Evidence map›Paper›PMID 35633275›Full record

Trial reportHuman psychopharmacology2022

Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea.

Frederick Vinckenbosch, Jerryll Asin, Nicolaas de Vries, Patty E Vonk, Claire E H M Donjacour, Gert Jan Lammers, Sebastiaan Overeem, Hennie Janssen, Grace Wang, Dan Chen and 4 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human psychopharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
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  6. Review
  7. Review
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

14 authors at 8 institutions in 4 countries.

Frederick VinckenboschFaculty of Psychology and Neuroscience, Maastricht University, Maastricht, Netherlands.ORCID 0000-0002-1767-7742
Jerryll AsinCenter for Sleep Medicine Amphia, Breda, Netherlands.
Nicolaas de VriesFaculty of Medicine and Health Sciences, Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.
Patty E VonkOLVG, Amsterdam, Netherlands.
Claire E H M DonjacourSleep-Wake Centre SEIN, Netherlands.
Gert Jan LammersSleep-Wake Centre SEIN, Netherlands.
Sebastiaan OvereemSleep Medicine Center Kempenhaeghe, Heeze, Netherlands.
Hennie JanssenSleep Medicine Center Kempenhaeghe, Heeze, Netherlands.
Grace WangJazz Pharmaceuticals, Palo Alto, California, USA.
Dan ChenJazz Pharmaceuticals, Palo Alto, California, USA.
Lawrence P CarterAlexza Pharmaceuticals, Inc, Mountain View, California, USA.
Kefei ZhouJazz Pharmaceuticals, Palo Alto, California, USA.
Annemiek VermeerenFaculty of Psychology and Neuroscience, Maastricht University, Maastricht, Netherlands.
Johannes G RamaekersFaculty of Psychology and Neuroscience, Maastricht University, Maastricht, Netherlands.
Jazz Pharmaceuticals (United States) · USMaastricht University · NLKempenhaeghe · NLAmphia Ziekenhuis · NLAntwerp University Hospital · BEJazz Pharmaceuticals (Italy) · ITLeiden University Medical Center · NLOLVG · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA).

methodsEligible participants were aged 21-75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency <30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days]) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on-road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint.

resultsSolriamfetol significantly reduced SDLP at 2 (n = 34; least squares mean difference, -1.1 cm; 95% CI, -1.85, -0.32; p = 0.006) and 6 hours postdose (n = 32; least squares mean difference, -0.8 cm; 95% CI, -1.58, -0.03; p = 0.043). Two hours postdose, 4 placebo-treated and 1 solriamfetol-treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment-emergent adverse events included headache, nausea, and insomnia.

conclusionsSolriamfetol 300 mg/day significantly improved on-the-road driving performance in participants with EDS associated with OSA.

Indexed as

Disorders of Excessive SomnolenceSleep Apnea, ObstructiveCarbamatesHumansPhenylalanineCarbamatesPhenylalaninesolriamfetolexcessive daytime sleepinessobstructive sleep apnoeaon-the-road drivingsolriamfetolSunosi

Identifiers

PMID35633275
PMCPMC9788130
OpenAlexW4281763983

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.