Xywav
Xywav is a medication used to treat cataplexy or excessive daytime sleepiness.[2][3] It contains a mixture of the oxybate salts calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate.[2] It is a central nervous system (CNS) depressant and it is taken by mouth.[2]
Manufactured by the Jazz Pharmaceuticals company, it was approved for medical use in the United States in July 2020.[2][4][5]
Medical uses
[edit]Xywav is indicated for the treatment of cataplexy or excessive daytime sleepiness in people aged seven years of age and older with narcolepsy;[2][6] and for idiopathic hypersomnia.[6][7]
Side effects
[edit]The US Food and Drug Administration (FDA) label for Xywav contains a boxed warning for central nervous system depression, abuse, and misuse.[2]
Breathing problems
[edit]Slowed breathing, trouble breathing, sleep apnea.[2]
Mental health problems
[edit]Confusion, hallucination, unusual or disturbing thoughts (abnormal thinking), anxiety, depression, suicidal thoughts or actions, increased tiredness, feelings of guilt or worthlessness, and difficulty concentrating.[2]
Other
[edit]Society and culture
[edit]Legal status
[edit]The sodium oxybate component of Xywav was granted orphan drug designation in November 1994 by the FDA.[8][6] Xywav is a prescription drug and a Schedule III controlled substance in the United States.[2]
Other names
[edit]In the testing phase of the drug, it was known as JZP-258.[9]
Calcium, magnesium, potassium, and sodium oxybate is another name for gamma hydroxybutyrate (GHB).[10][11]
References
[edit]- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ a b c d e f g h i j k "Xywav - calcium, magnesium, potassium, and sodium oxybates solution". DailyMed. Archived from the original on 13 August 2021. Retrieved 12 August 2021.
- ^ Halter MJ, Fratena CA (November 2021). "Sleep-Wake Medications". Varcarolis' Manual of Psychiatric Nursing Care. Elsevier Health Sciences. p. 398. ISBN 978-0-323-79306-3. Archived from the original on 20 June 2022. Retrieved 23 December 2021.
- ^ "Drug Approval Package: Xywav". U.S. Food and Drug Administration (FDA). 7 May 2021. Archived from the original on 13 August 2021. Retrieved 12 August 2021.
- ^ "Drug Approval Package: Xywav". U.S. Food and Drug Administration (FDA). 7 May 2021. Archived from the original on 27 December 2021. Retrieved 19 November 2021.
- ^ a b c "FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment". U.S. Food and Drug Administration (FDA) (Press release). 12 August 2021. Archived from the original on 12 August 2021. Retrieved 12 August 2021.
- ^ "Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults" (Press release). Jazz Pharmaceuticals. 12 August 2021. Archived from the original on 12 August 2021. Retrieved 12 August 2021 – via PR Newswire.
- ^ "Xywav Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Archived from the original on 13 August 2021. Retrieved 12 August 2021.
- ^ "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". Archived from the original on 20 September 2022. Retrieved 20 September 2022.
- ^ "Calcium, Magnesium, Potassium, and Sodium Oxybate: MedlinePlus Drug Information". American Society of Health-System Pharmacists. Archived from the original on 6 June 2023. Retrieved 29 December 2023.
- ^ "F.D.A. Approves GHB, a 'Date Rape' Drug, for Narcolepsy Patients". The New York Times. 12 August 2021. Archived from the original on 13 August 2021. Retrieved 13 August 2021.
