Zopiclone's residual effects on actual driving performance in a standardized test: a pooled analysis of age and sex effects in 4 placebo-controlled studies?

AbstractBackgroundIn many European countries, Canada, and Japan, the nonbenzodiazepine zopiclone is now among the most frequently prescribed hypnotic drugs. This finding can be explained by the growing view among physicians that zopiclone is more effective and safer than conventional benzodiazepines. However, in 4 studies using similar procedures, it has been shown that zopiclone 7.5 mg causes moderate to severe impairment in driving performance.ObjectiveThe goal of the present article was to review these studies and analyze the pooled data to determine whether the severity of effects is modified by the sex and age of the subjects.MethodsThe driving data of the placebo and zopiclone 7.5 mg evening treatment periods from a total of 4 studies conducted at Maastricht University were included in this pooled analysis. All studies were conducted according to balanced double-blind, crossover designs. The effects on driving were always measured the next morning, between 10 and 11 hours after administration, by using a standardized highway driving test. A total of 101 healthy volunteers of both sexes in equal proportions (with no reports of insomnia) participated. Subjects comprised young volunteers (age range, 21–45 years) in 3 studies and older volunteers (age range, 55–75 years) in the fourth study.ResultsResults show that zopiclone 7.5 mg has significant and clinically relevant performance-impairing effects on driving in the morning, until 11 hours after bedtime ingestion. The effects did not differ between male and female subjects and did not increase with age, at least until 75 years. The effects of zopiclone 7.5 mg are comparable to the effects of a mean blood alcohol concentration between 0.5 and 0.8 mg/mL, which has been associated with a 2- to 3-fold increase in the risk of becoming involved in a traffic accident.ConclusionsWe concluded that patients using an evening dose of zopiclone 7.5 mg should avoid activity in skilled work and participation in traffic the morning after intake. General practitioners’ beliefs regarding the beneficial safety profile of zopiclone may need adjustment, and patients using zopiclone 7.5 mg should be warned accordingly. There is no need to differentiate warnings about zopiclone’s residual impairing effects depending on the sex of the patient

Highway driving in elderly the morning after bedtime use of hypnotics: a comparison between temazepam 20 mg, zopiclone 7.5 mg and placebo

A major problem related to hypnotic drug use is residual sedation the morning after bedtime administration. This constitutes a particular safety hazard for patients who have to drive a car the next morning. Information on the severity of residual effects is mainly derived from studies conducted with young healthy volunteers. However, most users of hypnotics are older people who may be more sensitive to drug effects. The aim of this study was to evaluate the residual effects the morning after evening doses of temazepam 20 mg and zopiclone 7.5 mg on driving performance in healthy elderly drivers. Eighteen healthy elderly drivers (10 females and 8 males; mean age, 64.3 years) participated in a double-blind, 3-way crossover study. Treatments were single oral doses of temazepam 20 mg, zopiclone 7.5 mg, and placebo administered at bedtime. Subjects performed a standardized highway driving test between 10 and 11 hours after hypnotic intake. Before and after the driving test, cognitive performance was assessed. Driving performance did not differ between temazepam and placebo but was significantly impaired after zopiclone 7.5 mg (P <0.002). The results of the laboratory tests were in line with the effects on driving of both hypnotics. Temazepam 20 mg is unlikely to impair driving 10 hours or more after bedtime administration in healthy elderly aged 75 years or younger. Zopiclone 7.5 mg moderately impairs driving in the elderly at least until 11 hours after administration. The magnitude of impairing effects in the elderly was comparable with those found previously in younger volunteers

Highway driving performance and cognitive functioning the morning after bedtime and middle-of-the-night use of gaboxadol, zopiclone and zolpidem

Gaboxadol is a selective extrasynaptic GABA(A) receptor agonist previously in development for the treatment of insomnia. Due to its short half-life (1.5-2 h) it is expected to be free from residual effects the next morning. The present study assessed the residual effects of evening and middle-of-the-night administration of 15 mg of gaboxadol on cognitive, psychomotor and driving performance. Twenty-eight healthy volunteers entered the study with 25 (12 women; mean age 31.4 years) completing a double-blind, placebo-controlled, active-referenced five-way cross-over study. Each treatment night subjects ingested one capsule at 23:00 hours and one at 04:00 hours. Treatments were placebo at both times, 15 mg gaboxadol or 7.5 mg zopiclone followed by placebo, and placebo followed by 15 mg gaboxadol or 10 mg zolpidem. Effects on cognition and psychomotor performance were assessed between 07:30 and 08:30 hours and on driving between 09:00 and 10:00 hours. Driving, as measured by standard deviation of lateral position in an on-the-road driving test, was almost significantly (P <0.07) impaired after evening administration of gaboxadol for the all-subjects-completed set (n = 25) but significantly (P <0.05) in the full analysis set (n = 28). Effects of all other active treatments on driving were significant. Evening administration of gaboxadol had minor effects on divided attention only, whereas middle-of-the-night administration impaired performance significantly in all tests except memory. Zolpidem and zopiclone impaired performance significantly in every test except tracking after zopiclone; 15 mg of gaboxadol can produce minor residual effects on driving after evening administration. Administration later at night is associated with moderately impairing residual effects on driving and psychomotor performance but not on memory

Ambulatory automated auditory partial sleep deprivation affects subjective sleepiness without affecting sleep macro structure

Item does not contain fulltex

Recharge yourself: Recharge interventions during festival-induced sleep loss

Item does not contain fulltex

Insomnia, hypnotic drugs and traffic safety

Sleep medication helps patients who suffer from insomnia to fall asleep and maintain asleep, but unfortunately hypnotic drugs often have residual effects that may affect daily activities such as driving a car. Epidemiological studies show that patients who use sleep medication are at increased risk of becoming involved in traffic accidents. These studies show an increased traffic accident risk for patients using benzodiazepine hypnotics or zopiclone.this chapter reviews the experimental studies assessing the effects of various hypnotic drugs on driving ability. On-the-road studies confirm that benzodiazepine hypnotics and zopiclone significantly impair driving ability the morning following bedtime administration, whereas the z-drugs zolpidem and zaleplon do not affect driving performance when taken as recommended. Impairment was dose dependent and most prominent in benzodiazepines with a relative long half-life.epidemiological studies show that tolerance to the impairing effects on driving ability of hypnotic drugs develops slowly. However, experimental evidence from on-the-road driving studies on the effects of chronic use of hypnotics is currently lacking. Also, the impact of untreated insomnia on driving should be examined in future studies.current hypnotics all act at the gaba receptor which may explain their residual effects on driving performance. Various newly developed hypnotic drugs have a different mechanism of action and may therefore be devoid of residual effects on driving performance.keywordshypnotic drugtraffic accident risksimulated drive performancedvvrfldwhg zlwkvkrz wkdwthese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves