Evidence map›Paper›PMID 21966064›Full record

Trial reportSleep2011

Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects.

Monique A J Mets, Juna M de Vries, Lieke M de Senerpont Domis, Edmund R Volkerts, Berend Olivier, Joris C Verster

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

Trial report in Sleep, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00319215 (A Study to Investigate the Residual Effects of Ramelteon), which is not on this map. Cited by 44 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT00319215 phase1completednot on this map

A Study to Investigate the Residual Effects of Ramelteon (8 mg), Zopiclone (7.5 mg) and Placebo on Actual Driving, Memory, Psychomotor Performance and Mood

TypeinterventionalSponsorUtrecht Institute for Pharmaceutical SciencesRan2006 to 2006Enrolled30ConditionsInsomniaArmsRamelteon 8 mg, Zopiclone 7.5 mg
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.

  1. Pooled it
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  3. Pharmacotherapy Treatment Options for Insomnia: A Primer for Clinicians.International journal of molecular sciences · 2015
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  15. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2014
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Monique A J MetsUtrecht University, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacology, Utrecht, The Netherlands. m.a.j.mets@uu.nl
Juna M de Vries
Lieke M de Senerpont Domis
Edmund R Volkerts
Berend Olivier
Joris C Verster
Pharmo Institute · NLUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo evaluate the next-morning residual effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects following bedtime dosing and a middle of the night awakening.

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

settingUtrecht University, The Netherlands.

participants30 healthy volunteers (15 males and 15 females).

interventionsa single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo, administered at bedtime. MEASUREMENTS: A balance test was performed at night. Other tests were performed the following morning, 8.5 h after administration. Subjects performed a 100-km highway driving test in normal traffic. Primary outcome measure was the standard deviation of the lateral position (SDLP), i.e., the weaving of the car. After driving, cognitive, memory, and psychomotor tests were performed and mood was assessed.

resultsSDLP was significantly increased after the intake of ramelteon (+2.2 cm) and zopiclone (+2.9 cm). Ramelteon and zopiclone produced significant impairment on reaction time (P<0.024) in the Sternberg Memory Scanning Test, slow (P<0.007) and fast (P<0.010) tracking, reaction speed (P<0.015) and tracking (P<0.001) in the Divided Attention Test, and delayed recall (P<0.032) in the Word Learning Test. In contrast to ramelteon, zopiclone additionally impaired performance on the Digit Symbol Substitution Test (P<0.001) and the balance test (P<0.001).

conclusionsRamelteon (8 mg) and zopiclone (7.5 mg) significantly impaired driving performance, cognitive, memory, and psychomotor performance the morning following bedtime administration. In contrast to zopiclone, ramelteon produced no balance impairments. CLINICAL TRIAL IDENTIFIER: NCT00319215 (www.clinicaltrials.gov).

Indexed as

Automobile DrivingAdultAffectAzabicyclo CompoundsCross-Over StudiesDouble-Blind MethodFemaleHumansHypnotics and SedativesIndenesMaleMemoryMiddle AgedNeuropsychological TestsPiperazinesPsychomotor PerformanceAzabicyclo CompoundsHypnotics and SedativesIndenesPiperazinesramelteonzopiclonebalanceDrivingmemorypsychomotorramelteonzopiclone

Identifiers

PMID21966064
PMCPMC3173578
OpenAlexW1969619164

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.