FDA label
What is Lybalvi used for?
Lybalvi contains olanzapine and samidorphan l-malate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “LYBALVI is indicated for the treatment of: Schizophrenia in adults; Bipolar I disorder in adults.”
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Lybalvi, tablet, film coated
Indications and Usage, quoted from the label by Alkermes, Inc. (NDA213378). Cross-references to other label sections are left out.
LYBALVI is indicated for the treatment of:
- Schizophrenia in adults
- Bipolar I disorder in adults
- Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
- Maintenance monotherapy treatment
Source: DailyMed label, set id 32ffddd1-4e2b-45d9-9b36-bb730167ec80, version 16, effective January 31, 2026. NDC 65757-651, one of 4 listings for this product.
Questions
What is Lybalvi used for?
The FDA label says: “LYBALVI is indicated for the treatment of: Schizophrenia in adults; Bipolar I disorder in adults.”
What drug class is Lybalvi?
FDA lists olanzapine and samidorphan l-malate in the Atypical Antipsychotic and Opioid Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.