Evidence map›Paper›PMID 27424295›Full record

Trial reportPsychopharmacology2016

On-the-road driving performance the morning after bedtime use of suvorexant 15 and 30 mg in healthy elderly.

Annemiek Vermeeren, Eva Vets, Eric F P M Vuurman, Anita C M Van Oers, Stefan Jongen, Tine Laethem, Ingeborg Heirman, An Bautmans, John Palcza, Xiadong Li and 4 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
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  7. 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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  9. 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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  12. Review
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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.

Annemiek VermeerenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands. a.vermeeren@maastrichtuniversity.nl.
Eva VetsSGS Life Science Services, Antwerp, Belgium.
Eric F P M VuurmanDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.
Anita C M Van OersDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.
Stefan JongenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.
Tine LaethemMerck Translational Medicine Europe, MSD Europe Inc., Brussels, Belgium.
Ingeborg HeirmanMerck Translational Medicine Europe, MSD Europe Inc., Brussels, Belgium.
An BautmansMerck Translational Medicine Europe, MSD Europe Inc., Brussels, Belgium.
John PalczaMerck & Co., Inc., Kenilworth, NJ, USA.
Xiadong LiMerck & Co., Inc., Kenilworth, NJ, USA.
Matthew D TroyerMerck & Co., Inc., Kenilworth, NJ, USA.
Rebecca WrishkoMerck & Co., Inc., Kenilworth, NJ, USA.
Jacqueline McCreaMerck & Co., Inc., Kenilworth, NJ, USA.
Hong SunMerck & Co., Inc., Kenilworth, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleSuvorexant is a first-in-class orexin receptor antagonist for treating insomnia. There is a general concern that hypnotics may impair next-morning driving ability.

objectiveThe objective of this study was to evaluate next-morning driving performance in older adults after single and repeated doses of suvorexant.

methodsDouble-blind, randomized, placebo-controlled, 4-period crossover study in 24 healthy volunteers (10 females), aged 65-80 years. Subjects were treated with suvorexant (15 and 30 mg) for eight consecutive nights, zopiclone 7.5 mg nightly on days 1 and 8, and placebo. Driving performance was assessed on days 2 and 9 (9 h after dosing) using a 1-h standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug-placebo differences in SDLP >2.4 cm were considered to reflect clinically meaningful driving impairment.

resultsDriving performance as measured by SDLP was not impaired following suvorexant. Mean drug-placebo differences in SDLP following suvorexant 15 and 30 mg on day 2 and 9 were 0.6 cm or less. Their 90 % CIs were all below the threshold of 2.4 cm for clinical relevance and included zero, indicating effects were not clinically meaningful or statistically significant. Symmetry analysis showed no significant differences between the number of participants who had SDLP differences >2.4 cm and those who had SDLP differences <-2.4 cm following suvorexant.

conclusionsThere was no clinically meaningful residual effect of suvorexant 15 and 30 mg on next-morning driving (9 h after bedtime dosing) in healthy older adults, as assessed by mean changes in SDLP and by the number of participants on drug versus placebo that exceeded a predetermined threshold for clinically meaningful impairment.

Indexed as

Automobile DrivingAgedAged, 80 and overAzabicyclo CompoundsAzepinesCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansHypnotics and SedativesMalePiperazinesPsychomotor PerformanceSleep Aids, PharmaceuticalAzabicyclo CompoundsAzepinesHypnotics and SedativesPiperazinesSleep Aids, PharmaceuticalsuvorexantTriazoleszopicloneDrivingElderlyHypnoticsOrexin antagonistSuvorexantZopiclone

Identifiers

PMID27424295
PMCPMC4989000

What OpenQuestion holds

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LicenceCC BY
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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.