Effectiveness and Safety of Low-Sodium Oxybate in Participants with Idiopathic Hypersomnia: Primary Results from the DUET Study

American Academy of Sleep Medicine. International classification of sleep disorders—third edition, text revision. Darien: American Academy of Sleep Medicine; 2023.

Google Scholar 

Lammers GJ, Bassetti CLA, Dolenc-Groselj L, Jennum PJ, Kallweit U, Khatami R, et al. Diagnosis of central disorders of hypersomnolence: a reappraisal by European experts. Sleep Med Rev. 2020;52:101306. https://doi.org/10.1016/j.smrv.2020.101306.

Article  PubMed  Google Scholar 

Schneider LD, Cairns A, Ruoff C, Bogan RK. Current knowledge on the pathophysiology of idiopathic hypersomnia and potential mechanisms of action for low-sodium oxybate treatment. J Clin Sleep Med. 2025;21(7):1245–60. https://doi.org/10.5664/jcsm.11566.

Article  PubMed  PubMed Central  Google Scholar 

Fronczek R, Arnulf I, Baumann CR, Maski K, Pizza F, Trotti LM. To split or to lump? Classifying the central disorders of hypersomnolence. Sleep. 2020;43(8):zsaa044. https://doi.org/10.1093/sleep/zsaa044.

Article  PubMed  PubMed Central  Google Scholar 

Dauvilliers Y, Bogan RK, Arnulf I, Scammell TE, St Louis EK, Thorpy MJ. Clinical considerations for the diagnosis of idiopathic hypersomnia. Sleep Med Rev. 2022;66:101709.

Article  CAS  PubMed  Google Scholar 

Acquavella J, Mehra R, Bron M, Suomi JMH, Hess GP. Prevalence of narcolepsy, other sleep disorders, and diagnostic tests from 2013–2016: insured patients actively seeking care. J Clin Sleep Med. 2020;16(8):1255–63.

Article  PubMed  PubMed Central  Google Scholar 

Saad R, Black J, Bogan RK, Jensen ET, Lillaney P, Prince P, Estrin A, Whalen M, Macfadden W, Ni W, Plante DT, editors. Diagnosed prevalence of idiopathic hypersomnia among adults in the United States [poster]. Annual meeting of the academy of managed care pharmacy nexus; 2023 October 16–19; Orlando, FL.

Plante DT, Hagen EW, Barnet JH, Mignot E, Peppard PE. Prevalence and course of idiopathic hypersomnia in the Wisconsin Sleep Cohort study. Neurology. 2024;102(2):e207994. https://doi.org/10.1212/WNL.0000000000207994.

Article  PubMed  Google Scholar 

Ohayon MM, Dauvilliers Y, Reynolds CF 3rd. Operational definitions and algorithms for excessive sleepiness in the general population: implications for DSM-5 nosology. Arch Gen Psychiatry. 2012;69(1):71–9. https://doi.org/10.1001/archgenpsychiatry.2011.1240.

Article  PubMed  PubMed Central  Google Scholar 

Whalen M, Roy B, Steininger T, Dronamraju N, Enson D, editors. Patient perspective on idiopathic hypersomnia: impact on quality of life and satisfaction with the diagnostic process and management [poster 157]. Annual meeting of the associated professional sleep societies; 2022 June 4–8, 2022; Charlotte, NC.

Alexander JK, Markt SC, Whalen M, Carlyle M, Drachenberg C, White J, Casstevens C, Dick LL, Beaty S, Ruoff CM, editors. Prevalence and severity of sleep inertia among individuals with idiopathic hypersomnia [poster 557]. Annual meeting of the associated professional sleep societies; 2025 June 8–11, 2025; Seattle, WA.

Trotti LM. Waking up is the hardest thing i do all day: sleep inertia and sleep drunkenness. Sleep Med Rev. 2017;35:76–84. https://doi.org/10.1016/j.smrv.2016.08.005.

Article  PubMed  Google Scholar 

Arnulf I, Leu-Semenescu S, Dodet P. Precision medicine for idiopathic hypersomnia. Sleep Med Clin. 2022;17(3):379–98. https://doi.org/10.1016/j.jsmc.2022.06.016.

Article  PubMed  Google Scholar 

Trotti LM, Ong JC, Plante DT, Friederich Murray C, King R, Bliwise DL. Disease symptomatology and response to treatment in people with idiopathic hypersomnia: initial data from the Hypersomnia Foundation Registry. Sleep Med. 2020;75:343–9. https://doi.org/10.1016/j.sleep.2020.08.034.

Article  PubMed  PubMed Central  Google Scholar 

American Academy of Sleep Medicine. Idiopathic hypersomnia. International classification of sleep disorders, 3rd ed. Darien: American Academy of Sleep Medicine; 2014.

Google Scholar 

American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

Book  Google Scholar 

Ohayon MM, Reynolds CF 3rd, Dauvilliers Y. Excessive sleep duration and quality of life. Ann Neurol. 2013;73(6):785–94. https://doi.org/10.1002/ana.23818.

