RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates.

ABSTRACT:

Objective/background

Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE (NCT04451668).

Patients/methods

Participants aged ≥16 years with narcolepsy who completed the phase 3 REST-ON trial, were oxybate-naive, or were on a stable IR oxybate dose (≥1 month) were eligible for RESTORE. For participants who switched from twice-nightly dosing to ON-SXB, initial doses were closest or equivalent to their previous nightly IR oxybate dose. These participants completed a questionnaire at baseline about nocturnal adverse events associated with the middle-of-the-night IR oxybate dose in the preceding 3 months, a

SUBMITTER: Roy A 

PROVIDER: S-EPMC11388664 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature