Evidence map›Paper›PMID 37246913›Full record

Trial reportSleep2023

Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial.

Yves Dauvilliers, Thomas Roth, Richard Bogan, Michael J Thorpy, Anne Marie Morse, Asim Roy, Jordan Dubow, Jennifer Gudeman

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Optimizing patient outcomes and empowering the patient-clinician partnership.Sleep advances : a journal of the Sleep Research Society · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Narcolepsy and rapid eye movement sleep.Journal of sleep research · 2025
    Review
  7. Review
  8. Review
  9. Article
  10. Recommended protocols for the Multiple Sleep Latency Test and Maintenance of Wakefulness Test in children: guidance from the American Academy of Sleep Medicine.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 2 countries.

Yves DauvilliersDepartment of Neurology, Sleep-Wake Disorders Center, Gui-de-Chauliac Hospital, Institute for Neurosciences of Montpellier INM, INSERM, University of Montpellier, Montpellier, France.ORCID 0000-0003-0683-6506
Thomas RothSleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.
Richard BoganUniversity of South Carolina School of Medicine, Columbia, SC, USA.ORCID 0000-0001-7043-2974
Michael J ThorpyMontefiore Medical Center, New York, NY, USA.
Anne Marie MorseGeisinger Commonwealth School of Medicine, Geisinger Medical Center, Janet Weis Children's Hospital, Danville, PA, USA.ORCID 0000-0003-4494-0195
Asim RoyOhio Sleep Medicine Institute, Dublin, OH, USA.
Jordan DubowAvadel Pharmaceuticals, Chesterfield, MO, USA.
Jennifer GudemanAvadel Pharmaceuticals, Chesterfield, MO, USA.ORCID 0000-0002-7375-5020
Geisinger Medical Center · USHenry Ford Health System · USInserm · FRMedical University of South Carolina · USMontefiore Medical Center · USSleep Management Institute · US

Funding

Avadel Pharmaceuticals
6 · The paper itself

Abstract

STUDY

objectivesPost hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1) and 2 (NT2).

methodsParticipants were stratified by narcolepsy type and randomized 1:1 to ON-SXB (4.5 g, week 1; 6 g, weeks 2-3; 7.5 g, weeks 4-8; and 9 g, weeks 9-13) or placebo. Assessments included mean sleep latency on Maintenance of Wakefulness Test (MWT) and Clinical Global Impression-Improvement (CGI-I) rating (coprimary endpoints) and sleep stage shifts, nocturnal arousals, and patient-reported sleep quality, refreshing nature of sleep, and Epworth Sleepiness Scale (ESS) score (secondary endpoints) separately in NT1 and NT2 subgroups.

resultsThe modified intent-to-treat population comprised 190 participants (NT1, n = 145; NT2, n = 45). Significant improvements were demonstrated with ON-SXB vs placebo in sleep latency for NT1 (all doses, p < .001) and NT2 (6 and 9 g, p < .05) subgroups. Greater proportions of participants in both subgroups had CGI-I ratings of much/very much improved with ON-SXB vs placebo. Sleep stage shifts and sleep quality significantly improved in both subgroups (all doses vs placebo, p < .001). Significant improvements with all ON-SXB doses vs placebo in refreshing nature of sleep (p < .001), nocturnal arousals (p < .05), and ESS scores (p ≤ .001) were reported for NT1 with directional improvements for NT2.

conclusionsClinically meaningful improvements of a single ON-SXB bedtime dose were shown for daytime sleepiness and DNS in NT1 and NT2, with less power for the limited NT2 subgroup.

Indexed as

Disorders of Excessive SomnolenceNarcolepsySodium OxybateHumansSleepTreatment OutcomeWakefulnessSodium Oxybateextended releasenarcolepsynarcolepsy type 1narcolepsy type 2once-nightly dosing; sodium oxybate; randomized controlled trial

Identifiers

PMID37246913
PMCPMC10636255
OpenAlexW4378640206

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.