From Wikipedia, the free encyclopedia
Combination of
OlanzapineAtypical antipsychotic
SamidorphanOpioid antagonist
Clinical data
Trade namesLybalvi
Other namesALKS-3831; OLZ/SAM
AHFS/Drugs.comMicromedex Detailed Consumer Information
License data
Routes of
By mouth
ATC code
  • None
Legal status
Legal status

Olanzapine/samidorphan (OLZ/SAM), sold under the brand name Lybalvi, is a fixed-dose combination medication for the treatment of schizophrenia and bipolar I disorder.[1] It contains olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist.[1][2][3] Samidorphan reduces the weight gain associated with olanzapine while still allowing olanzapine to exert its therapeutic effect.[4][5] The formulation was approved for medical use in the United States in May 2021.[1][6]


  1. ^ a b c d https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf[bare URL PDF]
  2. ^ Maric NP, Jovicic MJ, Mihaljevic M, Miljevic C (2016). "Improving Current Treatments for Schizophrenia". Drug Development Research. 77 (7): 357–367. doi:10.1002/ddr.21337. PMID 27633376. S2CID 205750190.
  3. ^ Fellner C (2017). "New Schizophrenia Treatments Address Unmet Clinical Needs". P T. 42 (2): 130–134. PMC 5265239. PMID 28163559.
  4. ^ Citrome L, Graham C, Simmons A, Jiang Y, Todtenkopf MS, Silverman B, DiPetrillo L, Cummings H, Sun L, McDonnell D (2021). "An Evidence-Based Review of OLZ/SAM for Treatment of Adults with Schizophrenia or Bipolar I Disorder". Neuropsychiatr Dis Treat. 17: 2885–2904. doi:10.2147/NDT.S313840. PMC 8437420. PMID 34526769.
  5. ^ Paik J (August 2021). "Olanzapine/Samidorphan: First Approval". Drugs. 81 (12): 1431–1436. doi:10.1007/s40265-021-01568-0. PMID 34304374. S2CID 236215923.
  6. ^ "Drug Approval Package: Lybalvi". U.S. Food and Drug Administration (FDA). 26 June 2021. Retrieved 12 September 2021.

External links[edit]

  • "Olanzapine". Drug Information Portal. U.S. National Library of Medicine.
  • "Samidorphan". Drug Information Portal. U.S. National Library of Medicine.