Article  PubMed  PubMed Central  Google Scholar 

Stevens J, Schneider LD, Husain A, Ito D, Fuller DS, Zee PC, et al. Impairment in functioning and quality of life in patients with idiopathic hypersomnia: the Real World Idiopathic Hypersomnia Outcomes Study (ARISE). Nat Sci Sleep. 2023;15:593–606.

Article  PubMed  PubMed Central  Google Scholar 

Wasling HB, Bornstein A, Wasling P. Quality of life and procrastination in post-H1N1 narcolepsy, sporadic narcolepsy and idiopathic hypersomnia, a Swedish cross-sectional study. Sleep Med. 2020;76:104–12. https://doi.org/10.1016/j.sleep.2020.10.014.

Article  PubMed  Google Scholar 

Ozaki A, Inoue Y, Hayashida K, Nakajima T, Honda M, Usui A, et al. Quality of life in patients with narcolepsy with cataplexy, narcolepsy without cataplexy, and idiopathic hypersomnia without long sleep time: comparison between patients on psychostimulants, drug-naïve patients and the general Japanese population. Sleep Med. 2012;13(2):200–6. https://doi.org/10.1016/j.sleep.2011.07.014.

Article  PubMed  Google Scholar 

Rassu AL, Evangelista E, Barateau L, Chenini S, Lopez R, Jaussent I, et al. Idiopathic hypersomnia severity scale to better quantify symptoms severity and their consequences in idiopathic hypersomnia. J Clin Sleep Med. 2022;18(2):617–29. https://doi.org/10.5664/jcsm.9682.

Article  PubMed  PubMed Central  Google Scholar 

Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, CIII [prescribing information]. Palo Alto: Jazz Pharmaceuticals, Inc.; 2025.

Szarfman A, Kuchenberg T, Soreth J, Lajmanovich S. Declaring the sodium content of drug products. N Engl J Med. 1995;333(19):1291. https://doi.org/10.1056/nejm199511093331917.

Article  CAS  PubMed  Google Scholar 

US Food and Drug Administration. Clinical review for Binosto, NDA 202344; 2012 [February 7, 2012]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344Orig1s000MedR.pdf.

US Food and Drug Administration. Quantitative labeling of sodium, potassium, and phosphorus for human over-the-counter and prescription drug products. Guidance for industry. Silver Spring, MD: US Food and Drug Administration; 2022 [17 September 2025]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug.

Xywav [Canadian product monograph including patient medication information]. Dublin, Ireland: Jazz Pharmaceuticals Ireland Ltd.; 2023.

Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Sonka K, Thorpy MJ, et al. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022;21(1):53–65.

Article  CAS  PubMed  Google Scholar 

Morse AM, Chen A, Steininger TL, Macfadden W. Effects of lower-sodium oxybate on 24-hour total sleep time: data from a phase 3 clinical study in adults with idiopathic hypersomnia [poster 119]. Biennial World Sleep; 2022 March 11-16, 2022; Rome, Italy.

Thorpy MJ, Arnulf I, Foldvary-Schaefer N, Morse AM, Šonka K, Chandler P, et al. Efficacy and safety of lower-sodium oxybate in an open-label titration period of a phase 3 clinical study in adults with idiopathic hypersomnia. Nat Sci Sleep. 2022;14:1901–17.

Article  PubMed  PubMed Central  Google Scholar 

Morse AM, Bogan RK, Roy A, Thorpy MJ. Dosing optimization of low-sodium oxybate in narcolepsy and idiopathic hypersomnia in adults: consensus recommendations. Neurol Ther. 2024;13(3):785–807. https://doi.org/10.1007/s40120-024-00607-8.

Article  PubMed  PubMed Central  Google Scholar 

Nichols DA, Steininger TL, Fuller DS, Kirby MT, Barker EC, Whalen M, et al. A patient-centric clinical trial design to comprehensively evaluate low-sodium oxybate in people with idiopathic hypersomnia or narcolepsy. Neurol Ther. 2025;14(4):1705–27. https://doi.org/10.1007/s40120-025-00745-7.

Article  PubMed  PubMed Central  Google Scholar 

Berry RB, Quan SF, Abreu AR, Bibbs ML, DelRosso L, Harding SM, et al. The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications, version 3. Darien: American Academy of Sleep Medicine; 2023.

Google Scholar 

Johns MW. Sleepiness in different situations measured by the Epworth Sleepiness Scale. Sleep. 1994;17(8):703–10. https://doi.org/10.1093/sleep/17.8.703.

Article  CAS  PubMed  Google Scholar 

Dauvilliers Y, Evangelista E, Barateau L, Lopez R, Chenini S, Delbos C, et al. Measurement of symptoms in idiopathic hypersomnia: the Idiopathic Hypersomnia Severity Scale. Neurology. 2019;92(15):e1754–62. https://doi.org/10.1212/wnl.0000000000007264.

Article  PubMed  Google Scholar 

Chasens ER, Ratcliffe SF, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009;32(7):915–9.

Article  PubMed  PubMed Central  Google Scholar 

Iverson GL, Lam RW. Rapid screening for perceived cognitive impairment in major depressive disorder. Ann Clin Psychiatry. 2013;25(2):135–40.

Article  PubMed  Google Scholar 

Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993;4(5):353–65. https://doi.org/10.2165/00019053-199304050-00006.

Article  CAS  PubMed 

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