Residual effects of zopiclone 7.5 mg on highway driving performance in insomnia patients and healthy controls: a placebo controlled crossover study

T.R.M. Leufkens, J.G. Ramaekers, A.W. de Weerd, W.J. Riedel, A. Vermeeren

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Scopus)

Abstract

Rationale

Residual effects of hypnotics on driving performance have been mainly determined in studies using a standardized driving test with healthy good sleepers. Responses to effects may differ, however, between insomniacs and healthy volunteers due to the underlying sleep disorder. In addition, a majority of insomniacs uses hypnotics chronically resulting in the development of tolerance to impairing effects. Impaired driving performance in healthy volunteers may then be an overestimation of the actual effects in insomniacs.

Objectives

The present study aims to compare the residual effects of zopiclone 7.5 mg on on-the-road driving performance of 16 middle-aged insomniacs chronically using hypnotics (chronic users), 16 middle-aged insomniacs not or infrequently using hypnotics (infrequent users), and 16 healthy, age matched, good sleepers (controls).

Methods

The study was conducted according to a 3 × 2 double-blind, placebo controlled crossover design, with three groups and two treatment conditions. Treatments were single oral doses of zopiclone 7.5 mg and placebo administered at bedtime (2330 hours). Between 10 and 11 h after administration subjects performed a standardized highway driving test.

Results

Zopiclone 7.5 mg significantly impaired on-the-road driving performance in both insomnia groups and healthy controls. The magnitude of impairment was significantly less in the chronic users group as compared with the controls.

Conclusions

The smaller magnitude of effects suggests that investigating residual effects of hypnotics in healthy volunteers may yield a minor overestimation of the actual effects in insomnia patients
Original languageEnglish
Pages (from-to)2785-2798
Number of pages14
JournalPsychopharmacology
Volume231
Issue number14
Early online date24 Jan 2014
DOIs
Publication statusPublished - Jul 2014

Keywords

  • ALCOHOL
  • BENZODIAZEPINE USE
  • HYPNOTICS
  • Hypnotics
  • INSTRUMENT
  • Insomnia
  • MEMORY
  • On-the-road driving
  • REBOUND INSOMNIA
  • Residual effects
  • SLEEP-DEPRIVATION
  • TRAFFIC ACCIDENTS
  • WITHDRAWAL
  • ZALEPLON
  • Zopiclone

Cite this

@article{dd987bd6fdee4fbfbc22c5350aa4b2dc,
title = "Residual effects of zopiclone 7.5 mg on highway driving performance in insomnia patients and healthy controls: a placebo controlled crossover study",
abstract = "Rationale Residual effects of hypnotics on driving performance have been mainly determined in studies using a standardized driving test with healthy good sleepers. Responses to effects may differ, however, between insomniacs and healthy volunteers due to the underlying sleep disorder. In addition, a majority of insomniacs uses hypnotics chronically resulting in the development of tolerance to impairing effects. Impaired driving performance in healthy volunteers may then be an overestimation of the actual effects in insomniacs. Objectives The present study aims to compare the residual effects of zopiclone 7.5 mg on on-the-road driving performance of 16 middle-aged insomniacs chronically using hypnotics (chronic users), 16 middle-aged insomniacs not or infrequently using hypnotics (infrequent users), and 16 healthy, age matched, good sleepers (controls). Methods The study was conducted according to a 3 × 2 double-blind, placebo controlled crossover design, with three groups and two treatment conditions. Treatments were single oral doses of zopiclone 7.5 mg and placebo administered at bedtime (2330 hours). Between 10 and 11 h after administration subjects performed a standardized highway driving test. Results Zopiclone 7.5 mg significantly impaired on-the-road driving performance in both insomnia groups and healthy controls. The magnitude of impairment was significantly less in the chronic users group as compared with the controls. Conclusions The smaller magnitude of effects suggests that investigating residual effects of hypnotics in healthy volunteers may yield a minor overestimation of the actual effects in insomnia patients",
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author = "T.R.M. Leufkens and J.G. Ramaekers and {de Weerd}, A.W. and W.J. Riedel and A. Vermeeren",
year = "2014",
month = "7",
doi = "10.1007/s00213-014-3447-z",
language = "English",
volume = "231",
pages = "2785--2798",
journal = "Psychopharmacology",
issn = "0033-3158",
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Residual effects of zopiclone 7.5 mg on highway driving performance in insomnia patients and healthy controls: a placebo controlled crossover study. / Leufkens, T.R.M.; Ramaekers, J.G.; de Weerd, A.W.; Riedel, W.J.; Vermeeren, A.

