Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav®) in Sleep Disorders: A Profile of Its Use

<p><b>Declarations</b></p> <p> </p> <p><b>Funding</b> The preparation of this review was not supported by any external funding.</p> <p> </p> <p><b>Authorship and Conflict of interest</b> Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p> <p> </p> <p><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p> <p> </p> <p>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a><b></b></p><p><br></p><p>Abstract</p> <p> </p> <p>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 EDS and cataplexy in adults with narcolepsy, and EDS and overall 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 of 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. <br></p><p><br></p><p>© Springer Nature Switzerland AG 2022<br></p><p><br></p>