0766 Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People with Narcolepsy: Final Results from REFRESH

Abstract Introduction Oxybate treatment improves quality of life (QOL) for people with narcolepsy; however, the middle-of-the-night dose required with twice-nightly oxybates (TN-OXB) can be burdensome. Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is approved to treat cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. REFRESH (NCT06792708) is a prospective, real-world study that assessed ON-SXB treatment for narcolepsy. Methods Adults with narcolepsy who switched from current TN-OXB (switch participants), or had prior TN-OXB use or were oxybate-naive (not-oxybate-treated) received ON-SXB titrated in 1.5-g increments weekly or more gradually, based on efficacy/tolerability, up to 9 g/night. At baseline and end of study (EOS), all participants completed a 7-question survey about their QOL and narcolepsy symptoms. Switch participants completed a baseline survey about their TN-OXB treatment experience. All participants completed an EOS questionnaire about their ON-SXB treatment experience. Results In total, 71 participants initiated ON-SXB (switch, n=25 [35%]; prior TN-OXB use, n=10 [14%]; oxybate-naive, n=36 [51%]). Mean (SD) QOL (0=“worst possible,” 10=“best possible”) was 5.9 (1.3) and 5.2 (1.5) at baseline to 7.6 (1.4) and 6.9 (1.4) at EOS for switch (n=20) and not-oxybate-treated (n=34) participants, respectively. Mean (SD) fatigue (0=“never fatigued,” 10=“extremely fatigued”) was 6.3 (1.7) and 8.0 (1.6) at baseline to 4.3 (2.3) and 5.1 (2.1) at EOS for switch (n=20) and not-oxybate-treated (n=34) participants, respectively. Most switch participants (92% [23/25]) found the second TN-OXB dose burdensome. At EOS (n=54), narcolepsy was “somewhat” or “much” better with ON-SXB (switch, 70%; not-oxybate-treated, 91%). Participants reported not falling asleep during the day (switch, 55%; not-oxybate-treated, 68%), sleeping through the night (switch, 65%; not-oxybate-treated, 85%), getting more done at work/school (switch, 40%; not-oxybate-treated, 62%), improved socialization (switch, 55%; not-oxybate-treated, 71%), and less drowsy driving among those who had previously experienced drowsy driving (switch, 100% [8/8]; not-oxybate-treated, 90% [19/21]). 75% (15/20) of switch participants preferred ON-SXB to TN-OXB; 10% were not sure or had no opinion. 80% (16/20) of switch participants reported better adherence to once-nightly dosing. Conclusion These real-world data demonstrate that ON-SXB treatment improved narcolepsy symptoms and QOL for both switch and not-oxybate-treated patients. The majority of switch participants preferred ON-SXB to TN-OXB. Support (if any) Avadel Pharmaceuticals

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Journal
SLEEP
Published
2026-05-01
DOI
https://doi.org/10.1093/sleep/zsag091.0765
Primary Topic
Sleep and Wakefulness Research
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article
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article

0766 Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People with Narcolepsy: Final Results from REFRESH

RICHARD BOGAN, Jennifer Gudeman, Adrian Santamaria, J. P. McConnell et al.
SLEEP
Sleep and Wakefulness Research
article

0766 Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People with Narcolepsy: Final Results from REFRESH

RICHARD BOGAN, Jennifer Gudeman, Adrian Santamaria, J. P. McConnell, Oktai Mamedov, Robyn Porpiglio, Sarah Meskill, Matthew Davis, Gerard Meskill, Sally Ibrahim, Laura Herpel, Asim Roy, Gretchen Richards, Omavi Bailey, Brian Abaluck
article en

Abstract

Abstract Introduction Oxybate treatment improves quality of life (QOL) for people with narcolepsy; however, the middle-of-the-night dose required with twice-nightly oxybates (TN-OXB) can be burdensome. Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is approved to treat cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. REFRESH (NCT06792708) is a prospective, real-world study that assessed ON-SXB treatment for narcolepsy. Methods Adults with narcolepsy who switched from current TN-OXB (switch participants), or had prior TN-OXB use or were oxybate-naive (not-oxybate-treated) received ON-SXB titrated in 1.5-g increments weekly or more gradually, based on efficacy/tolerability, up to 9 g/night. At baseline and end of study (EOS), all participants completed a 7-question survey about their QOL and narcolepsy symptoms. Switch participants completed a baseline survey about their TN-OXB treatment experience. All participants completed an EOS questionnaire about their ON-SXB treatment experience. Results In total, 71 participants initiated ON-SXB (switch, n=25 [35%]; prior TN-OXB use, n=10 [14%]; oxybate-naive, n=36 [51%]). Mean (SD) QOL (0=“worst possible,” 10=“best possible”) was 5.9 (1.3) and 5.2 (1.5) at baseline to 7.6 (1.4) and 6.9 (1.4) at EOS for switch (n=20) and not-oxybate-treated (n=34) participants, respectively. Mean (SD) fatigue (0=“never fatigued,” 10=“extremely fatigued”) was 6.3 (1.7) and 8.0 (1.6) at baseline to 4.3 (2.3) and 5.1 (2.1) at EOS for switch (n=20) and not-oxybate-treated (n=34) participants, respectively. Most switch participants (92% [23/25]) found the second TN-OXB dose burdensome. At EOS (n=54), narcolepsy was “somewhat” or “much” better with ON-SXB (switch, 70%; not-oxybate-treated, 91%). Participants reported not falling asleep during the day (switch, 55%; not-oxybate-treated, 68%), sleeping through the night (switch, 65%; not-oxybate-treated, 85%), getting more done at work/school (switch, 40%; not-oxybate-treated, 62%), improved socialization (switch, 55%; not-oxybate-treated, 71%), and less drowsy driving among those who had previously experienced drowsy driving (switch, 100% [8/8]; not-oxybate-treated, 90% [19/21]). 75% (15/20) of switch participants preferred ON-SXB to TN-OXB; 10% were not sure or had no opinion. 80% (16/20) of switch participants reported better adherence to once-nightly dosing. Conclusion These real-world data demonstrate that ON-SXB treatment improved narcolepsy symptoms and QOL for both switch and not-oxybate-treated patients. The majority of switch participants preferred ON-SXB to TN-OXB. Support (if any) Avadel Pharmaceuticals

SLEEPVol. 49(Supplement_1)
Heart Rhythm Society (US), University of South Carolina (US), University Hospitals of Cleveland (US), Endocrinology Northwest (US), Cleveland Sleep Research Center (US), Patients First (US), Sleep Management Institute (US), Avanir Pharmaceuticals (United States) (US), SleepMed (US)
Openalex Percentile: Top 8%
Sleep and Wakefulness Research
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