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Olanzapine / Samidorphan L-Malate

Olanzapine / Samidorphan L-Malate is a combination of an atypical antipsychotic and an opioid blocker, used in adults to treat schizophrenia and bipolar I disorder.

Brand name Lybalvi
Drug class Atypical Antipsychotic
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 5, 2026
Olanzapine / Samidorphan L-Malate at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lybalvi combines olanzapine, a long-used antipsychotic that blocks dopamine and serotonin type 2 signals, with samidorphan, an opioid blocker added to blunt olanzapine's weight gain, for adults with schizophrenia or bipolar I disorder; on the market since about 2021, it is not yet available as a generic. Most people tolerate it much like olanzapine alone, mostly noticing sleepiness, dry mouth, bigger appetite and some weight gain. It must never be combined with opioids (it blocks them and can trigger severe withdrawal), and its boxed warning is a higher risk of death in older adults with dementia-related psychosis, who should not take it. Weight, blood sugar and cholesterol still need regular checks.

Clinical pearls

  • Before the first dose you need to be opioid-free for at least 7 days (short-acting) or 14 days (long-acting).
  • Tell surgeons, dentists and urgent care staff you take Lybalvi, because standard opioid pain relief may not work well.
  • Never take large opioid doses to override the block, and know that tolerance may drop after stopping, risking fatal overdose.
  • Swallow each tablet whole, and never split tablets or combine strengths to make up a dose.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Older adults with dementia-related psychosis who take antipsychotic medicines have a higher risk of death. Most deaths in studies were from heart problems (such as heart failure or sudden death) or infections (such as pneumonia). Lybalvi is not approved for dementia-related psychosis. Strokes and mini-strokes have also been reported in this group.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2021
Companies listing it with the FDA1
FDA label last updatedJan 31, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Olanzapine / Samidorphan L-Malate, written from its FDA label.

What Olanzapine / Samidorphan L-Malate is used for

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Olanzapine / samidorphan is used in adults for these conditions:

  • Schizophrenia (Lybalvi tablets)
  • Bipolar I disorder: acute treatment of manic or mixed episodes, alone or added to lithium or valproate (Lybalvi tablets)
  • Bipolar I disorder: maintenance treatment, used alone (Lybalvi tablets)

How Olanzapine / Samidorphan L-Malate works

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Olanzapine is an atypical antipsychotic. Its exact action is unclear, but it may work by blocking dopamine and serotonin type 2 receptors in the brain. Samidorphan blocks opioid receptors.

Olanzapine / Samidorphan L-Malate dosage

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Lybalvi is a tablet taken by mouth once a day, with or without food. Take it as a single tablet. Do not split it or combine strengths.

Your prescriber chooses the starting strength and adjusts it based on response and tolerability. Follow their directions and your pharmacy label.

Dosing details from the FDA-approved label

From the Olanzapine / Samidorphan L-Malate 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.

  • Schizophrenia
    • Initiate at 5 mg/10 mg or 10 mg/10 mg orally once daily
    • Recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily
    • Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component) depending upon clinical response and tolerability
    • Maximum: 20 mg/10 mg once daily
    • Administer once daily with or without food as a single tablet; do not divide tablets or combine strengths
  • Bipolar I disorder (manic or mixed episodes) - monotherapy
    • Initiate at 10 mg/10 mg or 15 mg/10 mg once daily
    • Recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily
    • Dosage adjustments at intervals of not less than 24 hours, in increments/decrements of 5 mg (based on the olanzapine component)
    • Maximum: 20 mg/10 mg once daily
    • Administer once daily with or without food
  • Bipolar I disorder - maintenance monotherapy
    • Administer at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily
  • Bipolar I disorder - adjunctive to lithium or valproate
    • Initiate at 10 mg/10 mg once daily
    • Recommended dosage is 10 mg/10 mg, 15 mg/10 mg or 20 mg/10 mg once daily
    • Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component), depending upon clinical response and tolerability
    • Maximum: 20 mg/10 mg once daily
  • Patients with higher risk of hypotensive reactions, at risk of slower olanzapine metabolism, or possibly more pharmacodynamically sensitive to olanzapine
    • Recommended starting dosage is 5 mg/10 mg once daily
    • If dose escalation is necessary, increase the dosage slowly in these patients
    • Specific population adjustment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Indication Recommended Starting Dose (olanzapine/samidorphan) Recommended Dose (olanzapine/samidorphan) Schizophrenia ( 2.2 ) 5 mg/10 mg or 10 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg Bipolar I disorder (manic or mixed episodes) ( 2.3 ) 10 mg/10 mg or 15 mg/10 mg 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg Bipolar I disorder adjunct to lithium or valproate ( 2.3 ) 10 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg See the full prescribing information for the recommended titration and maximum recommended dosage. ( 2.2 , 2.3 ) Administer LYBALVI once daily with or without food. Do not divide tablets or combine strengths. ( 2.4 ) Recommended starting dosage is 5 mg/10 mg once daily in patients who have a predisposition to hypotensive reactions, have potential for slower metabolism of olanzapine, or may be more pharmacodynamically sensitive to olanzapine. ( 2.5 ) 2.1 LYBALVI Initiation In Patients Using Opioids LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal. In patients who use opioids, delay initiation of LYBALVI for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids [see Warnings and Precautions ( 5.3 )]. 2.2 Recommended Dosage in Schizophrenia Initiate LYBALVI at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (contains 10 mg of olanzapine and 10 mg of samidorphan) orally once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (contains 15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (contains 20 mg of olanzapine and 10 mg of samidorphan) once daily. Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component of LYBALVI) depending upon clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once daily. 2.3 Recommended Dosage in Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy: Initiate LYBALVI at 10 mg/10 mg or 15 mg/10 mg once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily. The maximum recommended dosage is 20 mg/10 mg once daily. Dosage adjustments should occur at intervals of not less than 24 hours. When dosage adjustments are necessary, dose increments/decrements of 5 mg (based on the olanzapine component of LYBALVI) are recommended.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Olanzapine / Samidorphan L-Malate side effects

