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  • Title: Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav®) in Sleep Disorders: A Profile of Its Use.
    Author: Heo YA.
    Journal: CNS Drugs; 2022 May; 36(5):541-549. PubMed ID: 35357671.
    Abstract:
    Calcium, magnesium, potassium and sodium oxybates (Xywav®; hereafter referred to as lower-sodium oxybate), a new oxybate formulation with a greatly reduced sodium burden compared with previously approved sodium oxybate (Xyrem®), is approved for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adults and children aged ≥ 7 years with narcolepsy, and is the first drug approved for the treatment of idiopathic hypersomnia in adults in the USA. In two pivotal, double-blind, placebo-controlled, phase 3 trials of randomized-withdrawal design, lower-sodium oxybate effectively improved cataplexy and EDS in adults with narcolepsy, and EDS and overall idiopathic hypersomnia symptoms in adults with idiopathic hypersomnia during open-label titration and optimization periods. At the end of the double-blind, randomized withdrawal period, participants randomized to switch to placebo experienced significant worsening in these symptoms compared with those randomized to continue lower-sodium oxybate. Furthermore, worsening in patient- and clinical-rated global scales, as well as measures of health-related quality of life were also seen with placebo versus lower-sodium oxybate. Lower-sodium oxybate is generally well tolerated, with the tolerability profile being largely consistent to that seen with sodium oxybate. Narcolepsy and idiopathic hypersomnia are rare, chronic sleep disorders that can debilitate patients’ cognitive function, social functioning and health-related quality of life. They are primarily characterized by excessive daytime sleepiness (EDS) and often require long-term (even life-long) treatment to reduce symptoms and improve functioning. Sodium oxybate (Xyrem®) is an effective treatment option for cataplexy and EDS in patients with narcolepsy; however, its high sodium content may put patients at higher risk of increased blood pressure and cardiovascular disease. To reduce the excessive sodium intake associated with long-term therapy, lower-sodium oxybate (Xywav®), a new oxybate formulation with 92% less sodium content, has been developed. In the USA, it is approved for the treatment of cataplexy or EDS in adults and children aged ≥ 7 years with narcolepsy, and is the first drug approved for the treatment of idiopathic hypersomnia in adults. In pivotal phase 3 trials, following dose titration and optimization periods, participants randomized to discontinue lower-sodium oxybate and take placebo showed significant worsening in narcolepsy- and idiopathic hypersomnia-related symptoms, as well as health-related quality of life outcomes compared with participants randomized to continue lower-sodium oxybate. Lower-sodium oxybate is generally well tolerated, with its safety profile similar to that of sodium oxybate. Lower-sodium oxybate is a valuable treatment option for children and adults with narcolepsy and adults with idiopathic hypersomnia.
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