FDA Warns Against Using Xyrem with Alcohol or Drugs Causing Respiratory Depression

Karen Lee Richards Health Guide
  • Although Xyrem (sodium oxybate) failed to gain FDA approval for the treatment of fibromyalgia, it is sometimes prescribed off-label to treat the sleep problems that commonly accompany FM. Thus far, Xyrem only has FDA approval to reduce attacks of muscle weakness (cataplexy) and treat daytime sleepiness in patients with narcolepsy.


    This week the FDA reminded both healthcare professionals and patients that the combined use of Xyrem with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label.

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    In addition to alcohol, medications that should be avoided when taking Xyrem include:

    • Opioid analgesics

    • Benzodiazepines

    • Sedating antidepressants or antipsychotics

    • Insomnia drugs

    • General anesthetics

    • Muscle relaxants

    The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.


    Sodium oxybate, the active ingredient of Xyrem, is also known as gamma-hydroxybutyrate (GHB). GHB is a known drug of abuse that has been associated with central nervous system (CNS) adverse events, including death. Even at recommended doses, Xyrem can cause confusion, depression, and other neuropsychiatric events.




    Xyrem (sodium oxybate): Drug Safety Communication – Warning Against Use With Alcohol or Drugs Causing Respiratory Depression.” U.S. Food and Drug Administration. December 17, 2012.

Published On: December 20, 2012