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Patients with narcolepsy overwhelmingly preferred once-nightly extended-release sodium oxybate (ON-SXB) over twice-nightly immediate-release (IR) oxybate. ON-SXB simplifies dosing, reducing treatment burdens and improving adherence for narcolepsy management.

Keywords:
AdherenceNarcolepsyNocturnal adverse eventsOnce-nightlySodium oxybateTwice-nightly

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Area of Science:

  • Pharmacology
  • Neurology
  • Sleep Medicine

Background:

  • Narcolepsy treatment often involves sodium oxybate, typically administered in multiple daily doses.
  • Immediate-release (IR) oxybate requires a middle-of-the-night (MON) dose, posing challenges for adherence and patient experience.
  • Extended-release formulations aim to improve treatment convenience and patient outcomes.

Purpose of the Study:

  • To assess patient preference for once-nightly extended-release sodium oxybate (ON-SXB) compared to twice-nightly immediate-release (IR) oxybate.
  • To evaluate the treatment burden and adherence associated with the middle-of-the-night (MON) dose of IR oxybate.
  • To determine patient satisfaction with a simplified ON-SXB dosing regimen.

Main Methods:

  • An open-label, switch study (RESTORE) enrolled participants with narcolepsy switching from IR oxybate to ON-SXB.
  • Participants completed questionnaires assessing adverse events with MON IR oxybate, preference between formulations, and adherence.
  • Dosing of ON-SXB was initiated based on the previous IR oxybate regimen.

Main Results:

  • Of 130 switching participants, 93.9% preferred ON-SXB over twice-nightly IR oxybate.
  • At baseline, 69.2% missed their second IR oxybate dose, leading to worsened next-day symptoms in 80%.
  • Significant burdens included grogginess (51% of those taking a late second dose), falls (8%), and injuries (4%) associated with the MON IR oxybate dose.

Conclusions:

  • The middle-of-the-night (MON) dose of immediate-release (IR) oxybate presents substantial treatment burdens and adherence issues.
  • Patients strongly preferred the simplified, once-nightly dosing schedule of extended-release sodium oxybate (ON-SXB).
  • ON-SXB offers a more convenient and potentially safer alternative for narcolepsy management.