Evidence of Accidental Dosing Errors with Immediate-Release Sodium Oxybate: Data from the US Food and Drug Administration Adverse Event Reporting System

Author:

Gudeman JenniferORCID,Burroughs Danielle

Funder

Avadel Pharmaceuticals

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference19 articles.

1. Broughton R, Mamelak M. The treatment of narcolepsy-cataplexy with nocturnal gamma-hydroxybutyrate. Can J Neurol Sci. 1979;6(1):1–6. https://doi.org/10.1017/s0317167100119304.

2. Jazz Pharmaceuticals. Jazz Pharmaceuticals, Inc. Release: Xyrem® Receives FDA Approval for the Treatment of Excessive Daytime Sleepiness in Patients With Narcolepsy. 2005. https://www.biospace.com/article/releases/jazz-pharmaceuticals-inc-release-xyrem-r-receives-fda-approval-for-the-treatment-of-excessive-daytime-sleepiness-in-patients-with-narcolepsy-/. Accessed 15 Jul 2022.

3. Jazz Pharmaceuticals. Jazz Pharmaceuticals Announces FDA Approval of Xyrem® (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients. 2018. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-approval-xyremr-sodium. Accessed 15 Jul 2022.

4. Jazz Pharmaceuticals. Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy. 2020. http://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-xywavtm-calcium. Accessed 15 Oct 2020.

5. Jazz Pharmaceuticals. XYREM (sodium oxybate oral solution, CIII). Full Prescribing Information. California: Jazz Pharmaceuticals; 2022.

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