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 |
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Identifiers | |
KEGG |
Xywav (calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate) is a fixed-dose combination medication used to treat cataplexy or excessive daytime sleepiness. [1] [2] It contains a mixture of 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]
It is manufactured by Jazz Pharmaceuticals and was approved for medical use in the United States in July 2020. [1] [3]
Xywav is indicated for the treatment of cataplexy or excessive daytime sleepiness in people aged seven years of age and older with narcolepsy; [1] [4] and for idiopathic hypersomnia. [4] [5]
Xywav is composed of 43.8% calcium, 26% potassium, 19.2% magnesium, and 8% sodium oxybate by weight in an oral solution. [1] The concentration of oxybate salts in solution is 0.5 g/ml, equivalent to .413 grams of total oxybate. [1]
The US Food and Drug Administration label for Xywav contains a boxed warning for central nervous system depression, abuse, and misuse. [1]
Slowed breathing, trouble breathing, sleep apnea. [1]
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]
Xywav was granted orphan drug designation by the US Food and Drug Administration. [4] [6]
Xywav is a prescription drug and a Schedule III controlled substance in the United States. [1]
In the testing phase of the drug, it was known as JZP-258. [7]
Calcium, magnesium, potassium, and sodium oxybate is another name for gamma hydroxybutyrate (GHB). [8] [9]