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The most common side effects include:

Common side effects

  • Weight gain
  • Sleepiness (somnolence)
  • Dry mouth
  • Headache
  • Increased appetite
  • Dizziness
  • Constipation

When to get medical help

  • Get emergency help for fever, stiff muscles, confusion, or a racing or irregular pulse. These can be signs of neuroleptic malignant syndrome, a rare but potentially fatal reaction.
  • Call your doctor right away for a rash with fever, swollen glands, or signs of organ problems. These can signal DRESS, a serious drug reaction.
  • Tell your doctor about uncontrolled movements of the face, tongue, or body. This could be tardive dyskinesia, which may become permanent.
  • Call your doctor for extreme thirst, frequent urination, increased hunger, or weakness. These can be signs of high blood sugar.
  • Report fainting or dizziness when standing, which can be a sign of low blood pressure.
  • Seek help for signs of stroke, especially in older adults with dementia.
  • Do not take opioids to try to overcome Lybalvi's blocking effect. This can cause a fatal opioid overdose.
  • Report seizures, or signs of infection such as fever, which may reflect a low white blood cell count.

Olanzapine / Samidorphan L-Malate warnings and precautions

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  • Dementia-related psychosis: Higher risk of death and stroke in older adults. Lybalvi is not approved for this use.
  • Opioids: It can trigger severe withdrawal and make overdose more dangerous if you try to overcome the blockade.
  • Metabolic changes: Blood sugar, cholesterol, and weight should be monitored.
  • Low blood pressure and falls: Risk is highest when starting or raising the dose.
  • Tardive dyskinesia: Involuntary movements that may be permanent.
  • Low white blood cell counts: Blood counts may be checked, especially if yours have been low before.
  • Other: Seizures, trouble swallowing, sleepiness, body temperature problems, anticholinergic effects, and raised prolactin.

Olanzapine / Samidorphan L-Malate interactions

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Several medicines and substances can change how Lybalvi works or add to its effects:

  • Opioids: contraindicated, because of withdrawal and overdose risk.
  • Strong CYP3A4 inducers: may make it less effective, so not recommended.
  • Strong CYP1A2 inhibitors: raise olanzapine levels, so a lower dose may be considered.
  • CYP1A2 inducers: lower olanzapine levels, so a higher dose may be considered.
  • Alcohol, diazepam, and other brain-acting drugs: may worsen low blood pressure on standing.
  • Anticholinergic drugs: raise the risk of severe bowel slowing.
  • Blood pressure medicines: effects may be enhanced.
  • Levodopa and dopamine agonists: Lybalvi may block their effects, so not recommended.

