Evidence map›Paper›PMID 35106620›Full record

Trial reportPsychopharmacology2022

Residual effects of zopiclone on driving performance using a standardized driving simulator among healthy volunteers.

Kunihiro Iwamoto, Mari Iwata, Daiji Kambe, Yumiko Imadera, Naoki Tachibana, Yu Kajiyama, Masahiko Ando, Norio Ozaki

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Psychopharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Driving performance of patients with epilepsy undergoing antiepileptic monotherapy.PCN reports : psychiatry and clinical neurosciences · 2023
    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

8 authors at 3 institutions in 1 country.

Kunihiro IwamotoDepartment of Psychiatry, Graduate School of Medicine, Nagoya University, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan. iwamoto@med.nagoya-u.ac.jp.ORCID http://orcid.org/0000-0003-3868-3372
Mari IwataDepartment of Psychiatry, Graduate School of Medicine, Nagoya University, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan.
Daiji KambeTaisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.
Yumiko ImaderaTaisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.
Naoki TachibanaTaisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.
Yu KajiyamaTaisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.
Masahiko AndoDepartment of Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Aichi, 466-8560, Japan.
Norio OzakiDepartment of Psychiatry, Graduate School of Medicine, Nagoya University, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan.
Taisho Pharmaceutical (Japan) · JPNagoya University · JPNagoya University Hospital · JP

Funding

Research on Regulatory Science of Pharmaceuticals and Medical Devices from the Japan Agency for Medical Research and Development JP21mk0101137h0003
6 · The paper itself

Abstract

rationaleThe effects of hypnotics on automobile driving have been attracting increasing attention. However, few driving simulators (DSs) have been confirmed to have acceptable reliability and validity for assessing the next-day residual effects of zopiclone as a positive control on driving performance.

objectiveTo investigate whether a new DS could permit detection of the next-day residual effects of zopiclone on driving performance.

methodsIn this double-blind, randomized, placebo-controlled crossover trial, 28 healthy males received zopiclone 7.5 mg at bedtime on days 1 and 8 and placebo on the other days over a period of 16 days. The participants took part in three driving tasks-road-tracking, car-following, and harsh-braking-using a DS on days 2 and 9 at 9-h post-dosing. Scores on the Karolinska Sleepiness Scale and Profile of Mood States-Second Edition were then assessed, as was the serum concentration of zopiclone.

resultsThe estimated differences in the standard deviation of lateral position (cm) in the road-tracking task between the zopiclone and placebo groups on days 2 and 9 were 3.75 cm (90% confidence interval (CI): 1.71-5.79) and 4.07 cm (90% CI: 2.02-6.11), respectively. The estimated differences in the distance coefficient of variation in the car-following task and in the brake reaction time in the harsh-braking task between the zopiclone and placebo groups on day 2 were 4.31 (90% CI: 1.94-6.69) and 24.6 ms (90% CI: 12.7-36.4), respectively.

conclusionsThe DS used in this study has sufficient sensitivity to detect the next-day residual effects of zopiclone on driving performance.

Indexed as

Automobile DrivingPsychomotor PerformanceAzabicyclo CompoundsCross-Over StudiesDouble-Blind MethodHealthy VolunteersHumansHypnotics and SedativesMalePiperazinesReproducibility of ResultsAzabicyclo CompoundsHypnotics and SedativesPiperazineszopicloneDriving performanceDriving simulatorKunihiro Iwamoto and Mari Iwata joint first authorship and contributed equally to this paperPositive controlSDLPSensitivityZopiclone

Identifiers

PMID35106620
OpenAlexW4210537434

What OpenQuestion holds

Textmetadata
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.