Zopiclone's residual effects on actual driving performance in a standardized test: A pooled analysis of age and sex effects in 4 placebo-controlled studies

Clinical Therapeutics

Volumn 36, Issue 1, 2014, Pages 141-150

  Leufkens, Tim R M ^a   Vermeeren, A ^b  

^a PHILIPS RESEARCH LABORATORIES   (Netherlands)

^b MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

hypnotics; on the road driving; residual effects; zopiclone

Indexed keywords

ALCOHOL; GABOXADOL; PLACEBO; TEMAZEPAM; ZALEPLON; ZOLPIDEM; ZOPICLONE;

AGE DISTRIBUTION; ALCOHOL BLOOD LEVEL; ARTICLE; BEDTIME DOSAGE; CAR DRIVING; DRIVING ABILITY; DRUG EFFECT; DRUG SAFETY; EVENING DOSAGE; HIGHWAY; HUMAN; SEX DIFFERENCE; SINGLE DRUG DOSE; STUDY DESIGN; TRAFFIC ACCIDENT;

HYPNOTICS; ON-THE-ROAD DRIVING; RESIDUAL EFFECTS; ZOPICLONE;

ADULT; AGED; AUTOMOBILE DRIVING; AZABICYCLO COMPOUNDS; CLINICAL TRIALS AS TOPIC; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ETHANOL; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MIDDLE AGED; PIPERAZINES; PSYCHOMOTOR PERFORMANCE; YOUNG ADULT;

EID: 84892370957     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2013.11.005     Document Type: Review

References (46)

1. Y. Dündar, A. Boland, and J. Strobl et al. Newer hypnotic drugs for the short-term management of insomnia: a systematic review and economic evaluation Health Technol Assess 8 2004 1 125
2. U.E. Busto, B.A. Sproule, K. Knight, and N. Herrmann Use of prescription and nonprescription hypnotics in a Canadian elderly population Can J Clin Pharmacol 8 2001 213 221
3. G. Hajak, W.E. Muller, and H.U. Wittchen et al. Abuse and dependence potential for the non-benzodiazepine hypnotics zolpidem and zopiclone: a review of case reports and epidemiological data Addict Abingdon Engl 98 2003 1371 1378
4. A. Kassam, B. Carter, and S.B. Patten Sedative hypnotic use in Alberta Can J Psychiatry 51 2006 287 294
5. A.N. Siriwardena, M.Z. Qureshi, and J.V. Dyas et al. Magic bullets for insomnia? Patients' use and experiences of newer (Z drugs) versus older (benzodiazepine) hypnotics for sleep problems in primary care Br J Gen Pract 58 2008 417 422
6. CVZ. Aantal voorschriften 2003-2007 voor ATC-subgroep N05Câ€̄: Hypnotica en sedativa (Number of prescriptions of ATC-subgroup N05C: Hypnotics and sedatives). http://www.gipdatabank.nl/. Accessed July 18, 2013.
7. J. Montplaisir, R. Hawa, and H. Moller et al. Zopiclone and zaleplon vs benzodiazepines in the treatment of insomnia: Canadian consensus statement Hum Psychopharmacol 18 2003 29 38
8. A.N. Siriwardena, Z. Qureshi, and S. Gibson et al. GPs' attitudes to benzodiazepine and "Z-drug" prescribing: a barrier to implementation of evidence and guidance on hypnotics Br J Gen Pract 56 2006 964 967
9. R.H. Farkas, E.F. Unger, and R. Temple Zolpidem and driving impairment - identifying persons at risk N Engl J Med 369 2013 689 691
10. A. Vermeeren, P.E. Danjou, and J.F. O'Hanlon Residual effects of evening and middle-of-the-night administration of zaleplon 10 and 20 mg on memory and actual driving performance Hum Psychopharmacol 13 1998 S98 S107
11. A. Vermeeren, W.J. Riedel, and M.P. van Boxtel et al. Differential residual effects of zaleplon and zopiclone on actual driving: a comparison with a low dose of alcohol Sleep 25 2002 224 231
12. T.R. Leufkens, J.S. Lund, and A. Vermeeren Highway driving performance and cognitive functioning the morning after bedtime and middle-of-the-night use of gaboxadol, zopiclone and zolpidem J Sleep Res 18 2009 387 396
13. T.R. Leufkens, and A. Vermeeren Highway driving in the elderly the morning after bedtime use of hypnotics: a comparison between temazepam 20 mg, zopiclone 7.5 mg, and placebo J Clin Psychopharmacol 29 2009 432 438
14. J. Gaillot, D. Heusse, and G.W. Hougton et al. Pharmacokinetics and metabolism of zopiclone Pharmacology 27 Suppl 2 1983 76 91
15. J. Gaillot, Y. Le Roux, G.W. Houghton, and J.F. Dreyfus Critical factors for pharmacokinetics of zopiclone in the elderly and in patients with liver and renal insufficiency Sleep 10 Suppl 1 1987 7 21
16. D.J. Greenblatt, J.S. Harmatz, and L.L. von Moltke et al. Age and gender effects on the pharmacokinetics and pharmacodynamics of triazolam, a cytochrome P450 3A substrate Clin Pharmacol Ther 76 2004 467 479
17. M.M. Cotreau, L.L. von Moltke, and D.J. Greenblatt The influence of age and sex on the clearance of cytochrome P450 3A substrates Clin Pharmacokinet 44 2005 33 60
18. J.F. O'Hanlon Driving performance under the influence of drugs: rationale for, and application of, a new test Br J Clin Pharmacol 18 Suppl 1 1984 121s 129s
19. J.F. O'Hanlon Zopiclone's residual effects on psychomotor and information processing skills involved in complex tasks such as car driving: a critical review Eur Psychiatry 10 Suppl 3 1995 137s 143s
20. J.F. O'Hanlon, and J.G. Ramaekers Antihistamine effects on actual driving performance in a standard test: a summary of Dutch experience, 1989-94 Allergy 50 1995 234 242
21. J.G. Ramaekers Antidepressants and driver impairment: empirical evidence from a standard on-the-road test J Clin Psychiatry 64 2003 20 29
22. A. Vermeeren Residual effects of hypnotics: epidemiology and clinical implications CNS Drugs 18 2004 297 328
23. J.C. Verster, D.S. Veldhuijzen, and E.R. Volkerts Is it safe to drive a car when treated with anxiolytics? Evidence from on-the-road driving studies during normal traffic Curr Psychiatry Rev 1 2005 215 225
24. T.R. Leufkens, A. Vermeeren, and B.E. Smink et al. Cognitive, psychomotor and actual driving performance in healthy volunteers after immediate and extended release formulations of alprazolam 1 mg Psychopharmacology (Berl) 191 2007 951 959
25. J.W. Louwerens, A.B. Gloerich, and G. de Vries et al. The relationship between drivers' blood alcohol concentration (BAC) and actual driving performance during high speed travel Alcohol, Drugs Traffic Saf T86 1987 183 186
26. R.F. Borkenstein, F.R. Crowther, and R.P. Shumate et al. The role of drinking driver in traffic accidents: the Grand Rapids Study Blutalkohol 11 Suppl 1 1974 1 131
27. K. Owens, and J.G. Ramaekers Drugs, driving, and models to measure driving impairment J.C. Verster, S.R. Pandi-Perumal, J.G. Ramaekers, J.J. De Gier, Drugs, Driving and Traffic Safety 2009 Birkhäuser Verlag AG Basel, Switzerland 43 58
28. W.P. Dunlap, J.M. Cortina, J.B. Vaslow, and M.J. Burke Meta-analysis of experiments with matched groups or repeated measures designs Psychol Methods 1 1996 170 177
29. H.P. Krüger, and M. Vollrath The alcohol-related accident risk in Germany: procedure, methods and results Accid Anal Prev 36 2004 125 133
30. Wolschrijn H, De Gier JJ, De Smet PAGM. Drugs and Driving: A New Categorization System for Drugs Affecting Psychomotor Performance. Maastricht, the Netherlands: Institute for Drugs, Safety and Behaviour, University of Limburg; 1991:24.
31. M.L. Bocca, F. Le Doze, and O. Etard et al. Residual effect of zolpidem 10 mg and zopiclone 7.5 mg versus flunitrazepam 1 mg and placebo on driving performance and ocular saccades Psychopharmacology (Berl) 143 1999 373 379
32. C. Berthelon, M.L. Bocca, P. Denise, and A. Pottier Do zopiclone, zolpidem and flunitrazepam have residual effects on simulated task of collision anticipation? J Psychopharmacol 17 2003 324 331
33. C. Berthelon, A. de Longcamp, A. Coquerel, and P. Denise Residual effects of zolpidem, zopiclone and flunitrazepam on the processing of visual information in driving context Rev Eur Psychol Appliquée 58 2008 111 116
34. S. Dubois, M. Bedard, and B. Weaver The impact of benzodiazepines on safe driving Traffic Inj Prev 9 2008 404 413
35. J.C. Verster, and T. Roth Gender differences in highway driving performance after administration of sleep medication: a review of the literature Traffic Inj Prev 13 2012 286 292
36. D.J. Greenblatt, J.S. Harmatz, and L.L. von Moltke et al. Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex-dependent differences J Pharmacol Exp Ther 293 2000 435 443
37. G.D. Anderson Gender differences in pharmacological response Int Rev Neurobiol 83 2008 1 10
38. A. Vermeeren, J.G. Ramaekers, and J.F. O'Hanlon Effects of emedastine and cetirizine, alone and with alcohol, on actual driving of males and females J Psychopharmacol 16 2002 57 64
39. J.B. Schwartz The influence of sex on pharmacokinetics Clin Pharmacokinet 42 2003 107 121
40. D.J. Greenblatt, and L.L. von Moltke Gender has a small but statistically significant effect on clearance of CYP3A substrate drugs J Clin Pharmacol 48 2008 1350 1355
41. D.J. Greenblatt, and M.D. Allen Toxicity of nitrazepam in the elderly: a report from the Boston Collaborative Drug Surveillance Program. 1978 Br J Clin Pharmacol 58 2004 S844 S850
42. E.F. Vuurman, and R. Giorgetti Effects of low and moderate doses of alcohol on actual driving in young novice drivers compared to experienced drivers Intern Rep 2009
43. A.N. Bateson Basic pharmacologic mechanisms involved in benzodiazepine tolerance and withdrawal Curr Pharm Des 8 2002 5 21
44. I. Neutel Benzodiazepine-related traffic accidents in young and elderly drivers Hum Psychopharmacol 13 1998 S115 S123
45. A. Bond, and M. Lader The use of analogue scales in rating subjective feelings Br J Med Psychol 47 1974 211 218
46. D.J. Greenblatt, and G.K. Zammit Pharmacokinetic evaluation of eszopiclone: clinical and therapeutic implications Expert Opin Drug Metab Toxicol 8 2012 1609 1618