Trial reportSleep2020
Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.
Trial report in Sleep, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02348632 (A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [), which is not on this map. Cited by 38 papers.
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.
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.
A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea
Who cites it
38 citing papers in PubMed, 249 citations in OpenAlex.
- Trial
- The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial.American journal of respiratory and critical care medicine · 2023Trial
- Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial.Human psychopharmacology · 2023Trial
- Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea.Human psychopharmacology · 2022Trial
- Test-retest reliability of the Epworth Sleepiness Scale in clinical trial settings.Journal of sleep research · 2022Trial
- Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022Trial
- Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021Trial
- A Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Study of the Effects of Solriamfetol on QTcF Intervals in Healthy Participants.Clinical pharmacology in drug development · 2021Trial
- An updated systematic review and meta-analysis of modafinil for excessive daytime sleepiness in narcolepsy.Sleep medicine: X · 2026Review
- Pharmacological and non-pharmacological methods of inducing wakefulness activate distinct neural populations in the mouse brain.PLoS biology · 2026Article
- Impact of solriamfetol treatment on sleep quality in Chinese patients with OSA-EDS: results of a randomized controlled trial.Frontiers in medicine · 2026Article
- A Comprehensive Review of Current and Emerging Treatments for Narcolepsy Type 1.Journal of clinical medicine · 2025Review
- Subjective daytime sleepiness, not sleep quality or hypoxia, predicts sleep-dependent memory consolidation in a cohort of older adults.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025Article
- Patients with obstructive sleep apnea in Germany.Sleep & breathing = Schlaf & Atmung · 2025Article
- Article
- The Impact of Probiotic Supplementation on the Sleep Quality of Humans: A Review of Results of Randomized, Blinded, Controlled Studies.Current pharmaceutical design · 2025Review
- RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates.Sleep medicine: X · 2024Article
- Comparative efficacy, safety and benefit/risk of alerting agents for excessive daytime sleepiness in patients with obstructive sleep apnoea: a network meta-analysis.EClinicalMedicine · 2024Article
- Tackling obstructive sleep apnea with pharmacotherapeutics: expert guidance.Expert opinion on pharmacotherapy · 2024Review
- The Changed Nocturnal Sleep Structure and Higher Anxiety, Depression, and Fatigue in Patients with Narcolepsy Type 1.Nature and science of sleep · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 11 institutions in 5 countries.
Funding
Abstract
STUDY
objectivesTo evaluate long-term safety and maintenance of efficacy of solriamfetol treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA).
methodsParticipants with narcolepsy or OSA who completed a prior solriamfetol study were eligible. A 2-week titration period was followed by a maintenance phase (up to 50 weeks). Efficacy was assessed by Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively). After approximately 6 months of treatment, a subgroup entered a 2-week placebo-controlled randomized withdrawal (RW) phase. Change in ESS from beginning to end of the RW phase was the primary endpoint; PGI-C and CGI-C were secondary endpoints. Safety was assessed throughout the study.
resultsIn the maintenance phase, solriamfetol-treated participants demonstrated clinically meaningful improvements on ESS, PGI-C, and CGI-C. In the RW phase, least squares mean change on ESS was 1.6 in participants continuing solriamfetol versus 5.3 in participants switched to placebo (p < .0001). For both secondary endpoints, higher percentages of participants receiving placebo were reported as worse at the end of the RW phase versus solriamfetol (p < .0001). Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants experienced at least one serious TEAE, and 61 (9.5%) withdrew because of TEAEs.
conclusionsThis study demonstrated long-term maintenance of efficacy of solriamfetol under open-label and double-blind, placebo-controlled conditions. Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified.
trial registrationNCT02348632.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.