Interactions listed in the FDA-approved label

From the Olanzapine / Samidorphan L-Malate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inducers: Decreases AUC inf of olanzapine and samidorphan, which may reduce LYBALVI efficacy. Concomitant use is not recommended.
  • Strong CYP1A2 inhibitors: Increases olanzapine AUC and Cmax, which may increase the risk of LYBALVI adverse reactions. Consider reducing the dosage of the olanzapine component of LYBALVI.
  • CYP1A2 inducers: Decreases olanzapine exposure, which may reduce LYBALVI efficacy. Consider increasing the dosage of the olanzapine component of LYBALVI.
  • Diazepam, alcohol, and other CNS acting drugs: May potentiate the orthostatic hypotension observed with olanzapine. Use LYBALVI with caution in patients receiving diazepam or other CNS acting drugs, or using alcohol.
  • Anticholinergic drugs: Can increase the risk for severe gastrointestinal adverse reactions related to hypomotility. Use LYBALVI with caution in patients receiving medications having anticholinergic (antimuscarinic) effects.
  • Antihypertensive agents: LYBALVI may enhance the effects of certain antihypertensive agents. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.
  • Levodopa and dopamine agonists: LYBALVI may antagonize the effects of levodopa and dopamine agonists. Concomitant use is not recommended.
  • Opioids: LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal and increases the risk of precipitating acute opioid withdrawal in opioid-dependent patients; opioid treatment may be less effective or ineffective shortly after LYBALVI discontinuation. Allow at least a 7-day opioid-free interval after short-acting opioids and at least 14 days after long-acting opioids before starting. In emergencies requiring opioids, discontinue LYBALVI; in non-emergency situations, discontinue at least 5 days before opioid treatment.
  • Opioid urine drug screens (laboratory tests): LYBALVI may be cross-reactive with urinary immunoassay methods for detecting opioids, resulting in false positive results. Use an alternative analytical technique (e.g., chromatographic methods) to confirm positive opioid urine drug screen results.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A4 Inducers : Not recommended. ( 7.1 ) Strong CYP1A2 Inhibitors : Consider dosage reduction of olanzapine component of LYBALVI. ( 7.1 ) CYP1A2 Inducer : Consider dosage increase of the olanzapine component of LYBALVI. ( 7.1 ) CNS Acting Drugs : May potentiate orthostatic hypotension. ( 7.1 ) Anticholinergic Drugs: Can increase risk for severe gastrointestinal adverse reactions. ( 7.1 ) Antihypertensive Agents : Monitor blood pressure. ( 7.2 ) Levodopa and Dopamine Agonists : Not recommended. ( 7.2 ) 7.1 Effects of Other Drugs on LYBALVI Table 4 describes clinically significant drug interactions where the concomitant use of other drugs affects LYBALVI. Table 4: Effects of Other Drugs on LYBALVI Strong CYP3A4 Inducer Clinical Implication: Coadministration of LYBALVI with a strong CYP3A4 inducer decreases AUC inf of olanzapine and samidorphan [see Clinical Pharmacology ( 12.3 )], which may reduce LYBALVI efficacy. Prevention or Management: Concomitant use of LYBALVI with strong CYP3A4 inducers is not recommended. Strong CYP1A2 Inhibitor Clinical Implication: Concomitant use of LYBALVI with a strong CYP1A2 inhibitor increases olanzapine AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of LYBALVI adverse reactions. Prevention or Management: Consider reducing the dosage of the olanzapine component in LYBALVI when used concomitantly with strong CYP1A2 inhibitors. CYP1A2 Inducer Clinical Implication: Concomitant use of LYBALVI with CYP1A2 inducers decreases olanzapine exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce LYBALVI efficacy. Prevention or Management: Consider increasing the dosage of the olanzapine component in LYBALVI when used concomitantly with CYP1A2 inducers.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

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 Olanzapine / Samidorphan L-Malate

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  • Do not use it if you take opioids or are in opioid withdrawal.
  • Wait at least 7 days after short-acting opioids and 14 days after long-acting opioids before starting.
  • If you need opioids for surgery, your doctor will plan to stop Lybalvi at least 5 days beforehand.
  • Not approved for dementia-related psychosis.
  • Tell your doctor about diabetes, heart or circulation disease, seizures, or low white blood cell counts.
  • Pregnancy: late-pregnancy use may cause movement or withdrawal symptoms in newborns. A pregnancy registry exists.
  • Breastfeeding: both drugs pass into milk, and infants should be watched for sedation and feeding problems.
  • Not recommended in end-stage kidney disease.
  • Safety and effectiveness in children have not been established.

Olanzapine / Samidorphan L-Malate overdose

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Overdose experience is limited. One person who took 11 tablets was found unresponsive and recovered within 2 days with hospital care. Olanzapine overdose can cause agitation, slurred speech, fast heartbeat, abnormal movements, and drowsiness ranging up to coma. There is no specific antidote, so care is supportive. Call Poison Control at 1-800-222-1222.

What Olanzapine / Samidorphan L-Malate does in the body

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Olanzapine binds strongly to serotonin, dopamine, histamine, and adrenergic receptors, and more weakly to muscarinic receptors. Samidorphan blocks mu-opioid receptors. At doses up to 1.5 times and 3 times the maximum daily amounts of olanzapine and samidorphan, Lybalvi did not meaningfully lengthen the QTc interval, a heart rhythm measure.

