Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

David Snyder, PharmD, BCPP, is a board-certified clinical pharmacist and psychopharmacology expert at McLean Hospital in Belmont, Massachusetts.

Caplyta should not be used in people with dementia-related psychosis (losing touch with reality due to confusion and memory loss). Older adults with dementia-related psychosis who take antipsychotic medications have a higher risk of death. Antidepressants have been shown to increase the risk of suicidal thoughts and behavior in children and young adults. People of any age who take Caplyta should be monitored for changes in mood and behavior. However, Caplyta is not approved for use in children or adolescents under age 18.

Caplyta (lumateperone ) is an oral prescription drug used to treat schizophrenia or bipolar depression. It is available as a capsule that is taken by mouth.

Caplyta is in a drug class called atypical antipsychotics, or second-generation antipsychotics. Second-generation antipsychotics have fewer side effects than older or first-generation antipsychotics. The exact way Caplyta works is not entirely understood, but it is thought to act on dopamine and serotonin receptors in the brain.

Brand Name(s): Caplyta

Therapeutic Classification: Atypical (second-generation) antipsychotic

Controlled Substance: N/A

Dosage Form(s): Capsule

The Food and Drug Administration (FDA) approved Caplyta to treat adults with schizophrenia. Schizophrenia is a condition that affects a person's ability to behave, think, and feel clearly.

Caplyta can also be used to treat depressive episodes (the lows) related to bipolar I or II disorder in adults. This is called bipolar depression. For bipolar depression, Caplyta can be taken alone or in combination with other medications such as lithium or valproate.

Before starting your treatment with Caplyta, read your prescription label and the information leaflet that comes with your prescription. If you have any questions, don't hesitate to ask your healthcare provider. It's important to take this drug exactly as prescribed, usually once per day.

There are a few important things to keep in mind while using Caplyta:

Store Caplyta at room temperature, away from heat, direct light, and moisture. Keep this medication in its original labeled container and out of the reach and sight of children and pets. Keep the bottle tightly closed when not in use.

Healthcare providers may prescribe this medication for off-label uses, meaning for conditions not specifically indicated by the FDA. In some cases, Caplyta may be used for other mental health conditions.

You may start to notice an improvement in symptoms within a week or two, but it may take up to two or three months to see the full effect of Caplyta. Antipsychotic medication is usually required as a lifelong treatment.

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Like other medications, Caplyta can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

The most common side effects of Caplyta are:

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

Long-term or delayed side effects are possible with Caplyta treatment.

Tardive dyskinesia (TD) is a common side effect that occurs when antipsychotics are taken for a long time. Although TD is less likely to occur with new antipsychotics, it is possible.

Symptoms of TD can include:

Your healthcare provider will have you regularly complete an Abnormal Involuntary Movement Scale (AIMS).

Second-generation antipsychotics, including Caplyta, can also increase the risk of high blood sugar (and diabetes), weight gain, and high cholesterol. Your healthcare provider will monitor you for these complications.

Caplyta may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Older adults (65 and older) with dementia-related psychosis (losing touch with reality due to confusion and memory loss) should not use Caplyta. Older adults should consult with their healthcare provider before taking Caplyta. Caplyta is not approved for use in children or adolescents under 18 years.

When deciding whether to prescribe Caplyta, your healthcare provider may consider certain circumstances or health conditions that may warrant a treatment modification:

If you miss a dose of Caplyta, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing time. Do not take two doses to make up for a missed dose.

Do not take more than the prescribed amount of your medication. You may need supportive care and monitoring by a healthcare provider if you overdose on Caplyta.

If you think you or someone else may have overdosed on Caplyta, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Caplyta, call 911 immediately.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.

Check with your doctor right away if you have any of the following symptoms while taking this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Lumateperone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause some people to become dizzy, drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Avoid activities involving high temperature or humidity. This medicine may reduce your body's ability to adjust to the heat.

Tell your doctor if you are pregnant or planning to become pregnant during treatment with this medicine. This medicine may cause extrapyramidal or withdrawal symptoms (eg, agitation, feeding disorder, tremor, unusual drowsiness) in the baby during the third trimester.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Caplyta is not appropriate for everyone. You should not take this medication if you are allergic to lumateperone or any of the inactive ingredients in Caplyta. 

