Olanzapine and Samidorphan
Olanzapine and samidorphan is a combination antipsychotic used to treat schizophrenia and bipolar I disorder in adults.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important warning: Lybalvi should NOT be used to treat behavior or psychosis related to dementia. Elderly patients with dementia-related psychosis who take antipsychotic drugs — including Lybalvi — have a significantly higher risk of death compared to those taking a placebo. Most of these deaths were due to heart-related causes or infections such as pneumonia. Lybalvi is not approved for this use. If you have a loved one with dementia, talk to their doctor about safer options for managing behavioral symptoms.
📖 Olanzapine and Samidorphan: Patient Information Guide
A plain-language walkthrough of Olanzapine and Samidorphan — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Lybalvi (olanzapine/samidorphan) is a combination medicine approved for adults with serious psychiatric conditions.
- Schizophrenia in adults — Lybalvi is approved for ongoing treatment
- Bipolar I disorder, manic or mixed episodes — Lybalvi can be used alone (monotherapy) or added to lithium or valproate for acute episode treatment in adults
- Bipolar I disorder, maintenance — Lybalvi is approved as long-term monotherapy to help prevent recurrence of episodes in adults
⚙️How it works▾
Lybalvi contains two medicines working together. Olanzapine is an atypical antipsychotic; it's thought to work by blocking dopamine and serotonin type 2 (5HT2) receptors — chemical signaling pathways in the brain linked to psychosis and mood instability. Samidorphan works by blocking opioid receptors (mu, kappa, and delta subtypes), acting as an opioid antagonist. The exact reasons why blocking these receptors helps with schizophrenia or bipolar symptoms aren't fully understood, but these actions on brain chemistry are believed to underlie the medicine's benefits.
💊How it's taken▾
Lybalvi is taken orally as a single tablet once a day, with or without food — there is no clinically meaningful food effect. The tablet should never be split or combined with other Lybalvi strengths to reach a dose. Your prescriber will set your starting dose and may adjust it gradually based on how you respond and how well you tolerate the medicine.
- Take it at the same time each day as directed by your prescriber
- Do not divide tablets or mix strengths
- If you have a higher risk of low blood pressure or are sensitive to olanzapine, your prescriber may start you at a lower dose and increase it slowly
🤒Side effects — in detail▾
The most common side effects reported with Lybalvi include:
- Weight gain
- Sleepiness or drowsiness (somnolence)
- Dry mouth
- Headache
- Dizziness
- Increased appetite
- Constipation
- Sedation
- Elevated blood insulin levels
More serious reactions — including uncontrolled muscle movements (tardive dyskinesia), high fever with muscle stiffness (neuroleptic malignant syndrome), significant blood sugar changes, and dangerous drops in blood pressure — require prompt medical attention. Contact your doctor or go to the ER if these occur.
⚠️Warnings & precautions▾
- Dementia-related psychosis: Lybalvi is NOT approved for behavioral symptoms of dementia — elderly patients with dementia given antipsychotics have a significantly higher risk of death.
- Opioid interactions: Lybalvi is contraindicated with opioids. It can trigger severe, life-threatening opioid withdrawal in dependent patients. Attempting to override Lybalvi's opioid blockade with high doses of opioids can be fatal.
- Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction — symptoms include high fever, severe muscle rigidity, confusion, and irregular heartbeat. Stop Lybalvi immediately and seek emergency care.
- Metabolic changes: Lybalvi can cause weight gain, high blood sugar (hyperglycemia), and abnormal lipid (cholesterol/triglyceride) levels. Regular lab monitoring is important.
- Tardive dyskinesia: Uncontrolled, repetitive muscle movements that can become permanent — risk increases with longer use and higher doses.
- Low blood pressure (orthostatic hypotension): Especially when standing up; risk is greatest when starting or increasing the dose.
- Falls: Drowsiness, dizziness, and low blood pressure can increase the risk of falling, especially in older adults.
- Low white blood cell count: Monitor for signs of infection; patients with prior low counts need closer blood monitoring.