How your body processes Olanzapine / Samidorphan L-Malate

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Both medicines reach steady levels with once-daily dosing, olanzapine within about 7 days. Food has no clinically relevant effect. Olanzapine has a long half-life of roughly 35 to 52 hours, while samidorphan's is about 7 to 11 hours. Both are mainly broken down by the liver and cleared through urine and feces. Olanzapine may be cleared more slowly in older adults.

How to store Olanzapine / Samidorphan L-Malate

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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 the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Olanzapine / Samidorphan L-Malate: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Olanzapine / Samidorphan L-Malate — the kind of thing our pharmacy team would talk through with you at the counter.

What is Lybalvi used for?

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It treats schizophrenia and bipolar I disorder in adults. For bipolar I, it can treat manic or mixed episodes, alone or with lithium or valproate, and it can be used alone for maintenance.

How do I take it?

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Take one tablet by mouth once a day, with or without food. Don't split tablets or combine strengths. Follow your prescriber's directions and the label.

What side effects should I expect?

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The most common are weight gain, sleepiness, dry mouth, and headache. Your care team will check your weight, blood sugar, and cholesterol. Call your doctor about fainting, uncontrolled movements, fever with stiff muscles, extreme thirst, or signs of infection.

Can I take pain medicine or other opioids with it?

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No. Lybalvi contains an opioid blocker and can cause sudden, severe withdrawal if you use opioids. Trying to override the block with large doses can cause a fatal overdose. Tell every doctor you see that you take it, especially before surgery.

Is it safe for older adults with dementia?

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No. Lybalvi is not approved for dementia-related psychosis, because older adults with it who take antipsychotics have a higher risk of death and stroke.

What if I'm pregnant or breastfeeding?

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Talk to your prescriber first. Using it late in pregnancy may cause movement or withdrawal symptoms in newborns. Both drugs pass into breast milk, so babies should be watched for sleepiness, irritability, and poor feeding.

Is Olanzapine / Samidorphan L-Malate available over the counter?

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No. Olanzapine / Samidorphan L-Malate is a prescription medicine: every Olanzapine / Samidorphan L-Malate product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Olanzapine / Samidorphan L-Malate first available?

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The earliest FDA record we hold for Olanzapine / Samidorphan L-Malate is from 2021: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Olanzapine / Samidorphan L-Malate was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Olanzapine / Samidorphan L-Malate on HelloPharmacist

Detailed data & references for Olanzapine / Samidorphan L-Malate Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Olanzapine / Samidorphan L-Malate forms and strengths (how it comes)

Olanzapine / Samidorphan L-Malate 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

By mouth
Brands Lybalvi
How this form is used
What it may be used for
  • Lybalvi is used in adults for schizophrenia.
  • Lybalvi is used in adults for bipolar I disorder, including manic or mixed episodes and maintenance treatment.
Important instructions
  • Lybalvi is taken by mouth once daily, with or without food.
  • Lybalvi should be taken as a single tablet.
  • Do not divide Lybalvi tablets or combine strengths.
Available strengths 4 strengths
16 FDA-listed product records ⓘ

Olanzapine / Samidorphan L-Malate on the U.S. market: products, makers and brands

How Olanzapine / Samidorphan L-Malate 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.

1 company lists 4 Olanzapine / Samidorphan L-Malate product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2021. Brand names on the directory include Lybalvi; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
4
FDA-listed product records ⓘ
2021
Earliest FDA record ⓘ

How widely Olanzapine / Samidorphan L-Malate is used (Medicaid data)

A general measure of how commonly Olanzapine / Samidorphan L-Malate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q2 2025 – Q1 2026, summed across every form and brand of the drug.

Think of this as a proxy for how widely Olanzapine / Samidorphan L-Malate 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.

130,976
Medicaid prescriptions filled (Q2 2025 – Q1 2026)
$209.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Olanzapine / Samidorphan L-Malate prescribed? Of the 1,601 medications we measure, Olanzapine / Samidorphan L-Malate ranks #470 by Medicaid prescriptions — more than 71% of them.

Where Olanzapine / Samidorphan L-Malate ranks among the drugs we measure · Q2 2025 – Q1 2026 · neighbors ±5

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 / Samidorphan L-Malate, 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 / Samidorphan L-Malate NDCs with Medicaid activity.

