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Sodium Oxybate (Xyrem®): A New and Effective Treatment for Narcolepsy with Cataplexy

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Drug Treatment of Sleep Disorders

Part of the book series: Milestones in Drug Therapy ((MDT))

Abstract

Sodium oxybate (SXB; Xyrem®) is the sodium salt of gamma hydroxybutyric acid (GHB). SXB has been approved in the United States for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients with narcolepsy and in the European Union for the treatment of narcolepsy with cataplexy. Randomized clinical trials have shown that SXB is highly effective in reducing the frequency of cataplexy and in reducing EDS in patients with narcolepsy. In addition, SXB improved sleep architecture by increasing delta power and the duration of slow-wave sleep and by reducing nocturnal awakenings in patients with narcolepsy with cataplexy. Global function and health-related quality of life were also improved by SXB. The majority of the above effects are dose-related. SXB is administered orally after mixing with water. It is rapidly absorbed and eliminated with a mean elimination half-life of 30–60 min, and its duration of action is 2–4 h. Therefore, SXB must be administered twice during the night to consolidate 6–8 h of nocturnal sleep. In general, SXB is well tolerated, and the most commonly reported adverse events are nausea, vomiting, dizziness, and urinary incontinence. SXB is a drug with potential for misuse and abuse. In addition, SXB has a narrow safety margin with a risk of toxicity. Therefore, strict risk-management strategies and rigorous adherence to the titration schedule are essential.

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Acknowledgments

This work was supported by the National Plan for Science and Technology program by the King Saud University Project in Saudi Arabia.

Competing Interests/Disclosure Statement

S.R. Pandi-Perumal is a stockholder and the President and Chief Executive Officer of Somnogen Canada Inc., a Canadian Corporation. He declares that he has no competing interests that could be perceived to influence the content of this article. AS BaHammam declares that he has no proprietary, financial, professional, or any other personal interest of any nature in any product or services and/or company that could be construed or considered to be a potential conflict of interest and that may have influenced the views expressed in this chapter.

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Authors and Affiliations

  1. College of Medicine, National Plan for Science and Technology, University Sleep Disorders Center, King Saud University, Box 225503, Riyadh, 11324, Saudi Arabia

    Ahmed S. BaHammam

  2. Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287-7413, USA

    David Nelson Neubauer

  3. Department of Population Health, Center for Healthful Behavior Change (CHBC), Division of Health and Behavior, Clinical & Translational Research Institute, New York University Medical Center, 227 East 30th Street (between 2nd and 3rd Ave), Floor # 6 – 632E, New York, NY, 10016, USA

    Seithikurippu R. Pandi-Perumal

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  1. Ahmed S. BaHammam
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  2. David Nelson Neubauer
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Correspondence to Ahmed S. BaHammam .

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  1. Independent Pharmaceutical Consultant, Barcelona, Spain

    Antonio Guglietta

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BaHammam, A.S., Neubauer, D.N., Pandi-Perumal, S.R. (2015). Sodium Oxybate (Xyrem®): A New and Effective Treatment for Narcolepsy with Cataplexy. In: Guglietta, A. (eds) Drug Treatment of Sleep Disorders. Milestones in Drug Therapy. Springer, Cham. https://doi.org/10.1007/978-3-319-11514-6_11

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