Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Xyrem for Pediatric Narcolepsy

Pharmacy Times news release; 2018 Oct 28

The US Food and Drug Administration (FDA) has approved Jazz Pharmaceuticals' Xyrem (sodium oxybate) for the treatment of pediatric patients aged 7 to 17 years with narcolepsy. The drug had previously been approved for use in adult patients. Jazz Pharmaceuticals is headquartered in Dublin, Ireland.

Indications: Xyrem is a central nervous system (CNS) depressant that was FDA-approved in 2002. It is indicated for the treatment of cataplexy and daytime sleepiness (EDS) in patients aged ≥7 years with narcolepsy.

Dosage/administration: The recommended starting dosage, titration regimen, and maximum

total nightly dosage are based on body weight. Each dose should be taken while in bed and the patient should lie down after dosing. Patients should allow 2 hours after eating before dosing.

Both doses should be prepared prior to bedtime; each dose should be diluted with approximately ¼ cup of water in pharmacy-provided containers.

Adverse reactions: Most common adverse reactions in pediatric patients (≥5%) were enuresis,

nausea, headache, vomiting, weight decreased, decreased appetite, and dizziness.


Drug receives FDA approval for treating narcolepsy in pediatric patients. [news release]. Dublin, Ireland: Jazz Pharmaceuticals. October 28, 2018. Accessed November 5, 2018.