Symptom Severity and Treatment Satisfaction in Patients with Idiopathic Hypersomnia: The Real World Idiopathic Hypersomnia Outcomes Study (ARISE)

References

• American Academy of Sleep Medicine. Idiopathic hypersomnia. In: International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
   Google Scholar
• Trotti LM. Idiopathic hypersomnia. Sleep Med Clin. 2017;12(3):331–344. doi:10.1016/j.jsmc.2017.03.009
   PubMed Web of Science ®Google Scholar
• Pizza F, Jaussent I, Lopez R, et al. Car crashes and central disorders of hypersomnolence: a French study. PLoS One. 2015;10(6):e0129386. doi:10.1371/journal.pone.0129386
   PubMed Web of Science ®Google Scholar
• Vernet C, Arnulf I. Idiopathic hypersomnia with and without long sleep time: a controlled series of 75 patients. Sleep. 2009;32(6):753–759. doi:10.1093/sleep/32.6.753
   PubMed Web of Science ®Google Scholar
• Ozaki A, Inoue Y, Nakajima T, et al. Health-related quality of life among drug-naive patients with narcolepsy with cataplexy, narcolepsy without cataplexy, and idiopathic hypersomnia without long sleep time. J Clin Sleep Med. 2008;4(6):572–578. doi:10.5664/jcsm.27352
   PubMed Web of Science ®Google Scholar
• Vernet C, Leu-Semenescu S, Buzare MA, Arnulf I. Subjective symptoms in idiopathic hypersomnia: beyond excessive sleepiness. J Sleep Res. 2010;19(4):525–534. doi:10.1111/j.1365-2869.2010.00824.x
   PubMed Web of Science ®Google Scholar
• Miglis MG, Schneider L, Kim P, Cheung J, Trotti LM. Frequency and severity of autonomic symptoms in idiopathic hypersomnia. J Clin Sleep Med. 2020;16(5):749–756. doi:10.5664/jcsm.8344
   PubMed Web of Science ®Google Scholar
• Bassetti C, Aldrich MS. Idiopathic hypersomnia. A series of 42 patients. Brain. 1997;120(Pt 8):1423–1435. doi:10.1093/brain/120.8.1423
   PubMed Web of Science ®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):1255–1263. doi:10.5664/jcsm.8482
   PubMed Web of Science ®Google Scholar
• Saad R, Ben-Joseph R, Prince P, Stack C, Bujanover S, Taylor B. Utilization of diagnostic sleep testing prior to idiopathic hypersomnia diagnosis among US adults: a real-world claims analysis [poster 499]. Presented at: Annual Meeting of the Associated Professional Sleep Societies; June 10–13; 2021.
   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. doi:10.1016/j.smrv.2022.101709
   PubMed Web of Science ®Google Scholar
• American Academy of Sleep Medicine. Idiopathic hypersomnia with long sleep time. In: International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005:98–103.
   Google Scholar
• Trotti LM, Ong JC, Plante DT, Friederich MC, 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;75:343–349. doi:10.1016/j.sleep.2020.08.034
   PubMed Web of Science ®Google Scholar
• Jazz Pharmaceuticals, Inc. Xywav® (Calcium, Magnesium, Potassium, and Sodium Oxybates) Oral Solution, CIII [Prescribing Information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; 2022.
   Google Scholar
• Jazz Pharmaceuticals announces U.S. FDA approval of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia in adults [press release]; 2021. Available from: http://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-xywavr-calcium. Accessed October 4, 2021.
   Google Scholar
• Szarfman A, Kuchenberg T, Soreth J, Lajmanovich S. Declaring the sodium content of drug products. N Engl J Med. 1995;333(19):1291. doi:10.1056/NEJM199511093331917
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration, Center for Drug Evaluation and Research. Clinical review for Binosto, NDA 202344; 2012. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344Orig1s000MedR.pdf. Accessed February 28, 2023
   Google Scholar
• US Food and Drug Administration, Center for Drug Evaluation and Research. Quantitative labeling of sodium, potassium, and phosphorus for human over-the-counter and prescription drug products [guidance for industry]; 2022. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug. Accessed October 11, 2022
   Google Scholar
• Billiard M, Sonka K. Idiopathic hypersomnia. Sleep Med Rev. 2016;29:23–33. doi:10.1016/j.smrv.2015.08.007
   PubMed Web of Science ®Google Scholar
• Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(9):1881–1893. doi:10.5664/jcsm.9328
   PubMed Web of Science ®Google Scholar
• Johns M, Hocking B. Daytime sleepiness and sleep habits of Australian workers. Sleep. 1997;20(10):844–849. doi:10.1093/sleep/20.10.844
   PubMed Web of Science ®Google Scholar
• Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540–545. doi:10.1093/sleep/14.6.540
   PubMed Web of Science ®Google Scholar
• Dauvilliers Y, Evangelista E, Barateau L, et al. Measurement of symptoms in idiopathic hypersomnia: the Idiopathic Hypersomnia Severity Scale. Neurology. 2019;92(15):e1754–e1762. doi:10.1212/WNL.0000000000007264
   PubMed Web of Science ®Google Scholar
• Rassu AL, Evangelista E, Barateau L, et al. Idiopathic Hypersomnia Severity Scale to better quantify symptoms severity and their consequences in idiopathic hypersomnia. J Clin Sleep Med. 2022;18(2):617–629. doi:10.5664/jcsm.9682
   PubMed Web of Science ®Google Scholar
• Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health. 2005;8(suppl 1):S9–S24. doi:10.1111/j.1524-4733.2005.00066.x
   PubMed Web of Science ®Google Scholar
• Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004;2:12. doi:10.1186/1477-7525-2-12
   PubMedGoogle Scholar
• Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, 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. doi:10.1016/S1474-4422(21)00368-9
   PubMed Web of Science ®Google Scholar
• Mayer G, Benes H, Young P, Bitterlich M, Rodenbeck A. Modafinil in the treatment of idiopathic hypersomnia without long sleep time—a randomized, double-blind, placebo-controlled study. J Sleep Res. 2015;24(1):74–81. doi:10.1111/jsr.12201
   PubMed Web of Science ®Google Scholar
• Nevsimalova S, Susta M, Prihodova I, Maurovich Horvat E, Milata M, Sonka K. Idiopathic hypersomnia: a homogeneous or heterogeneous disease? Sleep Med. 2021;80:86–91. doi:10.1016/j.sleep.2021.01.031
   PubMed Web of Science ®Google Scholar
• Dauvilliers Y, Paquereau J, Bastuji H, Drouot X, Weil JS, Viot-Blanc V. Psychological health in central hypersomnias: the French Harmony study. J Neurol Neurosurg Psychiatry. 2009;80(6):636–641. doi:10.1136/jnnp.2008.161588
   PubMed Web of Science ®Google Scholar
• Neikrug AB, Crawford MR, Ong JC. Behavioral sleep medicine services for hypersomnia disorders: a survey study. Behav Sleep Med. 2017;15(2):158–171. doi:10.1080/15402002.2015.1120201
   PubMed Web of Science ®Google Scholar
• Ali M, Auger RR, Slocumb NL, Morgenthaler TI. Idiopathic hypersomnia: clinical features and response to treatment. J Clin Sleep Med. 2009;5(6):562–568. doi:10.5664/jcsm.27658
   PubMed Web of Science ®Google Scholar
• Schinkelshoek MS, Fronczek R, Lammers GJ. Update on the treatment of idiopathic hypersomnia. Curr Sleep Med Rep. 2019;5(4):207–214. doi:10.1007/s40675-019-00158-7
   Google Scholar