The FDA has recently approved Xywav for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Another drug Xyrem is available for the same indication in the US. What is a principal advantage of using Xywav over Xyrem?
a. Less side effects
b. Less potential for abuse
c. Low sodium contents
d. More potency
The active ingredients found in Xywav is (calcium, magnesium, potassium, and sodium oxybates) oral solution. It is for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Xywav is an oxybate product with a unique composition of cations resulting in 92 percent less sodium - or approximately 1,000 to 1,500 mg/night - than sodium oxybate at the recommended dosage range of 6 to 9 grams.
Multiple Xywav dosing options are available for adult and pediatric patients. Prescribers can titrate Xywav into unequal doses taken over the course of the night. When patients start Xywav after sodium oxybate, Xywav treatment is initiated at the same dose and regimen as sodium oxybate (gram for gram) and titrated as needed based on efficacy and tolerability.
Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association. Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease.
Xyrem (Sodium oxybate) carries warnings about its high sodium content,10 and was previously the only product approved to treat both cataplexy and EDS in patients with narcolepsy 7 years of age and older and designated as a standard of care for the treatment of cataplexy and EDS by the American Academy of Sleep Medicine.
Xywav has a Boxed Warning as a central nervous system depressant, and for its potential for abuse and misuse. Because of the risks of CNS depression and abuse and misuse, Xywav is available only through a restricted program under a REMS called the Xywav and Xyrem REMS Program.
Most common adverse reactions in adults are headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety and vomiting.
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