Compare Olanzapine / Samidorphan L-Malate products

A representative set of FDA-listed product records for Olanzapine / Samidorphan L-Malate — 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 Oral Alkermes, Inc. NDA View NDC →
OLANZAPINE 10 mg/1; SAMIDORPHAN L-MALATE 10 mg Oral Alkermes, Inc. NDA View NDC →
OLANZAPINE 15 mg/1; SAMIDORPHAN L-MALATE 10 mg Oral Alkermes, Inc. NDA View NDC →
OLANZAPINE 20 mg/1; SAMIDORPHAN L-MALATE 10 mg Oral Alkermes, Inc. NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Olanzapine / Samidorphan L-Malate NDCs →

Olanzapine / Samidorphan L-Malate 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.

The FDA’s enforcement reports list no Olanzapine / Samidorphan L-Malate recalls since July 2021.

✅No Olanzapine / Samidorphan L-Malate recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

💵 What Olanzapine / Samidorphan L-Malate costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 5; 10 mg/1; mg $50.17–$55.28 per tablet NDC details & price history
Tablet, Film Coated · Oral 10; 10 mg/1; mg $50.07–$55.13 per tablet NDC details & price history
Tablet, Film Coated · Oral 15; 10 mg/1; mg $50.00–$55.13 per tablet NDC details & price history
Tablet, Film Coated · Oral 20; 10 mg/1; mg $50.08–$55.05 per tablet NDC details & price history
Tablet, Film Coated · Oral OLANZAPINE 10 mg/1; SAMIDORPHAN L-MALATE 10 mg $50.07–$55.13 per tablet NDC details & price history
Tablet, Film Coated · Oral OLANZAPINE 15 mg/1; SAMIDORPHAN L-MALATE 10 mg $50.00–$55.13 per tablet NDC details & price history
Tablet, Film Coated · Oral OLANZAPINE 5 mg/1; SAMIDORPHAN L-MALATE 10 mg $50.17–$55.28 per tablet NDC details & price history
Tablet, Film Coated · Oral OLANZAPINE 20 mg/1; SAMIDORPHAN L-MALATE 10 mg $50.08–$55.05 per tablet NDC details & price history
Tablet, Film Coated OLANZAPINE 5 mg/1; SAMIDORPHAN L-MALATE 10 mg $50.17–$55.28 per tablet NDC details & price history
Tablet, Film Coated OLANZAPINE 15 mg/1; SAMIDORPHAN L-MALATE 10 mg $50.00–$55.13 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Olanzapine / Samidorphan L-Malate brand names

Olanzapine / Samidorphan L-Malate is sold under one brand name in the FDA directory — Lybalvi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lybalvi

Who makes Olanzapine / Samidorphan L-Malate: manufacturers and labelers

One company lists Olanzapine / Samidorphan L-Malate products with the FDA. By number of product records, the largest are Alkermes, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Alkermes, Inc. 4

Sources for this Olanzapine / Samidorphan L-Malate 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 31, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Olanzapine / Samidorphan L-Malate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Olanzapine / Samidorphan L-Malate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Alkermes, Inc.
Linked label effective
Jan 31, 2026
Composite sections available
24
Linked SPL Set ID
32ffddd1-4e2b-45d9-9b36-bb730167ec80
Linked SPL Document ID
44ae69cc-b9a6-4658-90fa-1dbef1e97eb4
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 20
65757-0651-01 LYBALVI olanzapine and samidorphan L-malate 5 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0651-40 LYBALVI olanzapine and samidorphan L-malate 5 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0651-41 LYBALVI olanzapine and samidorphan L-malate 5 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0651-42 LYBALVI olanzapine and samidorphan L-malate 5 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0651-44 LYBALVI olanzapine and samidorphan L-malate 5 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0652-02 olanzapine and samidorphan l-malate 10 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0652-40 olanzapine and samidorphan l-malate 10 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0652-41 olanzapine and samidorphan l-malate 10 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0652-42 olanzapine and samidorphan l-malate 10 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0652-44 olanzapine and samidorphan l-malate 10 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0653-03 olanzapine and samidorphan l-malate 15 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0653-40 olanzapine and samidorphan l-malate 15 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0653-41 olanzapine and samidorphan l-malate 15 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0653-42 olanzapine and samidorphan l-malate 15 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0653-44 olanzapine and samidorphan l-malate 15 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0654-04 olanzapine and samidorphan l-malate 20 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0654-40 olanzapine and samidorphan l-malate 20 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0654-41 olanzapine and samidorphan l-malate 20 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0654-42 olanzapine and samidorphan l-malate 20 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes, 65757-0654-44 olanzapine and samidorphan l-malate 20 mg/1; 10 mg/1 TABLET, FILM COATED Alkermes,

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HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Alkermes, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →