Lybalvi (olanzapine/samidorphan) is a prescription drug that’s used to treat schizophrenia and bipolar I disorder. Lybalvi comes as an oral tablet.

Lybalvi is used in adults to treat:

To learn more about these conditions, see the “What is Lybalvi used for?” section of this article.

Lybalvi medication basics

Lybalvi comes as a tablet that you swallow. It’s not available in a generic form.

Lybalvi contains two active ingredients: olanzapine and samidorphan. (An active ingredient is what makes a drug work.)

Is Lybalvi an opioid?

No, Lybalvi is not an opioid. Lybalvi’s active ingredient, olanzapine, belongs to a group of drugs called antipsychotics, and its other active ingredient, samidorphan, is an opioid antagonist.

Opioid antagonists block the effects of opioid drugs. They do this by binding to opioid receptors (attachment sites) on cells. But they don’t fully activate the receptors, and they don’t cause the same effects as opioids.

Doctors won’t prescribe Lybalvi if you’ve recently taken opioids or if you’re having opioid withdrawal symptoms. Taking Lybalvi in this situation could lead to opioid withdrawal or a life threatening opioid overdose. (You can refer to this Lybalvi interactions article for details.)

Read on to learn about Lybalvi’s side effects, dosage, and more.

Like most drugs, Lybalvi may cause mild to serious side effects. The lists below describe some of the more common side effects the drug may cause, but don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Lybalvi. They can also suggest ways to help reduce them.

Mild side effects

Below is a list of some of the mild side effects Lybalvi can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read the drug’s prescribing information.

Mild side effects of Lybalvi that have been reported include:

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Lybalvi can occur, but they aren’t common. If you have serious side effects from this drug, call your doctor right away. But if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects of Lybalvi that have been reported include:

* For more information, see the “What should be considered before taking Lybalvi?” section of this article.
† To learn more about this side effect, see the “Allergic reaction” standout.

Allergic reaction

Some people may have an allergic reaction to Lybalvi. While allergic reaction wasn’t reported in studies of Lybalvi, it can still happen.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

DRESS syndrome (drug reaction with eosinophilia and systemic symptoms) is also possible. This is a severe allergic reaction involving fever, rash, and other symptoms that can affect your entire body.

Call your doctor right away if you have an allergic reaction to Lybalvi. But if you think you’re having a medical emergency, call 911 or your local emergency number.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

Costs of prescription drugs can vary depending on many factors, including what your insurance plan covers and which pharmacy you use.

You can visit Optum Perks to get up-to-date price estimates of what you’d pay for Lybalvi when using coupons from the site. See the coupon options below. (Note: Optum Perks coupons cannot be used with any insurance copays or benefits.)

The Lybalvi copay savings program may also be an option to help you save on the cost of Lybalvi.

You can refer to this in-depth Lybalvi cost article for details about the drug’s cost.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also check out this article to learn more about saving money on prescriptions.

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Retail price refers to the manufacturer’s published list price and is up to date as of 3/2023. Retail and discounted prices are U.S.-only and can vary based on region and pharmacy. We cannot guarantee that the discounted price listed here will exactly match the price at your pharmacy. Please contact your pharmacy for the exact price.

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Find answers to some commonly asked questions about Lybalvi.

What is Lybalvi’s mechanism of action (how it works)?

Lybalvi is used to treat the following conditions in adults:

The exact way Lybalvi works to treat these conditions isn’t known for sure.

It’s thought that Lybalvi helps balance the levels of dopamine and serotonin in your body. Among other functions, these chemicals help your body regulate mood and experience pleasure, and may play a role in schizophrenia and bipolar I disorder. By balancing levels of dopamine and serotonin, Lybalvi can help ease symptoms of these conditions.

If you have more questions about how Lybalvi works, talk with your doctor or pharmacist.

Is Lybalvi a controlled substance?

No, Lybalvi is not a controlled substance, which is a medication with a high risk of misuse. (With misuse, a person uses a drug in a way other than how a healthcare professional prescribes it.) Because of this risk, controlled substances are regulated by the government, and doctors must follow special rules when prescribing these drugs.

But Lybalvi is not known to cause misuse, so the drug is not a controlled substance.

How does Lybalvi compare with olanzapine?

Lybalvi contains two active ingredients: olanzapine and samidorphan. (An active ingredient is what makes a drug work.) Olanzapine is also available as the brand-name drug Zyprexa.

Since Lybalvi contains olanzapine, these drugs are expected to be similar. In studies, Lybalvi was shown to be just as effective as olanzapine for the treatment of schizophrenia and bipolar I disorder in certain adults.

But in the drug’s studies for schizophrenia, people taking Lybalvi had significantly less weight gain than people taking olanzapine alone. It’s thought that the samidorphan ingredient of Lybalvi can help to prevent weight gain, a common side effect of olanzapine. And even though Lybalvi may cause less weight gain than olanzapine alone, weight gain is still a commonly reported side effect of Lybalvi.

