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ORIGINAL RESEARCH

Individualized Treatment Patterns for Patients with Narcolepsy Treated with Oxybate: A Clinical Practice Perspective

, ORCID Icon, , ORCID Icon, &
Pages 767-778 | Received 10 Mar 2023, Accepted 08 Aug 2023, Published online: 29 Sep 2023

References

  • Thorpy MJ, Dauvilliers Y. Clinical and practical considerations in the pharmacologic management of narcolepsy. Sleep Med. 2015;16(1):9–18. doi:10.1016/j.sleep.2014.10.002
  • Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007;369(9560):499–511. doi:10.1016/S0140-6736(07)60237-2
  • Thorpy MJ, Hiller G. The medical and economic burden of narcolepsy: implications for managed care. Am Health Drug Benefits. 2017;10(5):233–241.
  • Narcolepsy fact sheet; 2017. Available from: https://catalog.ninds.nih.gov/pubstatic/17-1637/17-1637.pdf. Accessed January 16, 2019.
  • Morgenthaler TI, Kapur VK, Brown T, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep. 2007;30(12):1705–1711. doi:10.1093/sleep/30.12.1705
  • 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
  • Mignot EJ. A practical guide to the therapy of narcolepsy and hypersomnia syndromes. Neurotherapeutics. 2012;9(4):739–752. doi:10.1007/s13311-012-0150-9
  • Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. J Sleep Res. 2021;30:e13387. doi:10.1111/jsr.13387
  • Turner K, Zambrelli E, Lavolpe S, Baldi C, Furia F, Canevini MP. Obstructive sleep apnea: neurocognitive and behavioral functions before and after treatment. Funct Neurol. 2019;34(2):71–78.
  • Pellitteri G, de Biase S, Valente M, Gigli GL. How treatable is narcolepsy with current pharmacotherapy and what does the future hold? Expert Opin Pharmacother. 2021;22(12):1517–1520. doi:10.1080/14656566.2021.1915987
  • Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006;29(7):939–946. doi:10.1093/sleep/29.7.939
  • Plazzi G, Ruoff C, Lecendreux M, et al. Treatment of paediatric narcolepsy with sodium oxybate: a double-blind, placebo-controlled, randomised-withdrawal multicentre study and open-label investigation. Lancet Child Adolesc Health. 2018;2(7):483–494. doi:10.1016/S2352-4642(18)30133-0
  • U.S. Xyrem Multicenter Study Group. A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25(1):42–49.
  • U.S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004;5(2):119–123. doi:10.1016/j.sleep.2003.11.002
  • Xyrem International Study Group. A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 2005;1(4):391–397. doi:10.5664/jcsm.26368
  • Bogan RK, Thorpy MJ, Dauvilliers Y, et al. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Sleep. 2021;44(3):zsaa206. doi:10.1093/sleep/zsaa206
  • Jazz Pharmaceuticals. Xyrem® (Sodium Oxybate) Oral Solution, CIII [Prescribing Information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; 2023.
  • Jazz Pharmaceuticals. Xywav® (Calcium, Magnesium, Potassium, and Sodium Oxybates) Oral Solution, CIII [Prescribing Information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; 2023.
  • 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
  • US Food and Drug Administration. 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.
  • US Food and Drug Administration. Clinical review for Binosto, NDA 202344; 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344Orig1s000MedR.pdf. Accessed February 28, 2023.
  • Roth T, Dauvilliers Y, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate on disrupted nighttime sleep in patients with narcolepsy. J Sleep Res. 2017;26(4):407–414. doi:10.1111/jsr.12468
  • Schinkelshoek MS, Smolders IM, Donjacour CE, et al. Decreased body mass index during treatment with sodium oxybate in narcolepsy type 1. J Sleep Res. 2019;28(3):e12684. doi:10.1111/jsr.12684
  • Linn AJ, van Dijk L, van Weert JCM, Gebeyehu BG, van Bodegraven AA, Smit EG. Creating a synergy effect: a cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes. Patient Educ Couns. 2018;101(8):1419–1426. doi:10.1016/j.pec.2018.03.017
  • Violette PD, Agoritsas T, Alexander P, et al. Decision aids for localized prostate cancer treatment choice: systematic review and meta-analysis. CA Cancer J Clin. 2015;65(3):239–251. doi:10.3322/caac.21272
  • Wilson SR, Strub P, Buist AS, et al. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med. 2010;181(6):566–577. doi:10.1164/rccm.200906-0907OC
  • Drakatos P, Lykouras D, D’Ancona G, et al. Safety and efficacy of long-term use of sodium oxybate for narcolepsy with cataplexy in routine clinical practice. Sleep Med. 2017;35:80–84. doi:10.1016/j.sleep.2017.03.028
  • Mayer G, Plazzi G, Iranzo A, et al. Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study. Sleep. 2018;41(9). doi:10.1093/sleep/zsy128
  • Ohayon MM, Thorpy MJ, Short SA, et al. Sodium oxybate dosing utilization patterns in the Nexus Narcolepsy Registry [abstract 0605]. Sleep. 2019;42(suppl 1):A241. doi:10.1093/sleep/zsz067.603
  • Peraita-Adrados R, Bellón JM, Lillo-Triguero L, López-Esteban P, Medrano-Martínez P. Long-term follow-up on the effects of sodium oxybate on daytime sleepiness and sleep architecture in patients with narcolepsy type 1. Rev Neurol. 2023;76(2):35–40. doi:10.33588/rn.7602.2022315
  • Roy A, Profant J, Morris S, et al. Sodium oxybate prescribing adjustments by physicians in a real world clinical setting [abstract]. Sleep Med. 2019;64(suppl 1):S329–S330. doi:10.1016/j.sleep.2019.11.921
  • UCB Pharma. Xyrem [Summary of Product Characteristics]. Brussels, Belgium: UCB Pharma; 2022.
  • Avadel CNS Pharmaceuticals. LumryzTM (Sodium Oxybate) for Extended-Release Oral Solution, CIII [Prescribing Information]. Chesterfield, MO: Avadel CNS Pharmaceuticals; 2023.
  • Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension as the First and Only Once-at-Bedtime Oxybate for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy [press release]; 2023. Available from: https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-final-fda-approval-lumryztm. Accessed May 1, 2023.
  • Clinical superiority findings; 2021. Available from: https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings. Accessed July 9, 2021.