What is Lybalvi? Uses, warnings & side effects

Medically reviewed by Peter Lourgos, MD, JD
Psychiatrist
Updated Dec 18, 2025  •  Published Nov 6, 2021
Datos Verificados

Lybalvi is approved for the treatment of manic or mixed episodes in adults with bipolar 1 disorder or schizophrenia. Lybalvi contains olanzapine and samidorphan, and it may be used alone or in combination with valproate or lithium. It should not be used in patients using opioids or undergoing opioid withdrawal.

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Lybalvi overview

BRAND NAMES:

  • Lybalvi

Generic Names:

  • Olanzapine-samidorphan

Uses:

Forms:

  • Tablet

How it’s taken:

  • By mouth

What is Lybalvi used for?

Lybalvia is used to treat adults with bipolar 1 disorder or schizophrenia.

Key takeaways

  • A combination pill containing olanzapine and samidorphan.

  • Associated with less weight gain than taking olanzapine alone.

  • A good option for individuals responding favorably to olanzapine but experiencing weight gain.

  • It is expensive, and no generic version is available.

What form(s) does Lybalvi come in?

  • Tablet

    • 5 mg olanzapine/10 mg samidorphan

    • 10 mg/10 mg

    • 15 mg/10 mg

    • 20 mg/10 mg

What are common Lybalvi dosages?

  • For schizophrenia: 

    • Recommended starting dose: 5 mg/10 mg or 10 mg/10 mg once per day

    • Recommended maintenance dose: 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once per day

  • For bipolar 1 disorder (monotherapy):

    • Recommended starting dose: 10 mg/10 mg or 15 mg/10 mg once per day

    • Recommended maintenance dose: 5 mg/ 10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once per day

  • For bipolar 1 disorder (in combination with valproate or lithium):

    • Recommended starting dose: 10 mg/10 mg once per day

    • Recommended maintenance dose: 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once per day

Lybalvi images - What does Lybalvi look like?

  • Lybalvi
    10-10mg tablet

  • Lybalvi
    15-10mg tablet

  • Lybalvi
    20-10mg tablet

  • Lybalvi
    5-10mg tablet

How to take Lybalvi

  • Lybalvi may be used alone or in combination with valproate or lithium.

  • Lybalvi dosage may be adjusted by 5 mg on a weekly basis.

  • Do not exceed 20 mg/10 mg once per day.

  • You can take Lybalvi with or without food.

  • Do not divide the tablet.

What to do if you miss a dose of Lybalvi

If you miss a dose, take it as soon as you remember. However, if it is closer in time to the next dose, skip it and just take your regular dose at your usual time. Do not take double the dose at one time.

Lybalvi contraindications - Who shouldn't take Lybalvi?

Do not take Lybalvi if you use opioids or are undergoing acute opioid withdrawal.

Lybalvi warnings

Lybalvi may cause:

  • An increased risk of cerebrovascular adverse reactions (such as a stroke) in older adults with dementia-related psychosis

  • Opioid withdrawal in people who are dependent on opioids

  • Increased risk of opioid overdose in people who attempt to overcome the blocked effects that Lybalvi has on opioids by taking more or higher doses of opioids

  • Increased risk of resuming opioids in people with prior opioid use.

  • Increased risk of neuroleptic malignant syndrome (high fever, stiff muscles, confusion, sweating, changes to breathing, pulse, heart rate, or blood pressure)

  • A drug reaction with eosinophilia and systemic symptoms (rash, high fever, inflammation of organs)

  • Metabolic changes like increased blood sugars, increased fats in the blood, and weight gain

  • Tardive dyskinesia (uncontrollable movements in the face and body)

  • Lightheadedness and fainting

  • Falls

  • Significant drop in white blood cell count

  • Difficulty swallowing

  • Seizures

  • Cognitive and motor impairment

  • Severe heat or cold intolerance

  • Anticholinergic effects, like constipation, dry mouth, and increased heart rate

  • Abnormally high levels of the hormone prolactin (responsible for stimulating breast milk production during and after pregnancy)

  • False-positive results for opioid drug tests

Lybalvi interactions & what to avoid when taking Lybalvi

  • Strong CYP3A4 inducers (phenytoin, carbamazepine, rifampin)

  • Strong CYPIA2 inhibitors (grapefruit juice, allopurinol, ciprofloxacin, fluvoxamine, oral contraceptives, propranolol)

  • CYPIA2 inducers (tobacco smoke, cruciferous vegetables, phenytoin, phenobarbital, rifampin, omeprazole)

  • CNS-acting drugs (ADHD medications, anti-anxiety medications, migraine medications, Anti-Parkinson's medications)

  • Anticholinergic drugs (asthma/ COPD medications, Benadryl, medications to treat nausea/ dizziness)

  • Medications used to treat high blood pressure

Lybalvi side effects - How does Lybalvi make you feel?

Lybalvi can cause serious side effects. Please contact your doctor immediately or go to your local ER if you develop any of the following:

  • Stroke in older adults with dementia-related psychosis

  • Numbness or tingling in arms and legs

  • Opioid withdrawal

  • Opioid overdose

  • Neuroleptic malignant syndrome (high fever, stiff muscles, confusion, sweating, changes to breathing, pulse, heart rate, or blood pressure)

  • Drug reaction with eosinophilia and systemic symptoms (rash, high fever, inflammation of organs)

  • High blood sugar and diabetes

  • Lower blood pressure, fainting, and falls

  • Low white blood cell count

  • Difficulty swallowing

  • Problems speaking

  • Confusion/memory problems

  • Seizures

  • Severe heat or cold intolerance

  • Milk secretion from the breast when not pregnant or breastfeeding

  • Dark urine

Common side effects in people with schizophrenia:

  • Weight gain

  • Increased fat levels in your blood

  • Dry mouth

  • Sleepiness

  • Headache

  • Shakiness

  • Dizziness

Common side effects in people with bipolar 1 disorder:

  • Weakness

  • Constipation

  • Sleepiness

  • Shakiness

  • Dry mouth

  • Weight gain

  • Increased fat levels in your blood

  • Dizziness

Common side effects in people using Lybalvi with lithium or valproate:

  • Dry mouth

  • Sleepiness

  • Back pain

  • Weight gain

  • Increased fat levels in your blood

  • Dizziness

  • Shakiness

  • Constipation

  • Mouth watering

Sources:

Medically reviewed by Peter Lourgos, MD, JD
Psychiatrist

Peter Lourgos, MD, JD, was born and raised near Chicago. During his college years, he developed an interest in the intersection of law and medicine and subsequently enrolled in a dual degree medicine/law program at Southern Illinois University. He completed residency training in general and forensic psychiatry and is board-certified in both areas.

After completing his training, he worked as a criminal forensic psychiatrist for the Circuit Court of Cook County in Chicago, where he evaluated individuals charged with various crimes and reported his findings to the court. During this time, he served as a Clinical Associate Professor of Psychiatry, where he trained both medical students and resident physicians.

He has also served as a medical consultant to several large insurance providers.

Dr. Lourgos maintains an active clinical practice and sees patients for a variety of mental health concerns, including mood disorders, anxiety disorders, PTSD, and trauma. He has a passion for teaching others about mental health issues as it contributes to positive overall health and decreases the stigma often associated with mental health diagnoses.

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