Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav? (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults
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- Breathing problems, including?slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.
- Mental health problems, including?confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves.?Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
- Sleepwalking.?XYWAV can cause sleepwalking which can cause injuries. Call your doctor if this occurs.
- Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution Prescribing Information.?Palo Alto, CA:?Jazz Pharmaceuticals, Inc.
- Billiard M, Sonka K. Idiopathic hypersomnia.?Sleep Med Rev. 2016 Oct;29:23-33. doi: 10.1016/j.smrv.2015.08.007. Epub 2015?Sep 3. PMID: 26599679.
- Trotti LM. Idiopathic Hypersomnia.?Sleep?Med Clin. 2017;12(3):331-344. doi:10.1016/j.jsmc.2017.03.009.
- American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
- Khan Z, Trotti LM. Central Disorders of Hypersomnolence: Focus on the Narcolepsies and Idiopathic Hypersomnia. Chest. 2015 Jul;148(1):262-273. doi: 10.1378/chest.14-1304.
- Jazz Pharmaceuticals, Inc, Data on file.
- Dauvilliers Y. Efficacy and Safety of Lower-Sodium Oxybate in a Phase 3, Placebo- Controlled, Double-Blind, Randomized Withdrawal Study in Adult Participants With Idiopathic Hypersomnia. Oral presentation at the?American Academy of Neurology?2021 Annual Meeting;?April 2021; Virtual.
- United States Drug Enforcement Agency. Drug Scheduling.?https://www.dea.gov/drug-scheduling.?Accessed?July 2021.
- Jazz Pharmaceuticals, Inc, Data on file. JZP258-2020-047-29 Oct 2020.
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition (DSM-5). 2020.
- Evangelista E, Lopez R, Dauvilliers Y. Update on treatment for idiopathic hypersomnia.?Expert Opin Investig Drugs. 2018 Feb;27(2):187-192. doi: 10.1080/13543784.2018.1417385. Epub 2018?Jan 3. PMID: 29250981.
- Ozaki A, Inoue Y, Hayashida K, Nakajima T, Honda M, Usui A, Komada Y, Kobayashi M, Takahashi K. Quality of life in patients with narcolepsy with cataplexy, narcolepsy without cataplexy, and idiopathic hypersomnia without long sleep time: comparison between patients on psychostimulants, drug-na?ve patients and the general Japanese population.?Sleep Med. 2012 Feb;13(2):200-6. doi: 10.1016/j.sleep.2011.07.014. Epub 2011?Dec 3. PMID: 22137109.
- Anderson KN, Pilsworth S, Sharples LD, Smith IE, Shneerson JM. Idiopathic hypersomnia: a study of 77 cases. Sleep. 2007 Oct;30(10):1274-81. doi: 10.1093/sleep/30.10.1274. PMID: 17969461; PMCID: PMC2266276.Anderson KN, Pilsworth S, Sharples LD, Smith IE, Shneerson JM. Idiopathic hypersomnia: a study of 77 cases.?Sleep. 2007 Oct;30(10):1274-81. doi: 10.1093/sleep/30.10.1274. PMID: 17969461; PMCID: PMC2266276.
- Masri TJ, Gonzales CG, Kushida CA. Idiopathic Hypersomnia.?Sleep Medicine Clinics. 2012 June;7(2):283-289. doi:?https://doi.org/10.1016/j.jsmc.2012.03.012
- Trotti LM, Arnulf I. Idiopathic Hypersomnia and Other Hypersomnia Syndromes. Neurotherapeutics. 2020?Sep 8. doi: 10.1007/s13311-020-00919-1. Epub ahead of print. PMID: 32901432.