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Lybalvi

Pronunciation: lee-bawl-vee
Generic name: olanzapine and samidorphan
Dosage form: oral tablet (5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg)
Drug class: Psychotherapeutic combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 19, 2025.

What is Lybalvi?

Lybalvi is a combination antipsychotic/opioid antagonist prescription medicine that is used to treat adults with manic or mixed episodes associated with bipolar I disorder (either alone or in combination with valproate or lithium) or adults with schizophrenia. It is an oral tablet that is taken once a day.

Lybalvi combines two active ingredients:

Lybalvi is not a controlled substance.

Lybalvi (olanzapine and samidorphan) gained FDA approval on May 28, 2021. There is no generic. 

How does Lybalvi work?

Lybalvi combines 2 ingredients, olanzapine and samidorphan, each with different mechanisms of action.

Lybalvi side effects

The most common side effects of Lybalvi when used to treat people with schizophrenia include:

The most common side effects of Lybalvi when used alone to treat people with mixed or manic episodes that happen with bipolar I disorder include:

Additional common side effects of Lybalvi reported in clinical trials that may happen when it is used in combination with lithium or valproate for bipolar I disorder include:

Serious side effects and warnings

Lybalvi may cause serious side effects and carries a Boxed Warning for an increased risk of death in elderly people with dementia-related psychosis.

Lybalvi increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Lybalvi is not approved for the treatment of people with dementia-related psychosis.

Lybalvi may cause other serious side effects, including the following.

Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Lybalvi is not approved for the treatment of people with dementia-related psychosis.

Opioid withdrawal. Do not take Lybalvi for at least 7 days after you stop taking short-acting opioids and for at least 14 days after you stop taking long-acting opioids. One of the medicines in Lybalvi (samidorphan) can cause opioid withdrawal that may be severe and cause hospitalization in people who are physically dependent on opioids. Talk to your healthcare provider if you have questions about the type of opioid you take.

Risk of life-threatening opioid overdose. You should not start taking opioids for at least 5 days after you stop treatment with Lybalvi. One of the medicines in Lybalvi (samidorphan) can increase your chance of having an opioid overdose that can cause death if you take opioids during treatment or within 5 days after stopping treatment with Lybalvi. You can accidentally overdose in 2 ways:

Tell your healthcare provider if you are taking Lybalvi before a medical procedure or surgery.

Neuroleptic malignant syndrome (NMS), is a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): One of the medicines in Lybalvi (olanzapine) can cause DRESS which can cause death. Tell your healthcare provider right away if you develop any of the following symptoms of DRESS, including:

Problems with your metabolism such as:

Uncontrolled body movements (tardive dyskinesia). Lybalvi may cause movements you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Lybalvi. Tardive dyskinesia may also start after you stop taking Lybalvi.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls. Lybalvi may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and slow your thinking and motor skills, leading to falls that can cause fractures or other injuries.

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Lybalvi.

Difficulty swallowing that can cause food or liquid to get into your lungs.

Seizures (convulsions).

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking Lybalvi?”

Increased prolactin levels in your blood. Your healthcare provider may do blood tests to check your prolactin levels during treatment with Lybalvi.

It is not known if Lybalvi is safe or effective in children.

These are not all the possible side effects of Lybalvi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

Lybalvi false positives

Tell your healthcare provider if you take a urine drug screening test because Lybalvi may cause false positive results in opioid urine screening tests.

If you do experience a positive result for an opioid urine drug screening test and you also take Lybalvi, ask the testing provider to use a different analytical technique, such as chromatography to confirm or negate positive opioid urine drug screen results.

Before taking

Do not take Lybalvi if you are taking opioids or are experiencing acute opioid withdrawal.

Before taking Lybalvi, tell your healthcare provider about all of your medical conditions, including if you:

Pregnancy

Talk to your healthcare provider about the risks to you and your unborn or newborn baby if you take Lybalvi during pregnancy.

Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Lybalvi.

If you become pregnant during treatment with Lybalvi, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/

Breastfeeding

Lybalvi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Lybalvi.

How should I take Lybalvi?

Take Lybalvi exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking Lybalvi without first talking to your healthcare provider.

Lybalvi doses

Recommended Lybalvi dosage for schizophrenia

Starting dose: Lybalvi 5-10 mg or 10-10 mg

Maintenance dosage: Lybalvi 10-10 mg, 15-10 mg, or 20-10 mg

Recommended Lybalvi dosage for Bipolar 1 disorder (manic or mixed episodes)

Starting dose: Lybalvi 10-10 mg or 15-10 mg

Maintenance dosage: Lybalvi 5-10 mg, 10-10 mg, or 15-10 mg, or 20-10 mg

Recommended Lybalvi dosage for Bipolar 1 disorder (manic or mixed episodes) with lithium or valproate

Starting dose: Lybalvi 10-10 mg

Maintenance dosage: Lybalvi 10-10 mg, or 15-10 mg, or 20-10 mg

What happens if I overdose?

If you take too much Lybalvi, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking Lybalvi?

Lybalvi may make you sleepy. Do not drive a car, operate machinery, or do other dangerous activities until you know how Lybalvi affects you.

Avoid drinking alcohol during treatment with Lybalvi.

Avoid getting over-heated or dehydrated.

What other drugs will affect Lybalvi?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Lybalvi and other medicines may affect each other causing possible serious side effects. Lybalvi may affect the way other medicines work, and other medicines may affect how Lybalvi works.

Especially tell your healthcare provider if you:

Your healthcare provider can tell you if it is safe to take Lybalvi with your other medicines. Do not start or stop any medicines while taking Lybalvi without first talking to your healthcare provider. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine

Does Lybalvi interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Lybalvi storage

Store Lybalvi at room temperature between 68°F to 77°F (20°C to 25°C).

Keep tightly closed, in a dry place, and away from moisture.

Keep out of the reach of children.

Lybalvi ingredients

Lybalvi active ingredients: olanzapine and samidorphan

Lybalvi inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

Film coating ingredients include hypromellose, titanium dioxide, triacetin and iron oxide yellow (Lybalvi 5 mg/10 mg); iron oxide yellow and iron oxide red (Lybalvi 10 mg/10 mg); FD&C Blue No. 2/indigo carmine aluminum lake (Lybalvi 15 mg/10 mg); iron oxide red (Lybalvi 20 mg/10 mg).

Who makes Lybalvi?

Lyblavi is made by Alkermes, Inc. who have headquarters in Dublin, Ireland, a research center in Waltham, Massachusetts, and a manufacturing facility in Wilmington, Ohio. Other notable drugs made by Alkermes, Inc. include:

Popular FAQ

Will Lybalvi trigger a false positive for opioids?

Yes, Lybalvi (olanzapine and samidorphan) can cause a false positive urine test result for opioids on certain tests used for detecting opioids. The manufacturer suggests using an alternative test for opioids if you are taking Lybavli, such as chromatographic methods. Continue reading

Does Lybalvi cause weight gain?

Weight gain is a possible side effect of Lybalvi (olanzapine and samidorphan). During a 4-week clinical trial, 19% of people reported weight gain compared to 3% of people taking a placebo (no active medication). In a 24-week study, 25% of people taking Lybalvi reported gaining weight. Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.