Xywav Explained

Xywav should not be confused with Xyrem.

Type:combo
Component1:Calcium oxybate
Class1:Central nervous system depressant
Component2:Magnesium oxybate
Class2:Central nervous system depressant
Component3:Potassium oxybate
Class3:Central nervous system depressant
Component4:Sodium oxybate
Class4:Central nervous system depressant
Tradename:Xywav
Dailymedid:Calcium magnesium potassium and sodium oxybates
Routes Of Administration:By mouth
Atc Prefix:None
Legal Us:Schedule III
Legal Us Comment:[1]
Kegg:D12131
Synonyms:JZP-258

Xywav is a medication used to treat cataplexy or excessive daytime sleepiness.[2] It contains a mixture of the oxybate salts calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. It is a central nervous system (CNS) depressant and it is taken by mouth.

Manufactured by the Jazz Pharmaceuticals company, it was approved for medical use in the United States in July 2020.[3] [4]

Medical uses

Xywav is indicated for the treatment of cataplexy or excessive daytime sleepiness in people aged seven years of age and older with narcolepsy; and for idiopathic hypersomnia.[5] [6]

Side effects

The US Food and Drug Administration (FDA) label for Xywav contains a boxed warning for central nervous system depression, abuse, and misuse.

Breathing problems

Slowed breathing, trouble breathing, sleep apnea.

Mental health problems

Confusion, hallucination, unusual or disturbing thoughts (abnormal thinking), anxiety, depression, suicidal thoughts or actions, increased tiredness, feelings of guilt or worthlessness, and difficulty concentrating.

Other

Sleepwalking.

Society and culture

Legal status

The sodium oxybate component of Xywav was granted orphan drug designation in November 1994 by the FDA.[7] Xywav is a prescription drug and a Schedule III controlled substance in the United States.[1]

Other names

In the testing phase of the drug, it was known as JZP-258.[8]

Calcium, magnesium, potassium, and sodium oxybate is another name for gamma hydroxybutyrate (GHB).[9] [10]

Notes and References

  1. Web site: Xywav - calcium, magnesium, potassium, and sodium oxybates solution . DailyMed . 12 August 2021 . 13 August 2021 . https://web.archive.org/web/20210813063420/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e0ae43a-037f-42af-8e23-a0e51d75abe8 . live .
  2. Book: Halter MJ, Fratena CA . Sleep-Wake Medications . https://books.google.com/books?id=zNROEAAAQBAJ&pg=PA398 . Varcarolis' Manual of Psychiatric Nursing Care . Elsevier Health Sciences . November 2021 . 398 . 978-0-323-79306-3 . 23 December 2021 . 20 June 2022 . https://web.archive.org/web/20220620002630/https://books.google.com/books?id=zNROEAAAQBAJ&pg=PA398 . live .
  3. Web site: Drug Approval Package: Xywav . U.S. Food and Drug Administration (FDA) . 7 May 2021 . 12 August 2021 . 13 August 2021 . https://web.archive.org/web/20210813063418/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm . live .
  4. Web site: Drug Approval Package: Xywav . U.S. Food and Drug Administration (FDA) . 7 May 2021 . 19 November 2021 . 27 December 2021 . https://web.archive.org/web/20211227225137/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm . live .
  5. FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment . U.S. Food and Drug Administration (FDA) . 12 August 2021 . 12 August 2021 . 12 August 2021 . https://web.archive.org/web/20210812203819/http://www.fda.gov/news-events/press-announcements/fda-grants-first-its-kind-indication-chronic-sleep-disorder-treatment . live .
  6. Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults . Jazz Pharmaceuticals . PR Newswire . 12 August 2021 . 12 August 2021 . 12 August 2021 . https://web.archive.org/web/20210812185103/https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-for-idiopathic-hypersomnia-in-adults-301354616.html . live .
  7. Web site: Xywav Orphan Drug Designations and Approvals . U.S. Food and Drug Administration (FDA) . 12 August 2021 . 13 August 2021 . https://web.archive.org/web/20210813064149/https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=85894 . live .
  8. Web site: 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 . 20 September 2022 . 20 September 2022 . https://web.archive.org/web/20220920183456/https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-xywavtm-calcium . live .
  9. Web site: Calcium, Magnesium, Potassium, and Sodium Oxybate: MedlinePlus Drug Information . American Society of Health-System Pharmacists . 29 December 2023 . 6 June 2023 . https://web.archive.org/web/20230606185732/https://medlineplus.gov/druginfo/meds/a621001.html . live .
  10. News: F.D.A. Approves GHB, a 'Date Rape' Drug, for Narcolepsy Patients . . 12 August 2021 . 13 August 2021 . 13 August 2021 . https://web.archive.org/web/20210813063417/https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html . live .

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