RATIONALE: Although hypnotics are primarily used by older people, the residual effects the morning after a single nighttime intake of the two most commonly prescribed hypnotics, zolpidem (Zp) and zopiclone (Zc), on older middle-aged drivers have not been evaluated and compared. METHODS:Sixteen healthy subjects, 55 to 65 years of age, participated in this double-blind, balanced, cross-over study. Zc (7.5 mg), Zp (10 mg) and flunitrazepam (Fln) (1 mg) or a placebo was administered at each subject's home at 11.00 pm. The next morning, at 9.00 am, the subjects had to drive in a simulated monotonous driving environment for 1 h. During each morning session, two blood samples were collected, and subjective feelings of alertness were completed three times. RESULTS: In comparison to placebo, Zp and Zc equivalently and significantly impaired the standard deviation of lateral position, the standard deviation of speed and the number of road exits. Detectable blood concentrations were found with Zp in 11 subjects at 8.30 am and at 1.30 pm. The subjective alertness factor was significantly impaired with Zp. CONCLUSIONS: This is the first study revealing residual effects of Zp on driving performance in ageing drivers which are similar to that of Zc. Studying the effects of medication in different age ranges appears useful to complete the studies on behavioural-pharmacological effects of medication. To reduce the incidence of driving accidents due to prescription drugs, patients should be warned at the time of treatment initiation that they should avoid driving.
RCT Entities:
RATIONALE: Although hypnotics are primarily used by older people, the residual effects the morning after a single nighttime intake of the two most commonly prescribed hypnotics, zolpidem (Zp) and zopiclone (Zc), on older middle-aged drivers have not been evaluated and compared. METHODS: Sixteen healthy subjects, 55 to 65 years of age, participated in this double-blind, balanced, cross-over study. Zc (7.5 mg), Zp (10 mg) and flunitrazepam (Fln) (1 mg) or a placebo was administered at each subject's home at 11.00 pm. The next morning, at 9.00 am, the subjects had to drive in a simulated monotonous driving environment for 1 h. During each morning session, two blood samples were collected, and subjective feelings of alertness were completed three times. RESULTS: In comparison to placebo, Zp and Zc equivalently and significantly impaired the standard deviation of lateral position, the standard deviation of speed and the number of road exits. Detectable blood concentrations were found with Zp in 11 subjects at 8.30 am and at 1.30 pm. The subjective alertness factor was significantly impaired with Zp. CONCLUSIONS: This is the first study revealing residual effects of Zp on driving performance in ageing drivers which are similar to that of Zc. Studying the effects of medication in different age ranges appears useful to complete the studies on behavioural-pharmacological effects of medication. To reduce the incidence of driving accidents due to prescription drugs, patients should be warned at the time of treatment initiation that they should avoid driving.
Authors: D J Greenblatt; J S Harmatz; L L von Moltke; B L Ehrenberg; L Harrel; K Corbett; M Counihan; J A Graf; M Darwish; P Mertzanis; P T Martin; W H Cevallos; R I Shader Journal: Clin Pharmacol Ther Date: 1998-11 Impact factor: 6.875
Authors: Arthur A Simen; Cynthia Gargano; Jang-Ho Cha; Melissa Drexel; An Bautmans; Ingeborg Heirman; Tine Laethem; Thomas Hochadel; Lien Gheyle; Kim Bleys; Chan Beals; Aubrey Stoch; Gary G Kay; Arie Struyk Journal: Ther Adv Drug Saf Date: 2015-06
Authors: Carolyn T Thorpe; Holly C Lassila; Christine K O'Neil; Joshua M Thorpe; Joseph T Hanlon; Robert L Maher Journal: Am J Geriatr Pharmacother Date: 2012-02
Authors: John N Booth; Michael Behring; Ryan S Cantor; Lisandro D Colantonio; Sherri Davidson; John P Donnelly; Erica Johnson; Kelsey Jordan; Chelsea Singleton; Fenglong Xie; Gerald McGwin Journal: Sleep Med Date: 2015-12-29 Impact factor: 3.492