In: Psychopharmacology, Vol. 231, No. 14, 07.2014, p. 2785-2798.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Residual effects of zopiclone 7.5 mg on highway driving performance in insomnia patients and healthy controls: a placebo controlled crossover study

AU - Leufkens, T.R.M.

AU - Ramaekers, J.G.

AU - de Weerd, A.W.

AU - Riedel, W.J.

AU - Vermeeren, A.

PY - 2014/7

Y1 - 2014/7

N2 - Rationale Residual effects of hypnotics on driving performance have been mainly determined in studies using a standardized driving test with healthy good sleepers. Responses to effects may differ, however, between insomniacs and healthy volunteers due to the underlying sleep disorder. In addition, a majority of insomniacs uses hypnotics chronically resulting in the development of tolerance to impairing effects. Impaired driving performance in healthy volunteers may then be an overestimation of the actual effects in insomniacs. Objectives The present study aims to compare the residual effects of zopiclone 7.5 mg on on-the-road driving performance of 16 middle-aged insomniacs chronically using hypnotics (chronic users), 16 middle-aged insomniacs not or infrequently using hypnotics (infrequent users), and 16 healthy, age matched, good sleepers (controls). Methods The study was conducted according to a 3 × 2 double-blind, placebo controlled crossover design, with three groups and two treatment conditions. Treatments were single oral doses of zopiclone 7.5 mg and placebo administered at bedtime (2330 hours). Between 10 and 11 h after administration subjects performed a standardized highway driving test. Results Zopiclone 7.5 mg significantly impaired on-the-road driving performance in both insomnia groups and healthy controls. The magnitude of impairment was significantly less in the chronic users group as compared with the controls. Conclusions The smaller magnitude of effects suggests that investigating residual effects of hypnotics in healthy volunteers may yield a minor overestimation of the actual effects in insomnia patients

AB - Rationale Residual effects of hypnotics on driving performance have been mainly determined in studies using a standardized driving test with healthy good sleepers. Responses to effects may differ, however, between insomniacs and healthy volunteers due to the underlying sleep disorder. In addition, a majority of insomniacs uses hypnotics chronically resulting in the development of tolerance to impairing effects. Impaired driving performance in healthy volunteers may then be an overestimation of the actual effects in insomniacs. Objectives The present study aims to compare the residual effects of zopiclone 7.5 mg on on-the-road driving performance of 16 middle-aged insomniacs chronically using hypnotics (chronic users), 16 middle-aged insomniacs not or infrequently using hypnotics (infrequent users), and 16 healthy, age matched, good sleepers (controls). Methods The study was conducted according to a 3 × 2 double-blind, placebo controlled crossover design, with three groups and two treatment conditions. Treatments were single oral doses of zopiclone 7.5 mg and placebo administered at bedtime (2330 hours). Between 10 and 11 h after administration subjects performed a standardized highway driving test. Results Zopiclone 7.5 mg significantly impaired on-the-road driving performance in both insomnia groups and healthy controls. The magnitude of impairment was significantly less in the chronic users group as compared with the controls. Conclusions The smaller magnitude of effects suggests that investigating residual effects of hypnotics in healthy volunteers may yield a minor overestimation of the actual effects in insomnia patients

KW - ALCOHOL

KW - BENZODIAZEPINE USE

KW - HYPNOTICS

KW - Hypnotics

KW - INSTRUMENT

KW - Insomnia

KW - MEMORY

KW - On-the-road driving

KW - REBOUND INSOMNIA

KW - Residual effects

KW - SLEEP-DEPRIVATION

KW - TRAFFIC ACCIDENTS

KW - WITHDRAWAL

KW - ZALEPLON

KW - Zopiclone

U2 - 10.1007/s00213-014-3447-z

DO - 10.1007/s00213-014-3447-z

M3 - Article

VL - 231

SP - 2785

EP - 2798

JO - Psychopharmacology

JF - Psychopharmacology

SN - 0033-3158

IS - 14

ER -