Evidence map›Paper›PMID 26039969›Full record

Trial reportSleep2015

On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers.

Annemiek Vermeeren, Hong Sun, Eric F P M Vuurman, Stefan Jongen, Cees J Van Leeuwen, Anita C M Van Oers, John Palcza, Xiadong Li, Tine Laethem, Ingeborg Heirman and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01311882 (A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 4% 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.

NCT01311882 phase1completednot on this map

A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2011Enrolled28ConditionsInsomniaArmsMK-4305 40 mg, MK-4305 20 mg, Zopiclone, Grossly Matching Placebo for Zopiclone, Matching Placebo for MK-4305
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Guideline
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  10. Distinct effects of orexin receptor antagonist and GABAProceedings of the National Academy of Sciences of the United States of America · 2019
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  13. Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2016
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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 3 institutions in 3 countries.

Annemiek VermeerenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Hong SunMerck & Co., Inc., Kenilworth, NJ.
Eric F P M VuurmanDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Stefan JongenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Cees J Van LeeuwenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Anita C M Van OersDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
John PalczaMerck & Co., Inc., Kenilworth, NJ.
Xiadong LiMerck & Co., Inc., Kenilworth, NJ.
Tine LaethemMSD Belgium, Brussels, Belgium.
Ingeborg HeirmanMSD Belgium, Brussels, Belgium.
An BautmansMSD Belgium, Brussels, Belgium.
Matthew D TroyerMerck & Co., Inc., Kenilworth, NJ.
Rebecca WrishkoMerck & Co., Inc., Kenilworth, NJ.
Jacqueline McCreaMerck & Co., Inc., Kenilworth, NJ.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMaastricht University · NLMSD (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectiveTo evaluate next-morning driving performance in adults younger than 65 years, after single and repeated doses of suvorexant 20 and 40 mg.

designDouble-blind, placebo-controlled, 4-period crossover study.

settingMaastricht University, The Netherlands.

participants28 healthy volunteers (15 females), aged 23 to 64 years.

interventionsSuvorexant (20 and 40 mg) for 8 consecutive nights; zopiclone 7.5 mg nightly on day 1 and 8; placebo. MEASUREMENTS: Performance on day 2 and 9 (9 h after dosing) using a one-hour standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug-placebo changes in SDLP > 2.4 cm were considered to reflect meaningful driving impairment.

resultsMean drug-placebo changes in SDLP following suvorexant 20 and 40 mg were 1.01 and 1.66 cm on day 2, and 0.48 and 1.31 cm on Day 9, respectively. The 90% CIs of these changes were all below 2.4 cm. Symmetry analysis showed that more subjects had SDLP changes > 2.4 cm than < -2.4 cm following suvorexant 20 and 40 mg on day 2, and following suvorexant 40 mg on day 9. Four female subjects requested that a total of 5 driving tests--all following suvorexant--stop prematurely due to self-reported somnolence.

conclusionsAs assessed by mean changes in standard deviation of lateral position (SDLP), there was no clinically meaningful residual effect of suvorexant in doses of 20 and 40 mg on next-morning driving (9 h after bedtime dosing) in healthy subjects < 65 years old. There may be some individuals who experience next-day effects, as suggested by individual changes in SDLP and prematurely stopped tests. CLINICAL

trial registrationclinicaltrials.gov NCT01311882.

Indexed as

Healthy VolunteersAdultAutomobile DrivingAzabicyclo CompoundsAzepinesCross-Over StudiesDouble-Blind MethodFemaleHumansIndividualityMaleMiddle AgedNetherlandsPiperazinesPsychomotor PerformanceSelf ReportAzabicyclo CompoundsAzepinesPiperazinesSleep Aids, PharmaceuticalsuvorexantTriazoleszopiclonebalancedrivingDSSThypnoticsmemoryorexin antagonistplasma concentrationssuvorexantzopiclone

Identifiers

PMID26039969
PMCPMC4813357
OpenAlexW2210115974

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.