Anxiety and sleep disorders are common and are associated with a reduced quality of life. Sedatives such as benzodiazepines have anxiolytic effects but impair driving ability. This is associated with significant negative consequences for some individuals. In contrast, a phyto-preparation containing lavender oil with proven anxiety-relieving and mood-lifting effects does not negatively affect driving performance, a new study shows.
Sedation, daytime sleepiness, drowsiness, and reductions in attentional performance and responsiveness are among common adverse effects of conventional synthetic anxiolytics [1]. The DRUID expert group (“Driving under the influence of drugs, alcohol and medicines”) warns in particular of the negative effects of benzodiazepines on driving ability [2]. It has been empirically shown that residual effects with unfavorable effects on driving performance also occur the following day when sedatives are used as sleep aids [3]. These delayed effects include decreased reaction time, reduced alertness, and impaired overall cognitive performance and judgment [4,5]. Phytopharmacological preparations with the active ingredient Silexan® are a well-tolerated treatment alternative with few side effects for anxiety and sleep disorders. In a recent study, the focus was on the effects of this active ingredient on driving ability. The conclusion is extremely positive.
Driving performance under Silexan® similar to placebo condition.
Overall, there was no evidence of side effects affecting driving ability after taking Silexan® as described for benzodiazepines and other synthetic anxiolytics in the literature [9]. The results of the randomized, double-blind, crossover study show that single doses of up to 320 mg of Silexan® and multiple doses of 80 mg have no adverse effects on driving performance. In total, data from 73 healthy subjects in the age range of 25-58 years were analyzed. The primary endpoint was the standard deviation of track position (SDLP). Secondary endpoints were driving errors and drowsiness. The results of Part 1 of the study (n=48) confirm that the effect of Silexan® at a dosage of 80 mg/d on “lane-keeping performance” is comparable to placebo, both after a single dose and after multiple doses over a period of one week. Only minor mean differences were also observed between Silexan® and placebo with regard to the number of driving errors. Kenntner-Mabiala et al. 2015 reported an average increase in total impaired driving of 21.4 at a blood alcohol concentration of 0.5 mg/l (legal limit for driving in Western Europe) compared to 0.0 mg/l [6]. This is a significantly higher error rate than the difference of 3.2 errors between placebo and Silexan® 80 mg reported in the present study.
Better lane keeping performance and fewer driving errors compared to lorazepam.
In Part 2 (n=25), Silexan® was administered at a dose of 160 mg (this therapeutic dose was studied in patients with generalized anxiety disorder) [7] and at a supratherapeutic dose of 320 mg. The choice of lorazepam as a comparator is based on the fact that Silexan® demonstrated similar anxiolytic effects in patients with Generalized Anxiety Disorder in a previous study and lorazepam is one of the commonly used benzodiazepines [8]. Driving performance was evaluated in a validated alcohol-calibrated simulator test. For both doses, superiority of Silexan® over lorazepam 1 mg was demonstrated for lane-keeping performance, with an average SDLP mean difference of at least 5.4 cm (upper limit of 95% CI). The superiority of Silexan® over lorazepam also affected driving errors and self- and other-assessments of overall driving performance.
The only adverse event that occurred significantly more often in the Silexan® condition than in placebo was abdominal tightness (eructation), a known side effect of the herbal medicine. The results of the present study are a valuable addition to previous empirical evidence on the symptom-reducing effects of Silexan® in patients with anxiety, sleep disorders, and related symptomatology.
Literature:
- Hahn M, Roll SC: Benzodiazepines: from wonder drug to risk medication. Pharmaceutical Newspaper (Online), 07 Nov 2019. https://www.pharmazeutische-zeitung.de/, (last accessed Feb. 24, 2021).
- EMCDDA: DRUID project, www.emcdda.europa.eu, (last accessed Feb. 24, 2021).
- Möller H-J, et al: Journal of Psychiatric Research 2020, https://doi.org/10.1016/j.jpsychires.2020.10.028
- Hansen RN, et al: Sedative hypnotic medication use and the risk of motor vehicle crash. Am J Pub. Health 2015, 105 (8): e64-69.
- Leufkens TR, et al. Residual effects of zopiclone 7.5 mg on highway driving performance in insomnia patients and healthy controls: a placebo controlled crossover study. Psychopharmacology (Berl) 2014, 231 (14): 2785-2798.
- Kenntner-Mabiala R, et al: Driving performance under alcohol in simulated representative driving tasks: an alcohol calibration study for impairments related to medicinal drugs. J Clin Psychopharmacol 2015; 35 (2): 134-142.
- Kasper S, et al: Lavender oil preparation Silexan is effective in generalized anxiety disorder – a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol 2014; 17 (6): 859-869.
- Woelk H, Schläfke S: A multi-center, double-blind, randomised study of the lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine 2010; 17: 94-99.
- Dassanayake T, et al. Effects of benzodiazepines, antidepressants and opioids on driving: a systematic review and meta-analysis of epidemiological and experimental evidence. Drug Saf 2011; 34 (2): 125-156.
- Wang CS, Liu DY, Hsu KS: Simulation and application of cooperative driving sense systems using prescan software. Microsyst Technol 2018, https://doi.org/10.1007/s00542-018-4164-z
HAUSARZT PRAXIS 2021; 16(3): 19
InFo NEUROLOGY & PSYCHIATRY 2021; 19(2): 36.
