Caplyta (Lumateperone) - Oral

Warning:

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.

What Is Caplyta?

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.

Drug Facts

Generic Name: Lumateperone

Brand Name(s): Caplyta

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Atypical (second-generation) antipsychotic

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Lumateperone

Dosage Form(s): Capsule

What Is Caplyta Used For?

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.

How to Take Caplyta

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:

  • It may cause you to feel drowsy. Make sure to avoid driving or using machinery until you know how you will feel after taking it. Alcohol can increase the drowsiness caused by Caplyta, so you may not want to drink alcohol while using this medication.
  • Be careful not to become too hot or dehydrated. Drink plenty of water and try to avoid spending long periods in the sun. If it's hot outside, wear lighter clothing to keep cool and avoid excessive exercise.
  • Grapefruit can interact with Caplyta. Do not drink grapefruit juice or eat grapefruit while on this medication.
  • Tell your healthcare provider if you become sick with diarrhea or are vomiting.

Storage

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.

Off-Label Uses

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.

How Long Does Caplyta Take To Work?

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.

What Are the Side Effects of Caplyta?

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.

Common Side Effects

The most common side effects of Caplyta are:

  • Excess sleepiness/tiredness
  • Stomach problems such as stomach pain, nausea, vomiting, and diarrhea
  • Headache
  • High cholesterol
  • Dizziness
  • Dry mouth
  • Appetite loss
  • Upper respiratory infection
  • Impaired body temperature regulation (the body feels warm and has trouble cooling down)
  • Increased levels of liver enzymes
  • Increased levels of creatinine phosphokinase, which can indicate a life-threatening condition called neuroleptic malignant syndrome (NMS)

Severe Side Effects

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:

  • Hypersensitivity reaction or anaphylaxis: Symptoms can include rash, hives, swelling around the lips, tongue, and face, difficulty breathing, and require emergency medical attention. 
  • Suicidal thoughts and behavior: Call your healthcare provider immediately if you have mood and behavior changes. Your friends, family, and/or caregivers can also monitor you for changes in mood and behavior, such as depression, anxiety, agitation, irritability, panic attack, or thoughts about suicide.
  • Stroke or mini-stroke: Get emergency medical help if you have symptoms of face drooping or numbness, especially on one side; trouble with speech; or arm weakness or numbness.
  • Fainting: Notify your healthcare provider if fainting occurs during treatment with Caplyta.
  • Orthostatic hypotension: This is a drop in blood pressure when you stand up from a sitting or lying down position. Stand up slowly, and hold onto something sturdy for support. Notify your healthcare provider if you feel lightheaded or dizzy.
  • Neuroleptic malignant syndrome: Also known as NMS, this condition can be fatal, so it requires emergency medical attention. Symptoms may include high fever, irregular pulse, fast heartbeat, sweating, stiff muscles, and anxiety.
  • Muscle-related side effects, including extrapyramidal symptoms (restlessness, tremor, stiffness) and tardive dyskinesia (repetitive, involuntary movements such as eye blinking, grimacing, and lip-smacking) may occur. Report these side effects to your healthcare provider.
  • Dystonia: Symptoms include neck spasms and can progress to throat tightness and difficulty swallowing and/or breathing. Get medical help right away if this occurs.
  • Hyperglycemia (high blood sugar) or diabetes mellitus: Symptoms may include increased thirst and urination, dry mouth, and breath that smells like fruit. Notify your healthcare provider if symptoms occur.
  • Decreased blood cell counts: This can increase the risk of infection and can be life-threatening or cause death in some cases. Your healthcare provider will monitor blood cell counts.
  • Seizures: Caplyta can cause seizures. The risk is higher in people who have a history of seizures.
  • Hyperthermia: Caplyta can cause you to become overheated. Drink plenty of fluids while taking Caplyta and avoid staying out in the sun. If it is hot outside, stay inside as much as possible. Avoid wearing heavy clothes. Discuss exercise options with your healthcare provider, ensuring that you do not exercise excessively, especially in the heat.

Long-Term Side Effects

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:

  • Eye blinking
  • Grimacing
  • Sucking and smacking of the lips

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.

Report Side Effects

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).

Dosage: How Much Caplyta Should I Take?

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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.

  • For oral dosage form (capsules):
    • For schizophrenia:
      • Adults—42 milligrams (mg) once a day with food.
      • Children—Use and dose must be determined by your doctor.

Modifications

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:

  • Liver problems: If you have mild liver issues, classified as Child-Pugh class A, you can take Caplyta without a dosage adjustment. However, people with moderate to severe liver problems (Child-Pugh class B or C) should not be prescribed it.
  • Fertility: Caplyta may affect fertility (the ability to conceive a child) in males and females. Consult your healthcare provider if you plan to become pregnant or try to conceive with a partner.
  • Pregnancy: You will not be prescribed Caplyta if you are in your third trimester, as it can cause problems once the baby is born. Before the third trimester, your healthcare provider may weigh the risks versus benefits of Caplyta use, as no human data is available. There is a pregnancy registry for those who have taken antipsychotics during pregnancy, so you may be asked to enroll in the program.

Missed Dose

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.

Overdose: What Happens If I Take Too Much Caplyta?

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.

What Happens If I 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.

Precautions

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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.

What Are Reasons I Shouldn't Take Caplyta?

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:

  • Older adults with dementia-related psychosis
  • People with moderate to severe liver problems classified as Child-Pugh Class B or C
  • People who are breastfeeding

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

  • Older age (65 and older)
  • Dementia-related psychosis (adults with dementia-related psychosis who are 65 or older should not take Caplyta)
  • Cerebrovascular disease (clotting or blood flow conditions)
  • Heart disease, heart failure, or a history of heart attack
  • Electrolyte abnormalities (altered levels of potassium, magnesium, sodium, or calcium)
  • Heart rate problems or a family history of heart rate problems, such as QT prolongation (an extended interval between heart contractions, which can increase the risk for abnormal heart rhythms and sudden cardiac arrest); torsades de pointes (a very fast heart rhythm that starts in the ventricles of the heart); ventricular arrhythmia (abnormal heartbeat that causes the heart to beat too fast); or bradycardia (slow heart rate)
  • Orthostatic hypotension
  • Hypovolemia (low plasma due to salt and water loss)
  • Dehydration (loss of water)
  • Diabetes or at risk for diabetes
  • Low white blood cell levels or a history of low white blood cell levels from taking certain medications
  • A history of seizures
  • At the risk of aspiration pneumonia (a lung infection caused by food, liquids, saliva, or vomit from the stomach or mouth going into the lungs)
  • Living in a place with high temperatures

What Other Medications May Interact With Caplyta?

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.

What Medications Are Similar?

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:

  • Haldol (haloperidol)
  • Thioridazine
  • Molindone
  • Thiothixene
  • Fluphenazine
  • Trifluoperazine
  • Perphenazine
  • Chlorpromazine

Frequently Asked Questions

  • What is Caplyta used for?

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

  • How does Caplyta work?

    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.

  • What drugs should not be taken with Caplyta?

    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.

  • How long does it take for Caplyta to work?

    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.

  • What are the side effects of Caplyta?

    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.

  • How do I stop taking Caplyta?

    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.

How Can I Stay Healthy While Taking Caplyta?

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.

Medical Disclaimer

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.

7 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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