplyta may harm your unborn baby. Taking Caplyta during the last 3 months of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take Caplyta during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Caplyta. Do not stop the medicine without your doctor's advice. If you become pregnant during treatment with Caplyta, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/ clinical-and-research-programs/pregnancyregistry/.

Breastfeeding

Caplyta passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with Caplyta.

Fertility

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

How should I take Caplyta?

Take Caplyta as prescribed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Caplyta dosing information

Usual Adult Dose of Caplyta for Schizophrenia: Caplyta 42 mg orally once a day

Usual Adult Dose of Caplyta for Bipolar 1 or 2 Disorder: Caplyta 42 mg orally once a day

The dosage of Caplyta should be reduced in moderate to severe liver disease to Caplyta 21 mg once daily.

Vraylar, Cobenfy, quetiapine, lamotrigine, aripiprazole, Abilify, olanzapine, risperidone, Seroquel, lithium

What happens if I miss a dose of Caplyta?

Take Caplyta as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Caplyta?

Caplyta may make it difficult for you to control your body temperature so that you feel too warm. Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Caplyta can cause sleepiness and drowsiness, make you feel tired, or make it difficult for you to think and do normal activities. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can also cause falls, accidents, or severe injuries.

What other drugs will affect Caplyta?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with lumateperone, especially:

This list is not complete and many other drugs may interact with lumateperone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Does Caplyta interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Caplyta storage

Store Caplyta at room temperature away from moisture and heat.

Caplyta ingredients

Active ingredient in Caplyta: lumateperone.
Inactive ingredients in Caplyta: croscarmellose sodium, gelatin, magnesium stearate, mannitol, and talc. Colorants include FD& C blue #1 and red #3 (42 mg), FDA/E172 black iron oxide, FDA/E172 red iron oxide and FD& C red #3 (10.5 mg), and titanium dioxide (42 mg, 21 mg, and 10.5 mg).

Available as Caplyta 42 mg, Caplyta 21 mg, and Caplyta 10.5 mg.

Who makes Caplyta

Intra-Cellular Therapies Inc. manufactures Caplyta.

Popular FAQ

When should I take Caplyta?

Caplyta (lumateperone) should be taken once a day with or without food. The recommended dosage is one 42mg capsule a day. Caplyta can cause somnolence and sedation, but these side effects are reported less frequently when Caplyta is taken in the evening.

What is the mechanism of action for Caplyta?

Caplyta (lumateperone) is thought to work by changing the activity of certain chemicals called neurotransmitters in the brain. These neurotransmitters include dopamine, glutamate, and serotonin. Continue reading

Caplyta savings card: Do I qualify and how much can I save?

To be eligible for the Caplyta Savings Card, you must be 18 years of age or older, have a prescription for Caplyta, and have private commercial insurance. It cannot be used with federal or state health programs. If you qualify, you may pay as little as $0 for the first two fills of a 30-day supply of Caplyta, up to the maximum lifetime benefit which is based on the current list price of a 30-day supply. After that, you pay $15 for fills up to a 90-day supply (maximum benefit $600). Continue reading

How long does it take Caplyta to work?

Patient with schizophrenia started to show improved Positive and Negative Syndrome Scale (PANSS) total scores after one week of treatment with Caplyta (lumateperone), according to the results of a phase III trial. PANSS is a scale used to measure the severity of schizophrenia symptoms. Symptoms continue to improve the longer you take the drug. Continue reading

Does Caplyta cause weight gain?

Caplyta (lumateperone) treatment is not associated with the weight gain that some other antipsychotic drugs are. Caplyta is an atypical antipsychotic that is used to treat schizophrenia and bipolar depression in adults. Continue reading

View more FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.