If you have other questions about how Lybalvi compares with olanzapine, talk with your doctor or pharmacist.

Your doctor will recommend the dosage of Lybalvi that’s right for you. Below are commonly used dosages, but always take the dosage your doctor prescribes.

Form and strengths

Lybalvi comes as a tablet that you swallow. It contains two active ingredients: olanzapine and samidorphan. (An active ingredient is what makes a drug work.)

Lybalvi comes in four strengths:

  • 5 milligrams (mg) olanzapine/10 mg samidorphan
  • 10 mg olanzapine/10 mg samidorphan
  • 15 mg olanzapine/10 mg samidorphan
  • 20 mg olanzapine/10 mg samidorphan

Recommended dosage

Your doctor will usually start you on a low dose of Lybalvi. This is sometimes called a “starting dose.” Then they’ll adjust it over time until you reach a dose that treats your condition without causing bothersome side effects.

You’ll likely take Lybalvi once per day. Your exact dosage will be based on several factors, including:

  • the condition you’re taking the drug to treat
  • how effective the drug is at managing your condition
  • how well your body breaks down the drug
  • other medications you’re taking

To learn more about Lybalvi’s dosage, talk with your doctor. You can also find more dosage details in this article.

Questions about Lybalvi’s dosing

Below are some common questions about Lybalvi’s dosing.

  • What if I miss a dose of Lybalvi? If you miss a dose of Lybalvi, talk with your doctor. They can advise you on whether to take the missed dose or skip it.
  • Will I need to take Lybalvi long term? It’s possible. If Lybalvi is working well for your condition without causing bothersome side effects, you’ll likely take the drug long term.
  • How long does Lybalvi take to work? Lybalvi starts working as soon as you take it. But it may take several weeks for the symptoms of your condition to ease. If you have questions about what to expect while taking Lybalvi, talk with your doctor.

Lybalvi is used to treat the following conditions in adults:

Keep reading to learn more about these conditions and how Lybalvi is used to treat them.

Schizophrenia

Lybalvi is used to treat schizophrenia, a mental health condition that affects how a person thinks, feels, and behaves.

Symptoms of schizophrenia may include:

Manic and mixed episodes related to bipolar I disorder

Lybalvi is used to treat manic and mixed episodes related to bipolar I disorder.

Bipolar I disorder is a mood disorder that usually includes the following:

  • manic episodes, which cause moments of feeling extremely excited and energetic
  • depressed episodes, which cause moments of feeling hopeless or losing interest in activities you once enjoyed
  • mixed episodes, which cause moments of mania and depression that occur at the same time

Lybalvi can be used as a short-term treatment for manic and mixed episodes.

Maintenance treatment of bipolar I disorder

For long-term treatment of bipolar I disorder, your doctor may prescribe Lybalvi together with lithium (Lithobid) or valproate.

If your doctor has prescribed Lybalvi as a short-term treatment for manic or mixed episodes, they may have you continue Lybalvi treatment in combination with lithium or valproate after the symptoms have eased. Or they may switch you to a different treatment for long-term use.

Your doctor will explain how you should take Lybalvi. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions.

Taking Lybalvi

Lybalvi comes as a tablet that you swallow.

Accessible medication containers and labels

Certain pharmacies may provide medication labels that:

  • have large print
  • use braille
  • contain a code you can scan with a smartphone to change the text to audio

Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn’t.

Also, if you’re having trouble opening your medication bottles, let your pharmacist know. They may be able to put Lybalvi in an easy-open container. They may also be able to recommend tools to help make it simpler to open the drug’s container.

Taking Lybalvi with other drugs

If you take Lybalvi to treat bipolar I disorder, your doctor may prescribe it along with certain other drugs.

Specifically, Lybalvi may be used together with lithium (Lithobid) or valproate for long-term treatment of bipolar I disorder.

Your doctor will tell you whether Lybalvi should be used by itself or together with other treatments.

Questions about taking Lybalvi

Below are some common questions about taking Lybalvi.

  • Can Lybalvi be chewed, crushed, or split? No, you should not chew, crush, or split Lybalvi tablets. You’ll swallow them whole. If you have trouble swallowing Lybalvi, check out this article or talk with your doctor or pharmacist.
  • Should I take Lybalvi with food? You can take Lybalvi with or without food.
  • Is there a best time of day to take Lybalvi? No, there’s not a best time of day to take Lybalvi. You can take the drug any time of day.
Questions for your doctor

You may have questions about Lybalvi and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

  • Before your appointment, write down questions such as:
    • How will Lybalvi affect my body, mood, or lifestyle?
  • Bring someone with you to your appointment if doing so will help you feel more comfortable.
  • If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.

There are certain things you should discuss with your doctor before starting Lybalvi. It’s important to tell them about your overall health, other medical conditions you may have, and all the medications you take. These factors and others are described in more detail below.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before taking Lybalvi, be sure to tell your doctor about all medications you take, including prescription and over-the-counter kinds. Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Lybalvi.