Other people who should not take Caplyta include:

In some cases, Caplyta may be prescribed with caution only if the healthcare provider determines it is safe. This includes:

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines and vitamins or supplements. 

While taking Caplyta, do not drink alcohol or use illegal drugs, as this can make side effects worse.

Caplyta should not be taken with drugs or substances known as moderate to strong CYP3A4 inhibitors, because these drugs increase Caplyta levels, meaning there is a higher chance of side effects and toxicity with Caplyta.

Examples of moderate to strong CYP3A4 inhibitors include:

On the other hand, drugs known as CYP3A4 inducers cause lower levels of Caplyta in the body, making it less effective. These drugs and supplements should not be taken with Caplyta.

Examples of CYP3A4 inducers include:

Other drug interactions may occur with Caplyta. Consult your healthcare provider for a complete list of drug interactions.

Caplyta is a second-generation antipsychotic and can be taken alone or in combination with other medication such as lithium or valproate.

Examples of other drugs in the second-generation antipsychotic drug class include:

First-generation antipsychotics are prescribed less often due to their more severe movement-related side effects. Examples of first-generation antipsychotics include:

Caplyta is a second-generation antipsychotic that can be used to treat schizophrenia or bipolar depression in adults.

Caplyta's mechanism of action (the way it works) is not fully understood. It is thought to act on serotonin and dopamine receptors in the brain.

Caplyta interacts with various drugs that affect an enzyme called CYP3A4. Some drugs (and grapefruit juice) cause increased Caplyta levels, which can lead to a higher chance of side effects and toxicity. Other drugs can decrease Caplyta levels, making Caplyta less effective. See the drug interaction section for a list of examples of drugs that interact with Caplyta. Caplyta also should not be combined with alcohol or illegal drugs.

Symptoms may start to improve within a week or two. However, it may take up to two or three months to notice the full effect of Caplyta. Antipsychotic medication is usually required as a lifelong treatment.

Common side effects include sleepiness, fatigue, headache, dizziness, dry mouth, appetite loss, upper respiratory infection, and stomach problems. It is also common to have high cholesterol, increased levels of creatinine phosphokinase, and increased liver enzyme levels. Another common side effect is impaired body temperature regulation, where the body feels warm and has difficulty cooling off.

Antipsychotic treatment is usually required for a lifetime. However, that does not necessarily mean that you will take one drug or another forever. In some cases, your medication regimen may need to be changed or adjusted. Follow your healthcare provider's instructions for use and do not skip doses or stop taking Caplyta unless you are told to.

Before taking any new medication, discuss your medical history and current drug regimens with your healthcare provider. Check with your healthcare provider before taking any new medications, including prescription and over-the-counter drugs or supplements.

Second-generation antipsychotics such as Caplyta can cause metabolic changes, including weight gain, high cholesterol, and high blood sugar. It may be helpful to consult with a registered dietician or speak with your healthcare provider about diet and exercise.

Caplyta is taken once daily, and adhering to your medication schedule is important. You can use a weekly pill organizer to keep track of your medications, which can be especially helpful if you are on multiple regimens. A reminder on your phone or an app can also help you remember to take your medication(s).

Tell your family, friends, and caregivers to let you know if they notice any changes in your mood or behavior. If you or anyone else notices a change in mood or behavior, notify your healthcare provider immediately.

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Food and Drug Administration. Caplyta label.

Greenwood J, Acharya RB, Marcellus V, et al. Lumateperone: a novel antipsychotic for schizophrenia. Annals of Pharmacotherapy. 2020. doi:10.1177/1060028020936597

National Alliance on Mental Illness (NAMI). Lumateperone (Caplyta).

Edinoff A, Wu N, deBoisblanc C, et al. Lumateperone for the treatment of schizophrenia. Psychopharmacol Bull. 2020;50(4):32-59.

National Alliance on Mental Illness (NAMI). Lumateperone (Caplyta).

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