Xywav
{{Short description|Combination drug}}
{{distinguish|Xyrem}}
{{Use American English|date=August 2021}}
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{{Infobox drug
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| 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
| Drugs.com = {{drugs.com|cons|calcium-oxybate-magnesium-oxybate-potassium-oxybate-and-sodium-oxybate}}
| MedlinePlus = a621001
| DailyMedID = Calcium magnesium potassium and sodium oxybates
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| routes_of_administration = By mouth
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| legal_US = Schedule III
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| KEGG = D12131
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| synonyms = JZP-258
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Xywav is a medication used to treat cataplexy or excessive daytime sleepiness.{{cite book | vauthors = Halter MJ, Fratena CA | chapter = Sleep-Wake Medications | chapter-url = https://books.google.com/books?id=zNROEAAAQBAJ&pg=PA398 | title = Varcarolis' Manual of Psychiatric Nursing Care | publisher = Elsevier Health Sciences | date = November 2021 | page = 398 | isbn = 978-0-323-79306-3 | access-date = 23 December 2021 | archive-date = 20 June 2022 | archive-url = https://web.archive.org/web/20220620002630/https://books.google.com/books?id=zNROEAAAQBAJ&pg=PA398 | url-status = live }} 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.{{cite web | title=Drug Approval Package: Xywav | website=U.S. Food and Drug Administration (FDA) | date=7 May 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm | access-date=12 August 2021 | archive-date=13 August 2021 | archive-url=https://web.archive.org/web/20210813063418/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm | url-status=live }}{{cite web | title=Drug Approval Package: Xywav | website=U.S. Food and Drug Administration (FDA) | date=7 May 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm | access-date=19 November 2021 | archive-date=27 December 2021 | archive-url=https://web.archive.org/web/20211227225137/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm | url-status=live }}
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.{{cite press release | title=FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment | website=U.S. Food and Drug Administration (FDA) | date=12 August 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-grants-first-its-kind-indication-chronic-sleep-disorder-treatment | access-date=12 August 2021 | archive-date=12 August 2021 | archive-url=https://web.archive.org/web/20210812203819/http://www.fda.gov/news-events/press-announcements/fda-grants-first-its-kind-indication-chronic-sleep-disorder-treatment | url-status=live }}{{cite press release | title=Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults | publisher=Jazz Pharmaceuticals | via=PR Newswire | date=12 August 2021 | url=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 | access-date=12 August 2021 | archive-date=12 August 2021 | archive-url=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 | url-status=live }}
Chemical composition
Xywav is composed of 43.8% calcium, 26% potassium, 19.2% magnesium, and 8% sodium oxybate by weight in an oral solution. The concentration of oxybate salts in solution is 0.5 g/ml, equivalent to .413 grams of total oxybate.{{Cite web |title=Xywav prescribing information |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s036,212690s001s006lbl.pdf}}
Side effects
The US Food and Drug Administration (FDA) label for Xywav contains a boxed warning for central nervous system depression, abuse, and misuse.
= Respiratory =
Slowed breathing, trouble breathing, sleep apnea.
= Psychiatric =
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 =
Society and culture
= Legal status =
The sodium oxybate component of Xywav was granted orphan drug designation in November 1994 by the FDA.{{cite web | title=Xywav Orphan Drug Designations and Approvals | website=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=85894 | access-date=12 August 2021 | archive-date=13 August 2021 | archive-url=https://web.archive.org/web/20210813064149/https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=85894 | url-status=live }} Xywav is a prescription drug and a Schedule III controlled substance in the United States.
= Other names =
Calcium, magnesium, potassium, and sodium oxybate is another name for gamma hydroxybutyrate (GHB).{{cite web | title=Calcium, Magnesium, Potassium, and Sodium Oxybate: MedlinePlus Drug Information | website=American Society of Health-System Pharmacists | url=https://medlineplus.gov/druginfo/meds/a621001.html | access-date=29 December 2023 | archive-date=6 June 2023 | archive-url=https://web.archive.org/web/20230606185732/https://medlineplus.gov/druginfo/meds/a621001.html | url-status=live }}{{cite news | title=F.D.A. Approves GHB, a 'Date Rape' Drug, for Narcolepsy Patients | website=The New York Times | date=12 August 2021 | url=https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html | access-date=13 August 2021 | archive-date=13 August 2021 | archive-url=https://web.archive.org/web/20210813063417/https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html | url-status=live }}
References
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{{Stimulants}}
{{Hypnotics}}
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