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

Abstract

RationaleResidual 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.ObjectivesThe 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).MethodsThe 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.ResultsZopiclone 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.ConclusionsThe 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.

Driving performance of stable outpatients with depression undergoing real‐world treatment

“…On the other hand, a recent systematic review showed that pharmacotherapy, including augmentation therapy with antipsychotics, may reduce cognitive impairment in depressed patients . Antidepressants can improve driving performance in untreated patients with depression and administration of psychotropics, including antidepressants and hypnotics, can decrease a drug's influence on driving performance . Because we did not examine driving performance over time, further research is needed regarding the confounding of depression and pharmacotherapy.…”

Evaluation method regarding the effect of psychotropic drugs on driving performance: A literature review

“…The highway driving test (HDT) performed in the Netherlands was frequently used in ORT (40 studies out of 67). In the HDT, the examiner sits in the passenger seat, which has an operator function (i.e., a steering wheel and a pedal), and the subject drives 100 km on a highway at a speed of 95 km/h.…”

“…The most commonly used drug was zopiclone. Because a significant deterioration of driving skill after ingestion has been recognized, zopiclone was commonly used as a comparative control when investigating hypnotics. Amitriptyline, which has also been shown to affect driving skill, was commonly used as a positive control for antidepressants.…”

“…The SD of the lateral position (SDLP), which is the most commonly utilized measurement in the evaluation index, was used in 54 of 121 studies. Four studies used similar evaluation indices without referencing SDLP. In HDT involving ORT, the subjects were tested for about 1–2 h while maintaining a speed between 95 km/h and 100 km/h.…”

New, Occasional, and Frequent Use of Zolpidem or Zopiclone (Alone and in Combination) and the Risk of Injurious Road Traffic Crashes in Older Adult Drivers: A Population-Based Case–Control and Case-Crossover Study

“…While zolpidem was deemed safer following bedtime use, middle-of-the-night administration showed this medication can also impair driving performance the morning after [10, 12]. It is important to bear in mind that, whereas the majority of these trials included only healthy young adults, other studies with middle-aged and elderly drivers have also shown similar findings [11, 15]. …”