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A randomized, placebo-controlled trial in the Iowa driving simulator J M Weiler^ 1 , J R Bloomfield, G G Woodworth, A R Grant, T A Layton , T L Brown, D R McKenzie, T W Baker, G S Watson Affiliations Expand Affiliation * ^1 Department of Internal Medicine, University of Iowa, Iowa City 52242-1081, USA. john-weiler@uiowa.edu * PMID: 10691585 * DOI: 10.7326/0003-4819-132-5-200003070-00004 Item in Clipboard Clinical Trial Effects of fexofenadine, diphenhydramine, and alcohol on driving performance. A randomized, placebo-controlled trial in the Iowa driving simulator J M Weiler et al. Ann Intern Med. 2000. Show details Display options Display options Format [Abstract] Ann Intern Med Actions * Search in PubMed * Search in NLM Catalog * Add to Search . 2000 Mar 7;132(5):354-63. doi: 10.7326/0003-4819-132-5-200003070-00004. Authors J M Weiler^ 1 , J R Bloomfield, G G Woodworth, A R Grant, T A Layton , T L Brown, D R McKenzie, T W Baker, G S Watson Affiliation * ^1 Department of Internal Medicine, University of Iowa, Iowa City 52242-1081, USA. john-weiler@uiowa.edu * PMID: 10691585 * DOI: 10.7326/0003-4819-132-5-200003070-00004 Item in Clipboard Full text links Cite Display options Display options Format [Abstract] Abstract Background: Sedating antihistamines may impair driving performance as seriously as alcohol. Objective: To compare the effects of fexofenadine, diphenhydramine, alcohol, and placebo on driving performance. Design: Randomized, double-blind, double-dummy, four-treatment, four-period crossover trial. Setting: The Iowa Driving Simulator. Participants: 40 licensed drivers with seasonal allergic rhinitis who were 25 to 44 years of age. Intervention: One dose of fexofenadine (60 mg), diphenhydramine (50 mg), alcohol (approximately 0.1% blood alcohol concentration), or placebo, given at weekly intervals before participants drove for 1 hour in the Iowa Driving Simulator. Measurements: The primary end point was coherence, a continuous measure of participants' ability to match the varying speed of a vehicle that they were following. Secondary end points were drowsiness and other driving measures, including lane keeping and response to a vehicle that unexpectedly blocked the lane ahead. Results: Participants had significantly better coherence after taking alcohol or fexofenadine than after taking diphenhydramine. Lane keeping (steering instability and crossing the center line) was impaired after alcohol and diphenhydramine use compared with fexofenadine use. Mean response time to the blocking vehicle was slowest after alcohol use (2.21 seconds) compared with fexofenadine use (1.95 seconds). Self-reported drowsiness did not predict lack of coherence and was weakly associated with minimum following distance, steering instability, and leftlane excursion. Conclusions: Participants had similar performance when treated with fexofenadine or placebo. After alcohol use, participants performed the primary task well but not the secondary tasks; as a result, overall driving performance was poorer. After participants took diphenhydramine, driving performance was poorest, indicating that diphenhydramine had a greater impact on driving than alcohol did. Drowsiness ratings were not a good predictor of impairment, suggesting that drivers cannot use drowsiness to indicate when they should not drive. Comment in * Nonsedating antihistamines should be preferred over sedating antihistamines in patients who drive. Hennessy S, Strom BL. Hennessy S, et al. Ann Intern Med. 2000 Mar 7;132(5):405-7. doi: 10.7326/0003-4819-132-5-200003070-00011. Ann Intern Med. 2000. PMID: 10691592 No abstract available. * Drug effects on driving performance. de Waard D, Brookhuis KA. de Waard D, et al. Ann Intern Med. 2000 Oct 17;133(8):656; author reply 657-8. doi: 10.7326/ 0003-4819-133-8-200010170-00021. Ann Intern Med. 2000. PMID: 11033599 No abstract available. * Drug effects on driving performance. Lee TH, Dudley J, Demonaco HJ. Lee TH, et al. Ann Intern Med. 2000 Oct 17;133(8):656-7; author reply 657-8. doi: 10.7326/ 0003-4819-133-8-200010170-00022. Ann Intern Med. 2000. PMID: 11033600 No abstract available. * Drug effects on driving performance. Angello JT, Druce HM. Angello JT, et al. Ann Intern Med. 2000 Oct 17;133(8):657; author reply 657-8. doi: 10.7326/ 0003-4819-133-8-200010170-00023. Ann Intern Med. 2000. PMID: 11033601 No abstract available. Similar articles * A simulated car-driving study on the effects of acute administration of levocetirizine, fexofenadine, and diphenhydramine in healthy Japanese volunteers. Inami A, Matsuda R, Grobosch T, Komamura H, Takeda K, Yamada Y, Miyake M, Hiraoka K, Maurer M, Yanai K, Tashiro M. Inami A, et al. Hum Psychopharmacol. 2016 May;31(3):167-77. doi: 10.1002/ hup.2524. Epub 2016 Mar 21. Hum Psychopharmacol. 2016. PMID: 26999510 Clinical Trial. * A single-center, randomized, double-blind, placebo-controlled, crossover investigation of the effects of fexofenadine hydrochloride 180 mg alone and with alcohol, with hydroxyzine hydrochloride 50 mg as a positive internal control, on aspects of cognitive and psychomotor function related to driving a car. Ridout F, Shamsi Z, Meadows R, Johnson S, Hindmarch I. Ridout F, et al. Clin Ther. 2003 May;25(5):1518-38. doi: 10.1016/s0149-2918 (03)80137-6. Clin Ther. 2003. PMID: 12867226 Clinical Trial. * Effects of fexofenadine, diphenhydramine, and placebo on performance of the test of variables of attention (TOVA). Mansfield L, Mendoza C, Flores J, Meeves SG. Mansfield L, et al. Ann Allergy Asthma Immunol. 2003 May;90(5):554-9. doi: 10.1016/ S1081-1206(10)61850-9. Ann Allergy Asthma Immunol. 2003. PMID: 12775138 Clinical Trial. * The systemic safety of fexofenadine HCl. Mason J, Reynolds R, Rao N. Mason J, et al. Clin Exp Allergy. 1999 Jul;29 Suppl 3:163-70; discussion 171-3. doi: 10.1046/ j.1365-2222.1999.0290s3163.x. Clin Exp Allergy. 1999. PMID: 10444232 Review. * A review of the efficacy of desloratadine, fexofenadine, and levocetirizine in the treatment of nasal congestion in patients with allergic rhinitis. Bachert C. Bachert C. Clin Ther. 2009 May;31(5):921-44. doi: 10.1016/j.clinthera.2009.05.017. Clin Ther. 2009. PMID: 19539095 Review. See all similar articles Cited by 30 articles * The Role of Cetirizine in the Changing Landscape of IV Antihistamines: A Narrative Review. Blaiss MS, Bernstein JA, Kessler A, Pines JM, Camargo CA Jr, Fulgham P, Haumschild R, Rupp K, Tyler T, Moellman J. Blaiss MS, et al. Adv Ther. 2022 Jan;39(1):178-192. doi: 10.1007/ s12325-021-01999-x. Epub 2021 Dec 4. Adv Ther. 2022. PMID: 34862952 Free PMC article. Review. * A Randomized, Double-Blind, Placebo-Controlled Trial of a Polyphenol Botanical Blend on Sleep and Daytime Functioning. Tubbs AS, Kennedy KER, Alfonso-Miller P, Wills CCA, Grandner MA. Tubbs AS, et al. Int J Environ Res Public Health. 2021 Mar 16;18 (6):3044. doi: 10.3390/ijerph18063044. Int J Environ Res Public Health. 2021. PMID: 33809544 Free PMC article. Clinical Trial. * Medication use and driving patterns in older drivers: preliminary findings from the LongROAD study. Hill LL, Andrews H, Li G, DiGuiseppi CG, Betz ME, Strogatz D, Pepa P, Eby DW, Merle D, Kelley-Baker T, Jones V, Pitts S. Hill LL, et al. Inj Epidemiol. 2020 Aug 3;7(1):38. doi: 10.1186/ s40621-020-00265-y. Inj Epidemiol. 2020. PMID: 32741358 Free PMC article. * Antihistamine effects and safety of fexofenadine: a systematic review and Meta-analysis of randomized controlled trials. Huang CZ, Jiang ZH, Wang J, Luo Y, Peng H. Huang CZ, et al. BMC Pharmacol Toxicol. 2019 Nov 29;20(1):72. doi: 10.1186/ s40360-019-0363-1. BMC Pharmacol Toxicol. 2019. PMID: 31783781 Free PMC article. * CSACI position statement: Newer generation H[1]-antihistamines are safer than first-generation H[1]-antihistamines and should be the first-line antihistamines for the treatment of allergic rhinitis and urticaria. Fein MN, Fischer DA, O'Keefe AW, Sussman GL. Fein MN, et al. Allergy Asthma Clin Immunol. 2019 Oct 1;15:61. doi: 10.1186/ s13223-019-0375-9. eCollection 2019. Allergy Asthma Clin Immunol. 2019. PMID: 31582993 Free PMC article. Review. 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