🔀What it interacts with▾
Lybalvi has several important drug and substance interactions to be aware of:
- Opioids — completely contraindicated; can cause severe withdrawal or fatal overdose; must be opioid-free before starting
- Alcohol and CNS depressants (e.g., diazepam, sleep aids, sedatives) — increase the risk of orthostatic hypotension (dangerous blood pressure drop)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) — lower blood levels of both olanzapine and samidorphan, reducing effectiveness; not recommended
- Strong CYP1A2 inhibitors (e.g., fluvoxamine) — raise olanzapine levels, increasing side effect risk
- CYP1A2 inducers (e.g., tobacco smoke) — lower olanzapine levels, possibly reducing effectiveness
- Blood pressure medications (antihypertensives) — Lybalvi can amplify blood pressure-lowering effects; monitoring required
- Levodopa and dopamine agonists (Parkinson's medications) — Lybalvi may block their effects; combination not recommended
- Anticholinergic drugs (certain bladder, stomach, or allergy medicines) — combined use can impair gut movement and cause serious GI problems
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take Lybalvi if you currently use opioids or are in opioid withdrawal — it is contraindicated in these situations
- You must be opioid-free for at least 7 days (short-acting opioids) or 14 days (long-acting opioids) before starting Lybalvi
- Tell your doctor about any heart disease, history of heart attack, low blood pressure, or fainting episodes
- Tell your doctor if you have diabetes or a family history of diabetes — Lybalvi can raise blood sugar
- Tell your doctor if you have a history of seizures
- Tell your doctor if you have had urinary retention, enlarged prostate, constipation, or bowel problems
- Tell your doctor if you have a low white blood cell count or a history of drug-related blood count problems
- Pregnancy: Babies born to mothers who took Lybalvi in the third trimester may experience muscle movement problems or withdrawal symptoms — discuss risks and benefits with your doctor; a pregnancy registry is available (1-866-961-2388)
- Breastfeeding: Both olanzapine and samidorphan pass into breast milk; monitor infants for sedation, irritability, poor feeding, or abnormal muscle movements
- Children and teens: Lybalvi's safety and effectiveness have not been established in patients under 18
- Older adults: Lybalvi is not approved for dementia-related psychosis; elderly patients have a higher risk of death with antipsychotics used for that purpose
- End-stage kidney disease: Use of Lybalvi is not recommended in patients with end-stage renal disease
🚑If you take too much▾
Taking too much Lybalvi can cause serious symptoms, including unresponsiveness, agitation, rapid heartbeat, muscle movement problems, and in severe cases, breathing problems, heart rhythm issues, or coma. If an overdose is suspected, call Poison Control at 1-800-222-1222 immediately or go to the nearest emergency room. There is no specific antidote for Lybalvi — treatment is supportive care under close medical supervision.
📡Pharmacodynamics — effects in the body▾
Olanzapine binds strongly to multiple brain receptors — including serotonin, dopamine, histamine, and adrenergic receptors — which accounts for both its antipsychotic effects and some of its side effects like drowsiness and blood pressure changes. Samidorphan binds to mu-, kappa-, and delta-opioid receptors, acting as an opioid blocker. At doses studied, Lybalvi does not cause any clinically meaningful prolongation of the QTc interval (a measure of heart rhythm) — meaning it does not appear to meaningfully increase the risk of a dangerous heart arrhythmia at recommended doses.
🔬Pharmacokinetics — how your body processes it▾
After taking Lybalvi once daily by mouth, both olanzapine and samidorphan are absorbed and reach stable blood levels (steady state) within about 7 days. Olanzapine has a long half-life of 35–52 hours, meaning it stays in your system for an extended time; samidorphan has a shorter half-life of 7–11 hours. Olanzapine is primarily broken down by liver enzymes (UGT1A4 and CYP1A2), while samidorphan is mainly metabolized by CYP3A4. Both are excreted mostly through the urine and, to a lesser extent, the stool. Food does not have a clinically significant effect on how either drug is absorbed.
📦How to store it▾
Store at room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) . protect from moisture.
📄 Written from Olanzapine and Samidorphan’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 →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Olanzapine and Samidorphan — the kind of thing our pharmacy team would talk through with you at the counter.
Why does Lybalvi have two drugs in it? What does each one do? ▾
Can I take any pain medications while I'm on Lybalvi? ▾
I gained a lot of weight — is that from this medication? ▾
What should I watch for that would mean I need to call my doctor or go to the ER? ▾
Is it safe to take Lybalvi if I'm pregnant or trying to get pregnant? ▾
Does it matter what time of day I take Lybalvi, or can I take it with food? ▾
Is Olanzapine and Samidorphan available over the counter? ▾
When was Olanzapine and Samidorphan first available? ▾
💬 Answers drafted from Olanzapine and Samidorphan’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 →
🧰 Keep exploring
💊 How Olanzapine and Samidorphan comes
Olanzapine and Samidorphan 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.