For information about drug-condition interactions, see the “Other warnings” section below.

Interactions with drugs or supplements

Lybalvi can interact with several kinds of drugs. These include:

This list does not contain all kinds of drugs that may interact with Lybalvi. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with use of Lybalvi.

Other interactions

Lybalvi can cause false-positive results on urine drug tests that check for opioids. (A false positive means the test shows that there are opioids in your body, when really there are not.)

If you need a urine drug test, be sure that the tester knows that you’re taking Lybalvi. There are other drug screening tests available that don’t interact with Lybalvi.

Boxed warning

Lybalvi has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.

Antipsychotic drugs* may increase the risk of death in certain older adults (ages 65 years and above). Specifically, this risk is higher in older adults with psychosis related to dementia. With psychosis, you have trouble understanding what’s real and what isn’t. And with dementia, you have problems with thinking, memory, and communication.

In some cases, antipsychotic drugs can also increase the risk of stroke when used in older adults with psychosis related to dementia. Possible symptoms of stroke include:

  • headache
  • trouble speaking or walking
  • weakness in your face, arm, or leg on one side of your body

Stroke is a medical emergency. If you have symptoms of this condition while you’re taking Lybalvi, call 911 or your local emergency number right away.

Due to the risks of death and stroke, doctors usually will not prescribe Lybalvi for older adults with psychosis related to dementia.

* Lybalvi contains the antipsychotic drug olanzapine as one of its active ingredients. An active ingredient is what makes a drug work.

Other warnings

Lybalvi may not be right for you if you have certain medical conditions. (This is known as a drug-condition interaction.) Other factors may also affect whether Lybalvi is a good treatment option for you.

Talk with your doctor about your health history before starting this drug. Be sure to tell them if any of the following factors apply to you:

Lybalvi and alcohol

It’s recommended that you limit or avoid alcohol while taking Lybalvi. This is because alcohol can worsen certain side effects of this drug. Examples include:

If you have questions about consuming alcohol during Lybalvi treatment, talk with your doctor. They can help determine what amount, if any, is safe for you to drink while taking the drug.

Pregnancy and breastfeeding

Below we provide information about Lybalvi and pregnancy and breastfeeding.

Lybalvi and pregnancy

It isn’t known whether Lybalvi is safe to take during pregnancy. The drug hasn’t specifically been studied in people who are pregnant. But antipsychotic drugs* can increase the risk of side effects in infants if they’re taken in the last 3 months of the pregnancy. Examples of possible side effects in infants can include:

  • trouble eating
  • sleepiness
  • trouble breathing
  • agitation (acting restless or bothered)
  • increased or decreased muscle tone
  • tremor

If you take Lybalvi during pregnancy, consider enrolling in the National Pregnancy Registry for Atypical Antipsychotics. Pregnancy registries collect information about the safety of drugs when used during pregnancy. For more information, talk with your doctor. You can also call 866-961-2388 or visit the registry’s website.

* Lybalvi contains the antipsychotic drug olanzapine as one of its active ingredients. An active ingredient is what makes a drug work.

Lybalvi and breastfeeding

Lybalvi may pass into breast milk during breastfeeding. If the drug is taken while breastfeeding, Lybalvi may cause the following side effects in a child who is breastfed:

  • tremor
  • irregular muscle movements
  • sleepiness
  • irritability
  • trouble eating

If you’re breastfeeding or planning to do so, talk with your doctor before taking Lybalvi. They can advise you on whether it’s safe to breastfeed while taking the drug. They can also recommend other ways to feed your child.

Withdrawal and dependence were not reported as side effects in studies of Lybalvi. Withdrawal symptoms are side effects that can happen when you stop taking a drug your body has become dependent on. With dependence, your body gets used to a drug and needs it for you to feel comfortable.

But withdrawal symptoms have been reported since Lybalvi became available for use. Examples of withdrawal symptoms that may happen include nausea, vomiting, and sweating.

Due to the risk of withdrawal symptoms, it’s important that you do not stop taking Lybalvi without talking with your doctor. They’ll tell you whether it’s safe to stop taking the drug.

If your doctor tells you it’s safe to stop Lybalvi, they may slowly lower your dosage over time to help reduce your risk of withdrawal symptoms. They can tell you whether a treatment other than Lybalvi is recommended for your condition.

Do not take more Lybalvi than your doctor prescribes, as this can lead to serious side effects.

Symptoms of overdose

Symptoms caused by an overdose can include:

What to do in case you take too much Lybalvi

Call your doctor if you think you’ve taken too much Lybalvi. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.

If you have questions about taking Lybalvi, talk with your doctor or pharmacist. Questions you may want to ask include:

  • Will any of the medications I take interact with Lybalvi?
  • Will Lybalvi cure my condition?
  • Do I personally have an increased risk of certain side effects with Lybalvi?

To learn more about Lybalvi, see these articles:

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.