Evidence map›Paper›PMID 24587571›Full record

Trial reportSleep2014

Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use.

Annemiek Vermeeren, Eric F P M Vuurman, Tim R M Leufkens, Cees J Van Leeuwen, Anita C M Van Oers, Eugene Laska, Salvador Rico, Frank Steinberg, Thomas Roth

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01106859 (Assessment of Next-Morning Driving Performance After Middle of the Night Administration of Zolpidem Tartrate Sublingual Tablet 3.5 mg in Healthy Adult Volunteers), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

NCT01106859 phase1completednot on this map

Assessment of Next-Morning Driving Performance After Middle of the Night Administration of Zolpidem Tartrate Sublingual Tablet 3.5 mg in Healthy Adult Volunteers: Single-center, Double-blind, Randomized, Placebo-controlled, Four-way Crossover Study

TypeinterventionalSponsorTranscept PharmaceuticalsRan2010 to 2010Enrolled40ConditionsInsomniaArmszopiclone, zolpidem tartrate sublingual tablet, Placebo (sublingual tablet), Placebo
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Trial
  3. Trial
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  5. Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) · 2020
    Trial
  6. Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. People with insomnia: experiences with sedative hypnotics and risk perception.Health expectations : an international journal of public participation in health care and health policy · 2016
    Article
  18. Sleeping Pill Administration Time and Patient Subjective Satisfaction.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2016
    Article
  19. Article
  20. Article
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

9 authors.

Annemiek VermeerenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Eric F P M VuurmanDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Tim R M LeufkensDepartment 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.
Eugene LaskaNathan Kline Institute for Psychiatric Research, Orangeburg, NY and New York University, Langone School of Medicine, New York, NY.
Salvador RicoTranscept Pharmaceuticals, Inc., Point Richmond, CA.
Frank SteinbergTranscept Pharmaceuticals, Inc., Point Richmond, CA.
Thomas RothHenry Ford Hospital Sleep Disorders and Research Center, Detroit, MI.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectiveTo evaluate next-morning driving performance after middle-of-the-night use of zolpidem 3.5 mg in a buffered sublingual formulation (ZST).

designSingle-center, four-period, randomized, double-blind, placebo-controlled, crossover study.

settingMaastricht University, The Netherlands.

participantsForty healthy volunteers (20 females).

interventionsSingle dose of ZST administered in the middle of the night at 3 and 4 h before driving, zopiclone 7.5 mg at bedtime 9 h before driving, and placebo. MEASUREMENTS: Performance in a 100-km standardized highway driving test in normal traffic measuring standard deviation of lateral position (SDLP) - an index of weaving. Drug-placebo changes in SDLP > 2.5 cm were considered to reflect clinically relevant driving impairment.

resultFor ZST, Max McNemar symmetry analyses showed that the proportion of drivers classified as impaired was increased 3 h after dosing (P < 0.012), but not 4 h after dosing. Mean increases in SDLP from placebo, although statistically significant, were small (1.46 cm [P < 0.0001] at 3 h and 0.83 cm [P = 0.0174] at 4 h). The morning after zopiclone, 45% of the drivers were classified as impaired with a mean increase in SDLP of 2.46 cm (P < 0.0001). There were no significant sex differences in effects of ZST and zopiclone.

conclusionZolpidem 3.5 mg in a buffered sublingual formulation has a minimal risk of impairing driving performance in the morning ≥ 4 hours after middle-of-the night use. When taken 3 hours before driving, the drug may have impairing effects so caution should be exercised if medication is taken other than as indicated. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov Identifier: NCT01106859; Trial Name: Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet; http://clinicaltrials.gov/ct2/show/NCT01106859.

Indexed as

Administration, SublingualAdultAutomobile DrivingAzabicyclo CompoundsCross-Over StudiesDouble-Blind MethodFemaleHumansHypnotics and SedativesMaleMiddle AgedMotor SkillsNetherlandsPiperazinesPyridinesSex CharacteristicsAzabicyclo CompoundsHypnotics and SedativesPiperazinesPyridinesZolpidemzopicloneDrivinghypnoticssexzolpidem sublingualzopiclone

Identifiers

PMID24587571
PMCPMC3920314

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.