Tablet
How this form is used
- Lybalvi tablets are used to treat schizophrenia in adults
- Lybalvi tablets are used to treat bipolar I disorder (manic or mixed episodes) in adults, as monotherapy or with lithium or valproate
- Lybalvi tablets are used as long-term maintenance monotherapy for bipolar I disorder in adults
- Lybalvi tablets are taken by mouth once daily, with or without food
- Lybalvi tablets should be swallowed whole — do not divide, split, or combine different strengths
- Lybalvi tablets should not be started until you have been opioid-free for at least 7 days (short-acting opioids) or 14 days (long-acting opioids)
📊 Olanzapine and Samidorphan across the U.S. market
How Olanzapine and Samidorphan 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.
📈 How widely Olanzapine and Samidorphan is used
A general measure of how commonly Olanzapine and Samidorphan 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 Olanzapine and Samidorphan 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 Olanzapine and Samidorphan prescribed? Of the 1,596 medications we measure, Olanzapine and Samidorphan ranks #477 by Medicaid prescriptions — more than 70% of them.
Utilization by Olanzapine and Samidorphan 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.
olanzapine 10 MG / samidorphan 10 MG Oral Tablet Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570399
olanzapine 20 MG / samidorphan 10 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570405
olanzapine 5 MG / samidorphan 10 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570392
olanzapine 15 MG / samidorphan 10 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570402
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 Olanzapine and Samidorphan, 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 4 of 20 listed Olanzapine and Samidorphan NDCs with Medicaid activity.
🔍 Compare Olanzapine and Samidorphan products
A representative set of FDA-listed product records for Olanzapine and Samidorphan — 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 |
|---|---|---|---|---|
| 💊Tablet | ||||
| OLANZAPINE 5 mg/1; SAMIDORPHAN L-MALATE 10 mg | — | Alkermes, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| OLANZAPINE 5 mg/1; SAMIDORPHAN L-MALATE 10 mg | Oral | Alkermes, Inc. | NDA | View NDC → |
| OLANZAPINE 10 mg/1; SAMIDORPHAN L-MALATE 10 mg | Oral | Alkermes, Inc. | NDA | View NDC → |
| OLANZAPINE 10 mg/1; SAMIDORPHAN L-MALATE 10 mg | — | Alkermes, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| OLANZAPINE 15 mg/1; SAMIDORPHAN L-MALATE 10 mg | Oral | Alkermes, Inc. | NDA | View NDC → |
| OLANZAPINE 15 mg/1; SAMIDORPHAN L-MALATE 10 mg | — | Alkermes, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| OLANZAPINE 20 mg/1; SAMIDORPHAN L-MALATE 10 mg | Oral | Alkermes, Inc. | NDA | View NDC → |
| OLANZAPINE 20 mg/1; SAMIDORPHAN L-MALATE 10 mg | — | Alkermes, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 5; 10 mg/1; mg | Oral | Alkermes, Inc. × 2 listings | NDA | View NDC → |
| 10; 10 mg/1; mg | Oral | Alkermes, Inc. × 2 listings | NDA | View NDC → |
| 15; 10 mg/1; mg | Oral | Alkermes, Inc. × 2 listings | NDA | View NDC → |
| 20; 10 mg/1; mg | Oral | Alkermes, Inc. × 2 listings | NDA | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Olanzapine and Samidorphan NDCs →
📈 What people report — real-world data (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 Olanzapine and Samidorphan — a signal of what to watch for, not proof the drug caused it.
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 Olanzapine and Samidorphan 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.
🏛️ The road to your pharmacy
How Olanzapine and Samidorphan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 2562108 1 dose form · 4 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2570391In current FDA listingsClinical drug / strength (SCD) olanzapine 10 MG / samidorphan 10 MGRxCUI 2570399olanzapine 15 MG / samidorphan 10 MGRxCUI 2570402olanzapine 20 MG / samidorphan 10 MGRxCUI 2570405olanzapine 5 MG / samidorphan 10 MGRxCUI 2570392
Look up RxCUI 2562108 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.
📦 Supply & shortage status
Whether Olanzapine and Samidorphan 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
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. Alkermes, 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.