Dosing and transition characteristics in people with narcolepsy transitioning from sodium oxybate to low-sodium oxybate: Data from the real-world TENOR study

Sleep Med. 2024 Jan:113:328-337. doi: 10.1016/j.sleep.2023.11.022. Epub 2023 Nov 25.

Abstract

Objective: The Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR) study assessed the real-world experience of people with narcolepsy switching from sodium oxybate (SXB) to low-sodium oxybate (LXB; 92 % less sodium than SXB).

Methods: TENOR is a patient-centric, prospective, observational, virtual-format study. Eligible participants included US adults with narcolepsy transitioning from SXB to LXB (±7 days from LXB initiation). Longitudinal data were collected from baseline (taking SXB) through 21 weeks post-transition.

Results: TENOR included 85 participants with narcolepsy (type 1, n = 45; type 2, n = 40). Mean (SD) age was 40.3 (13.0) years; the majority (73 %) were female and White (87 %). At study completion, wake-promoting agents were the most common concomitant medications (47 %). Mean (SD) SXB treatment duration was 57.8 (52.1) months; 96 % took SXB twice nightly. After transitioning, 97 % continued on twice-nightly regimens. Mean (SD) dose of both total nightly SXB (n = 85) and baseline LXB (n = 84) was 7.7 (1.5) g; SXB-LXB dose conversions at baseline were gram-for-gram in 87 % of participants. The mean final total nightly dose of LXB was 7.9 g. The most common participant-reported reasons for transitioning included lower sodium content for improved long-term health (93 %), physician recommendation (47 %), to avoid cardiovascular issues (39 %), to avoid side effects (31 %), and to improve control of narcolepsy symptoms (18 %).

Conclusion: Most participants transitioned from SXB to LXB using a gram-for-gram strategy. The most commonly cited reason for transition was long-term health benefits due to lower sodium.

Keywords: Calcium, magnesium, potassium, and sodium oxybates; Long-term health; Low-sodium oxybate; Narcolepsy; Sodium oxybate; Titration.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Female
  • Humans
  • Male
  • Narcolepsy* / diagnosis
  • Prospective Studies
  • Sodium / therapeutic use
  • Sodium Oxybate* / adverse effects
  • Wakefulness-Promoting Agents* / therapeutic use

Substances

  • Sodium
  • Sodium Oxybate
  • Wakefulness-Promoting Agents