Chemistry:Xywav
| Combination of | |
|---|---|
| Calcium oxybate | Central nervous system depressant |
| Magnesium oxybate | Central nervous system depressant |
| Potassium oxybate | Central nervous system depressant |
| Sodium oxybate | Central nervous system depressant |
| Clinical data | |
| Trade names | Xywav |
| Other names | JZP-258 |
| AHFS/Drugs.com | Micromedex Detailed Consumer Information |
| MedlinePlus | a621001 |
| License data | |
| Routes of administration | By mouth |
| ATC code |
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| Legal status | |
| Legal status |
|
| Identifiers | |
| KEGG | |
Xywav is a medication used to treat cataplexy or excessive daytime sleepiness.[1][2] It contains a mixture the oxybate salts calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate.[1] It is a central nervous system (CNS) depressant and it is taken by mouth.[1]
Manufactured by the Jazz Pharmaceuticals company, it was approved for medical use in the United States in July 2020.[1][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;[1][5] 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.[1]
Breathing problems
Slowed breathing, trouble breathing, sleep apnea.[1]
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.[1]
Other
Society and culture
Legal status
The sodium oxybate component of Xywav was granted orphan drug designation in November 1994 by the FDA.[7][5] 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]
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 "Xywav - calcium, magnesium, potassium, and sodium oxybates solution". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e0ae43a-037f-42af-8e23-a0e51d75abe8.
- ↑ "Sleep-Wake Medications". Varcarolis' Manual of Psychiatric Nursing Care. Elsevier Health Sciences. November 2021. p. 398. ISBN 978-0-323-79306-3. https://books.google.com/books?id=zNROEAAAQBAJ&pg=PA398. Retrieved 23 December 2021.
- ↑ "Drug Approval Package: Xywav". 7 May 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm.
- ↑ "Drug Approval Package: Xywav". 7 May 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.cfm.
- ↑ 5.0 5.1 5.2 "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". https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=85894.
- ↑ "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". https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-xywavtm-calcium.
- ↑ "Calcium, Magnesium, Potassium, and Sodium Oxybate: MedlinePlus Drug Information". https://medlineplus.gov/druginfo/meds/a621001.html.
- ↑ "F.D.A. Approves GHB, a 'Date Rape' Drug, for Narcolepsy Patients". 12 August 2021. https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html.
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