Lumateperone
Lumateperone is an atypical antipsychotic used in adults to treat schizophrenia, bipolar depression, and (along with an antidepressant) major depressive disorder.
Built from the FDA-approved label, dated Jun 20, 2025 · How this page is built
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Older adults with dementia-related psychosis who take antipsychotic medicines like this one have a higher risk of death. Caplyta is not approved for dementia-related psychosis. Most deaths in studies were from heart-related causes (such as heart failure or sudden death) or infections (such as pneumonia).
The second warning is about suicidal thoughts and behaviors. Antidepressants raised this risk in children and young adults in short-term studies. Caplyta has not been shown to be safe or effective in children. Watch closely for worsening mood or new suicidal thoughts, especially in the first few months and after dose changes. Family and caregivers should tell the doctor about any behavior changes.
⚡ Quick answers about Lumateperone
What is this medicine for?
Caplyta (lumateperone) treats schizophrenia in adults. It also treats depressive episodes of bipolar I or II disorder, alone or with lithium or valproate.
Read the full answer →How do I take it?
Take one capsule by mouth once a day. You can take it with or without food. Follow your prescriber's directions and the label.
See it in the FAQ →What side effects should I expect?
The most common are sleepiness, dizziness, dry mouth, nausea, headache, and fatigue. Use caution driving until you know how it affects you. Call me or your doctor if side effects are bothersome or worrying.
See it in the FAQ →When should I call my doctor right away?
Call right away for new or worse depression or thoughts of suicide. Also call for high fever with stiff muscles and confusion, uncontrolled movements, fainting, seizures, or signs of infection.
Read the full answer →🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →📖 Lumateperone: Patient Information Guide
A plain-language walkthrough of Lumateperone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Lumateperone is used for
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Lumateperone is an atypical antipsychotic approved for adults for these uses:
- Schizophrenia
- Depressive episodes of bipolar I or II disorder (bipolar depression), as monotherapy or added to lithium or valproate
- Major depressive disorder (MDD), as add-on therapy with an antidepressant
These uses apply to Caplyta capsules.
How Lumateperone works
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The exact way lumateperone works for these conditions is unknown. It may work by blocking serotonin 5-HT2A receptors and partly activating dopamine D2 receptors in the brain. Both chemicals help regulate mood and thinking.
How Lumateperone is taken (dosage)
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Caplyta is taken as a capsule by mouth once daily, with or without food. No gradual dose increase is needed. Your prescriber may use a lower dose if you have moderate or severe liver impairment or take certain interacting medicines. Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Lumateperone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
Recommended oral dosage of CAPLYTA is 42 mg once daily with or without food.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended oral dosage of CAPLYTA is 42 mg once daily with or without food. ( 2.1 ) Moderate hepatic impairment or severe hepatic impairment: Recommended dosage is 21 mg once daily. ( 2.3 , 8.6 ) 2.1 Recommended Dosage The recommended CAPLYTA dosage is 42 mg administered orally once daily with or without food. Dose titration is not needed. 2.2 Dosage Recommendations for Concomitant Use with Moderate or Strong CYP3A4 Inhibitors The recommended CAPLYTA dosage in patients who receive [see Drug Interactions ( 7.1 ) ] : Strong CYP3A4 inhibitors is 10.5 mg once daily. Moderate CYP3A4 inhibitors is 21 mg once daily. 2.3 Dosage Recommendations for Patients with Hepatic Impairment For patients with moderate hepatic impairment (HI) (Child-Pugh class B) or severe HI (Child-Pugh class C), the recommended CAPLYTA dosage is 21 mg once daily [see Use in Specific Populations (8.6) ] . The recommended CAPLYTA dosage in patients with mild HI is the same as those with normal hepatic function.
Read the full Dosage and Administration section on DailyMed →
Lumateperone side effects in detail
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Common side effects
- Sleepiness or sedation
- Dizziness
- Dry mouth
- Nausea
- Headache
- Fatigue
- Diarrhea
- Vomiting
When to get medical help
- Call your doctor right away if you have new or worsening depression, or any thoughts of suicide or self-harm.
- Get urgent help for high fever, stiff muscles, confusion, or unstable heart rate and blood pressure. These can be signs of neuroleptic malignant syndrome.
