Trial reportChest2019
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Trial report in Chest, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 2 of them syntheses that pooled 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.
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 Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)
A Double-Blind, Randomized, Placebo-Controlled, Single-Center, Flexible Titration Study Evaluating the Efficacy of Solriamfetol in Treating Fatigue and Cognitive Symptoms in Adults Aged 18-65 Years With a Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.
- Pooled it
- European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea.European respiratory review : an official journal of the European Respiratory Society · 2021Guideline
- 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
- Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial.American journal of respiratory and critical care medicine · 2020Trial
- Trial
- Methodological considerations for analyzing enriched enrolment randomized withdrawal trials.Clinics (Sao Paulo, Brazil) · 2026Article
- The Role of Pharmacotherapy for Excessive Daytime Sleepiness in OSA: A Changing Landscape?CHEST pulmonary · 2026Review
- Advances in Non-CPAP Management of Obstructive Sleep Apnea: Spotlight on Pharmacological Therapies.Journal of personalized medicine · 2026Review
- Real-world effectiveness and tolerability of wake-promoting agents for residual sleepiness in treated obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026Article
- Impact of solriamfetol treatment on sleep quality in Chinese patients with OSA-EDS: results of a randomized controlled trial.Frontiers in medicine · 2026Article
- 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
- Excessive daytime sleepiness in young and middle-aged Chinese adults with obstructive sleep apnea: implications for cognitive dysfunction.Sleep & breathing = Schlaf & Atmung · 2024Article
- Pharmacological interventions for the treatment of obstructive sleep apnea syndrome.Frontiers in medicine · 2024Article
- Recommendations for clinical management of excessive daytime sleepiness in obstructive sleep apnoea - A Delphi consensus study.Sleep medicine · 2023Review
- Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea.CNS drugs · 2023Review
- Article
- Asymmetric Synthesis of US-FDA Approved Drugs over Five Years (2016-2020): A Recapitulation of Chirality.Pharmaceuticals (Basel, Switzerland) · 2023Review
Corrections and comments
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Authors and funding
12 authors at 11 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExcessive sleepiness (ES) is a common symptom of OSA, which often persists despite primary OSA therapy. This phase III randomized withdrawal trial evaluated solriamfetol (JZP-110) for the treatment of ES in adults with OSA.
methodsAfter 2 weeks of clinical titration (n = 174) and 2 weeks of stable dose administration (n = 148), participants who reported improvement on the Patient Global Impression of Change (PGI-C) and had numerical improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) were randomly assigned to placebo (n = 62) or solriamfetol (n = 62) for 2 additional weeks. Coprimary end points were change from weeks 4 to 6 in MWT and ESS.
resultsIn the modified intention-to-treat population (n = 122), MWT mean sleep latencies and ESS scores improved from baseline to week 4 (from 12.3-13.1 to 29.0-31.7 minutes and from 15.3-16.0 to 5.9-6.4, respectively). From weeks 4 to 6, participants treated with solriamfetol maintained improvements (least squares [LS] mean [SE] changes of -1.0 [1.4] minutes on MWT and -0.1 [0.7] on ESS), whereas participants treated with placebo worsened (LS mean [SE] change of -12.1 [1.3] minutes on MWT and 4.5 [0.7] on ESS); LS mean differences between treatments were 11.2 minutes (95% CI, 7.8-14.6) and -4.6 (95% CI, -6.4 to -2.8) on MWT and ESS, respectively. Fewer participants treated with solriamfetol reported worsening on the PGI-C from weeks 4 to 6 (20% vs 50%; P = .0005). Common adverse events included headache, dry mouth, nausea, dizziness, and insomnia.
conclusionsThis study demonstrated maintenance of solriamfetol efficacy and safety over 6 weeks. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02348619; URL: www.clinicaltrials.gov; EudraCT No.: 2014-005515-16.
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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.