Lybalvi (Olanzapine and Samidorphan) for Schizophrenia

Lybalvi (olanzapine and samidorphan) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat schizophrenia in adults.

How Lybalvi Works and How It’s Taken

Lybalvi is a type of antipsychotic medicine. It contains olanzapine and samidorphan. It works in the brain by affecting chemicals like dopamine and serotonin.

These changes may help rebalance brain activity. The exact way Lybalvi works is not fully known.

Doctors prescribe Lybalvi to treat schizophrenia in adults. By affecting these brain pathways, the medication may help reduce symptoms linked to thinking, mood, and perception.

Lybalvi is taken by mouth as a tablet once a day. It can be taken with or without food.

Typical Dosing for Schizophrenia

The recommended starting dose of Lybalvi for schizophrenia is 5 milligrams/10 milligrams or 10 milligrams/10 milligrams taken by mouth once daily.

For people who respond to treatment, the recommended maintenance dose is 10 milligrams/10 milligrams, 15 milligrams/10 milligrams, or 20 milligrams/10 milligrams once daily.

Doctors may adjust the dose at weekly intervals in 5-milligram steps based on response and tolerability, up to a maximum of 20 milligrams/10 milligrams once daily.

In people at higher risk of low blood pressure, slower metabolism, or increased sensitivity to the medicine, doctors may start with 5 milligrams/10 milligrams once daily and increase the dose more gradually if needed.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Lybalvi Side Effects

In clinical studies of Lybalvi for schizophrenia in adults, the most common side effects occurred in about 6 percent to 19 percent of people. These include:

Weight gain
Somnolence (sleepiness)
Dry mouth
Headache

Serious Side Effects and Warnings

Lybalvi can cause serious side effects that require immediate medical attention. These include:

Increased risk of death in older adults with dementia-related psychosis — Lybalvi is not approved for dementia-related psychosis.
Cerebrovascular adverse reactions — Stroke or transient ischemic attack (TIA, sometimes called a mini-stroke) can occur in older adults with dementia-related psychosis.
Severe opioid withdrawal — Sudden withdrawal symptoms can occur if you are physically dependent on opioids.
Life-threatening opioid overdose risk — This can occur if someone tries to override Lybalvi’s opioid-blocking effect with high doses of opioids.
Neuroleptic malignant syndrome (NMS) — This is a rare, life-threatening reaction that can cause very high fever, stiff muscles, confusion, and unstable blood pressure or heart rate.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) — This is a serious drug reaction that can cause rash, fever, swollen lymph nodes, and organ problems.
Metabolic changes — These can include high blood sugar or diabetes, unhealthy cholesterol or triglyceride levels, and weight gain.
Tardive dyskinesia — Uncontrolled, repeated movements may not go away.
Orthostatic hypotension and syncope — A sudden drop in blood pressure when standing and fainting can occur.
Falls — These may happen because of sleepiness, low blood pressure, or balance problems.
Low white blood cell counts, including neutropenia and agranulocytosis — These can raise infection risk.
Dysphagia — Trouble swallowing can raise the risk of choking or breathing food or liquid into the lungs.
Seizures — Seizures can occur.
Cognitive and motor impairment — Problems with thinking or motor skills can affect driving or using machinery.
Body temperature dysregulation — Overheating or trouble cooling down can occur.
Anticholinergic effects — These can include severe constipation or trouble urinating.
Hyperprolactinemia — High prolactin levels can cause breast milk production, missed periods, breast enlargement, or sexual side effects.

Get medical help right away if you think you are having a serious reaction.

How To Save on Lybalvi

Alkermes, the manufacturer of Lybalvi, offers the Lybalvi Co-Pay Savings Program. Eligible people with commercial insurance may pay as little as $0 per 30-day supply for the first three prescriptions, and as little as $20 per 30-day supply starting with the fourth prescription.

The Lybalvi Co-Pay Savings Program also includes the Lybalvi Care Support Program, administered by ASPN Pharmacies. This program can help check and explain your insurance coverage, work with your healthcare provider to coordinate the insurance process, assist with filling your prescription through your preferred pharmacy, and provide refill reminders.

To learn more, visit the Lybalvi Co-Pay Savings Program or call 855-820-9624.

What To Know Before Taking Lybalvi

Before starting Lybalvi, your doctor may check or test your fasting blood sugar, fasting cholesterol and triglycerides, and your weight.

Tell your doctor if you have any allergies to olanzapine and samidorphan or any ingredients in Lybalvi.

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

Do not take Lybalvi if you are using opioids or are going through acute opioid withdrawal.

Lybalvi is also FDA approved to treat bipolar 1 disorder in adults.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Lybalvi, talk with your doctor about the risks and benefits.

There is a pregnancy registry for people who take Lybalvi during pregnancy. To learn more, visit the National Pregnancy Registry for Atypical Antipsychotics or call 866-961-2388.

Breastfed infants exposed to Lybalvi should be watched for too much sleepiness, irritability, poor feeding, and abnormal muscle movements.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Lybalvi?
In a four-week study of adults with schizophrenia, people taking Lybalvi had a 23.9-point reduction in PANSS total score. People taking placebo (an inactive treatment) had a 17.5-point drop. PANSS is a scale used to measure schizophrenia symptoms.

A larger drop means greater symptom improvement. The difference between Lybalvi and placebo was 6.4 points at week 4.

In a separate 24-week study, adding samidorphan did not appear to reduce the antipsychotic effect of olanzapine.

How long does Lybalvi take to work for schizophrenia?
In clinical studies of schizophrenia, symptom improvement with Lybalvi was measured at four weeks, and the medication showed a significant improvement compared with placebo at that time.

The available data does not specify exactly how soon people may start to feel better before this time point.

Can Lybalvi cause sleepiness with schizophrenia?
Yes. Lybalvi can cause sleepiness. In a study, 9 percent of people taking Lybalvi felt sleepy, compared with 2.2 percent taking placebo.

Sedation has also been reported. Lybalvi can affect thinking, judgment, and movement. Be careful when driving or using machines until you know how it affects you.