CONSISTENT EFFICACY OF ONCE-NIGHTLY SODIUM OXYBATE ON DISRUPTED NIGHTTIME SLEEP IN PEOPLE WITH NARCOLEPSY

Document Type

Conference Proceeding

Publication Date

5-19-2025

Publication Title

Sleep

Abstract

Introduction: Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) demonstrated efficacy in treating narcolepsy symptoms, including disrupted nighttime sleep (DNS), in the phase 3 REST-ON trial (NCT02720744). This post hoc analysis assessed ON-SXB efficacy on DNS across various participant subgroups. Methods: Participants aged ≥16 years with narcolepsy type 1 (NT1) or 2 (NT2) were randomized 1:1 to ON-SXB (week 1, 4.5 g; weeks 2-3, 6 g; weeks 4-8, 7.5 g; weeks 9-13, 9 g) or pla cebo. Least squares mean differences (LSMDs) in changes from baseline for ON-SXB vs placebo for number of sleep stage shifts and nocturnal arousals as measured by polysomnography, as well as patient-reported sleep quality and refreshing nature of sleep, were compared among demographic (age, sex, race, body mass index [BMI] category), narcolepsy type (NT1/NT2), and concomitant alerting agent use subgroups from the modified intent-to-treat population (mITT;≥1 efficacy measurement after receiving the 6-g dose). Results: In the mITT population (ON-SXB, n=97; placebo, n=93), LSMDs for ON-SXB vs placebo demonstrated significant improvements from baseline (P< 0.001) in number of sleep stage shifts at week 13 (9 g) across all participant subgroups, including age (< 35, ≥35 years), sex (female, male), race (white, non-white), BMI (low [< 25 kg/m2], high [≥25 kg/m2]), narcolepsy type (NT1, NT2), and alerting agent/no alerting agent use. LSMDs were sig nificant in favor of ON-SXB 9 g vs placebo for change from base line in number of nocturnal arousals (P< 0.05) in all subgroups, except age ≥35 years. At week 13, ON-SXB was associated with significant improvement from baseline (P< 0.05) in visual ana logue scale (VAS) sleep quality compared with placebo across all subgroups, except non-white. All subgroups exhibited significant improvements (P≤0.01) in VAS refreshing nature of sleep with ON-SXB 9 g vs placebo, except NT2. Comparable trends were observed with the 6-g dose at week 3 and the 7.5-g dose at week 8. Conclusion: While the trial was not powered to test for subgroup differences, these post hoc analyses demonstrate the robust, con sistent efficacy of ON-SXB in treating DNS, including reducing nocturnal arousals and increasing refreshing nature of sleep, in patients with narcolepsy across various demographic and clini cal characteristics.

Volume

48

First Page

A362

Last Page

A363

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