- Tell your doctor if you notice uncontrolled movements of the face, tongue, or body (tardive dyskinesia).
- Report fainting, or dizziness when standing up.
- Report signs of infection such as fever or sore throat, since this drug can lower white blood cell counts.
- Seek help for a seizure, trouble swallowing, or a rash, itching, or hives.
- Tell your doctor about very high thirst or urination, which may signal high blood sugar.
Common side effects in studies included:
- Sleepiness or sedation
- Dizziness
- Dry mouth
- Nausea
- Headache
- Fatigue
- Diarrhea
- Vomiting
Contact your doctor about serious reactions such as suicidal thoughts, fever with stiff muscles, uncontrolled movements, fainting, seizures, or signs of infection.
Lumateperone warnings and precautions
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- Higher risk of death in older adults with dementia-related psychosis, including stroke risk. It is not approved for this use.
- Suicidal thoughts and behaviors, especially in children and young adults.
- Neuroleptic malignant syndrome, a potentially fatal reaction.
- Tardive dyskinesia, which can become irreversible.
- Metabolic changes: high blood sugar, cholesterol changes, weight gain.
- Low white blood cell counts.
- Low blood pressure and fainting, seizures, and impaired thinking or movement.
Lumateperone interactions: what it interacts with
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Some medicines change lumateperone levels in your body.
- Strong CYP3A4 inhibitors: raise levels, so a much lower dose is used.
- Moderate CYP3A4 inhibitors: raise levels, so a lower dose is used.
- CYP3A4 inducers: lower levels a lot, so avoid together.
- Serotonin reuptake inhibitors: may increase risks like serotonin syndrome and low sodium.
Interactions listed in the FDA-approved label
From the Lumateperone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
7 DRUG INTERACTIONS CYP3A4 inducers: Avoid concomitant use with CAPLYTA. ( 7.1 ) Strong CYP3A4 inhibitors: Recommended dosage is 10.5 mg once daily.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP3A4 inducers: Avoid concomitant use with CAPLYTA. ( 7.1 ) Strong CYP3A4 inhibitors: Recommended dosage is 10.5 mg once daily. ( 2.2 , 7.1 ) Moderate CYP3A4 inhibitors: Recommended dosage is 21 mg once daily. ( 2.2 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with CAPLYTA Clinically important drug interactions with CAPLYTA are presented in Table 6. Table 6: Clinically Important Drug Interactions with CAPLYTA CYP3A4 Inducers* Prevention or Management Avoid concomitant use of CAPLYTA with CYP3A4 inducers . Clinical Impact Concomitant use of CAPLYTA with CYP3A4 inducers decreases the exposure of lumateperone [see Clinical Pharmacology ( 12.3 ) ]. Moderate or Strong CYP3A4 Inhibitors* Prevention or Management Reduce the CAPLYTA dosage when used concomitantly with moderate or strong CYP3A4 inhibitors [see Dosage and Administration ( 2.2 ) ]. Clinical Impact Concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors increases lumateperone exposure [see Clinical Pharmacology ( 12.3 ) ] , which may increase the risk of adverse reactions. Serotonin Reuptake Inhibitors Prevention or Management Increased monitoring for SRI- associated adverse reactions is recommended. Clinical Impact Although no clinically significant drug interactions with adjunctive SSRI/SNRIs in MDD were observed in CAPLYTA clinical trials, CAPLYTA’s moderate serotonin transporter (SERT) activity may increase the risk of SRI-associated adverse reactions (e.g., serotonin syndrome, hyponatremia). * See www.fda.gov/CYPandTransporterInteractingDrugs for examples of CYP3A4 Inducers and Moderate or Strong CYP3A4 Inhibitors
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Lumateperone
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- Do not use if you are allergic to lumateperone or any capsule ingredient.
- Moderate or severe liver impairment: a lower dose is recommended.
- Pregnancy: late-pregnancy use may cause withdrawal or movement symptoms in newborns. A pregnancy registry exists.
- Breastfeeding: small amounts pass into milk.
- Not established for children.
- Older adults: risk of tardive dyskinesia is highest in elderly people, especially women, and the label lacked enough data on adults 65 and older.
- Animal studies suggest possible effects on fertility.
Lumateperone overdose: if you take too much
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No specific antidote is known. Treatment is supportive care with close medical monitoring. Call Poison Help at 1-800-222-1222 or seek emergency care.
Pharmacodynamics: what Lumateperone does in the body
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Lumateperone binds strongly to serotonin 5-HT2A receptors and moderately to dopamine D2 receptors. It also binds to other receptors and the serotonin transporter. In one heart-rhythm study, a dose three times the recommended amount caused a larger change in the QT interval than the usual dose.
Pharmacokinetics: how your body processes Lumateperone
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After a capsule is taken, peak levels occur in about 1 to 2 hours, and steady state is reached in about 5 days. Only a small share of each dose reaches the bloodstream. The drug is extensively broken down by the body, and the half-life is about 18 hours. Most of it leaves in the urine and feces. Levels are higher in moderate or severe liver impairment.
How to store Lumateperone
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Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Lumateperone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Lumateperone
183 supplements and herbal products have documented interactions with Lumateperone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 142
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Lumateperone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lumateperone — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take it with my other medicines?
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Is it safe in pregnancy or for older adults?
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Is Lumateperone available over the counter?
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When was Lumateperone first available?
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Who makes Lumateperone?
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💬 Answers drafted from Lumateperone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Lumateperone on HelloPharmacist
💊 Lumateperone forms and strengths (how it comes)
Lumateperone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Caplyta is used in adults for schizophrenia.
- Caplyta is used in adults for bipolar I or II depression, alone or with lithium or valproate.
- Caplyta is used with an antidepressant in adults for major depressive disorder.
- Caplyta is taken by mouth once daily, with or without food.
- Caplyta does not need dose titration.
- Caplyta dosing is lowered for moderate or severe liver impairment and with certain CYP3A4 inhibitors.
📊 Lumateperone on the U.S. market: products, makers and brands
How Lumateperone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
9 companies list 19 Lumateperone product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2019. Brand names on the directory include Caplyta; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Lumateperone is used (Medicaid data)
A general measure of how commonly Lumateperone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lumateperone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lumateperone prescribed? Of the 1,599 medications we measure, Lumateperone ranks #358 by Medicaid prescriptions — more than 78% of them.
Utilization by Lumateperone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lumateperone 42 MG Oral Capsule Most dispensed
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2275607
lumateperone 21 MG Oral Capsule
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2607533
lumateperone 10.5 MG Oral Capsule
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2607529
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lumateperone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 10 listed Lumateperone NDCs with Medicaid activity.
🔍 Compare Lumateperone products
A representative set of FDA-listed product records for Lumateperone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 10.5 mg | Oral | Intra-Cellular Therapies, Inc × 3 listings | NDA | View NDC → |
| 21 mg | Oral | Intra-Cellular Therapies, Inc × 3 listings | NDA | View NDC → |
| 42 mg | Oral | Intra-Cellular Therapies, Inc × 3 listings | NDA | View NDC → |
| 42 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 42 mg | Oral | Remedyrepack Inc. × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Dasami Lab Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr. Reddy's Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Lonza AG × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Maithri Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Siegfried Evionnaz SA | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zhejiang Ausun Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Lumateperone NDCs →
📈 Lumateperone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lumateperone — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Lumateperone are dizziness, nausea, headache; about 28% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lumateperone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Lumateperone FDA approval history
How Lumateperone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Lumateperone was first approved by the FDA in 2019 (Brand: CAPLYTA · Intra-cellular). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
🚨 Lumateperone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
No recall of any Lumateperone product is on record in the FDA enforcement database.
✅No recalls found for Lumateperone in the FDA databaseSource: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2275602 1 dose form · 3 strengths
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Dose form (SCDF) Oral Capsule RxCUI 2275606In current FDA listings
Look up RxCUI 2275602 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Lumateperone supply and shortage status
Whether Lumateperone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Lumateperone brand names
Lumateperone is sold under one brand name in the FDA directory — Caplyta. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Lumateperone: manufacturers and labelers
9 companies list Lumateperone products with the FDA. By number of product records, the largest are Intra-Cellular Therapies, Inc, Lonza AG, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Lumateperone drug class (RxNorm)
Lumateperone belongs to the Atypical Antipsychotic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Lumateperone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Intra-Cellular Therapies, Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.