Hypnotics and Driving Safety: Meta-Analyses of Randomized Controlled Trials Applying the on-the-Road Driving Test

Abstract

Abstract:Background: Many people who use hypnotics are outpatients and are likely to drive a car the day after drug intake. The purpose of these meta-analyses was to determine whether or not this is safe.Methods: Placebo-controlled, randomized, double-blind trials were selected if using the on-the-road driving test to determine driving ability the day following one or two nights of treatment administration. Primary outcome measure of the driving test was the Standard Deviation of Lateral Position (SDLP); i.e., the weaving of the car. Fixed effects model meta-analyses were performed. Effect size (ES) was computed using mean standardized (weighted) difference scores between treatment and corresponding placebo SDLP values.Results: Ten studies, published from 1984 to 2002 (207 subjects), were included in the meta-analyses. The morning following bedtime administration, i.e. 10-11 hours after dosing, significant driving impairment was found for the recommended dose of various benzodiazepine hypnotics (ES=0.42; 95% Confidence Interval (CI)=0.14 to 0.71). Twice the recommended dose impaired driving both in the morning (ES=0.68; CI=0.39 to 0.97) and afternoon, i.e. 16-17 hours after dosing (ES=0.57; CI=0.26 to 0.88). Zopiclone 7.5 mg also impaired driving in the morning (ES=0.89; CI=0.54 to 1.23). Zaleplon (10 and 20 mg) and zolpidem (10 mg) did not affect driving performance the morning after dosing. Following middle-of-the-night administration, significantly impaired driving performance was found for zopiclone 7.5 mg (ES=1.51, CI=0.85 to 2.17), zolpidem 10 mg (ES=0.66, CI=0.13 to 1.19) and zolpidem 20 mg (ES=1.16, CI=0.60 to 1.72). Zaleplon (10 and 20 mg) did not affect driving performance. Conclusions:The analyses show that driving a car the morning following nocturnal treatment with benzodiazepines and zopiclone is unsafe, whereas the recommended dose of zolpidem (10 mg) and zaleplon (10 mg) do not affect driving ability.

The Dual Hypocretin Receptor Antagonist Almorexant is Permissive for Activation of Wake-Promoting Systems

“…ZOL and similar drugs like eszopiclone are widely prescribed and generally considered effective at inducing sleep (Greenblatt and Roth, 2012), but their use is associated with a high incidence of adverse effects such as driving impairment (Gunja, 2013;Verster et al, 2006), memory impairment (Balkin et al, 1992;Mintzer and Griffiths, 1999;Wesensten et al, 1995Wesensten et al, , 1996, complex sleep behaviors (Chen et al, 2014;Dolder and Nelson, 2008), and psychomotor deficits (Storm et al, 2007;Wesensten et al, 2005), highlighting the need for hypnotics that induce lessfunctional impairment. ALM and other HcrtR antagonists effectively induce sleep (Brisbare-Roch et al, 2007;Cox et al, 2010) but cause less impairment in memory tasks (Dietrich and Jenck, 2010;Morairty et al, 2014) or motor function in rodents (Ramirez et al, 2013;Steiner et al, 2011), dogs (Tannenbaum et al, 2014), and non-human primates (Uslaner et al, 2013) than do traditional hypnotics.…”

Mortality Risk of Hypnotics: Strengths and Limits of Evidence

“…Also, controlled trials prove that many hypnotics impair next-day driving performance. Moreover, hypnotics are epidemiologically associated with an increased rate of driver-at-fault vehicle crashes as well as falls and serious infections [13,[27][28][29][30][31][32][33][34][35][36]. Other studies show that hypnotic use is associated with new cancer incidence [37][38][39].…”

Sleep Specialists^|^rsquo; Opinion on Sleep Disorders and Fitness to Drive a Car: The Necessity of Continued Education

“…Finally, although it is believed that driving is impaired in insomnia patients, there is no scientific proof that this actually is the case. There is, however, abundant scientific literature reporting the effects of hypnotic drugs on driving ability 23,24) .…”