Driving ability after acute and sub-chronic administration of levocetirizine and diphenhydramine: a randomized, double-blind, placebo-controlled trial
Sedation following antihistamine use poses a danger to ambulant patients involved in daily activities such as driving.
To investigate effects of levocetirizine (5 mg), diphenhydramine (50 mg), and placebo on driving ability during normal traffic.
Forty-eight healthy volunteers participated in a double-blind, placebo-controlled, randomized clinical trial. Treatments were administrated on days 1, 2, 3 and 4, exactly 1.5 h before the start of the standardized driving test (performed on day 1 and day 4). In the standardized driving test, subjects were instructed to drive with a steady lateral position, while maintaining a constant speed (95 km/h). Primary parameter was the standard deviation of lateral position (SDLP; cm). Statistical analyses were performed separately for day 1 and day 4, using analysis of variance and an equivalence test. Equivalence to placebo was evidenced if the 95% confidence interval lay between −2.6 cm and +2.6 cm.
SDLP after levocetirizine was equivalent to placebo on both day 1 (−0.66 cm; +1.12 cm) and day 4 (−0.37 cm; +1.28 cm). In contrast, SDLP after diphenhydramine differed significantly from placebo on both day 1 (P<0.0001) and day 4 (P<0.0003). On day 1, the 95% confidence interval of diphenhydramine (+1.85 cm; +3.63 cm) was partially above the upper equivalence limit (+2.6 cm), indicating clinically relevant driving impairment. On day 4, however, the 95% confidence interval of diphenhydramine (+0.74 cm; +2.38 cm) was contained within the acceptance range.
In contrast to diphenhydramine, driving performance was not significantly affected while using 5 mg levocetirizine once daily.
KeywordsLevocetirizine Diphenhydramine Antihistamine Driving
- Borkenstein RF, Crowther RP, Shumate RP, Ziel HB, Zylman R (1964) The role of the drinking driver in traffic accidents. Dept. of Police Administration, Indiana University, Bloomington, IndianaGoogle Scholar
- Louwerens JW, Gloerich ABM, De Vries G, Brookhuis KA, O'Hanlon JF (1987) The relationship between drivers' blood alcohol concentration (BAC) and actual driving performance during high speed travel. In: Noordzij PC, Roszbach R (eds) Alcohol, drugs and traffic safety. Proceedings of the 10th International Conference on Alcohol, Drugs and Traffic Safety, Amsterdam, Excerpta Medica, pp 183–192Google Scholar
- Ramaekers JG, O'Hanlon JF (1994) Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing. J Clin Pharmacol 47:261–266Google Scholar
- Roehrs T, Claiborue D, Knox M, Roth T (1993b) Effects of ethanol, diphenhydramine, and triazolam after a nap. Neuropsychopharmacology 9:239–245Google Scholar
- Verster JC, Volkerts ER, van Oosterwijck AWWA, Aarab M, Bijtjes SIR, de Weert AM, Eijken EJE, Verbaten MN (2003) Acute and subchronic effects of levocetirizine and diphenhydramine on memory functioning, psychomotor performance, and mood. J Allergy Clin Immunol 111:623–627CrossRefPubMedGoogle Scholar
- Volkerts ER, Van Laar MW (1995) Specific review of psychometric effects of cetirizine. Allergy 50:55–60Google Scholar
- Volkerts ER, van Willigenburg PP, van Laar MW, Maes RAA (1992) Does cetirizine belong to the new generation of antihistamines? An investigation into its acute and subchronic effects on highway driving, psychometric test performance, and EEG during driving. Hum Psychopharmacol 7:227–238Google Scholar