Residual effects of zopiclone 7.5?mg on highway driving performance in insomnia patients and healthy controls: a placebo controlled crossover study
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- 作者：T. R. M. Leufkens (1)
J. G. Ramaekers (2)
A. W. de Weerd (3)
W. J. Riedel (2)
A. Vermeeren (2) - 关键词：Zopiclone ; Hypnotics ; Residual effects ; Insomnia ; On ; the ; road driving
- 刊名：Psychopharmacology
- 出版年：2014
- 出版时间：July 2014
- 年：2014
- 卷：231
- 期：14
- 页码：2785-2798
- 全文大小：335 KB
- 参考文献：1. Akerstedt T, Gillberg M (1990) Subjective and objective sleepiness in the active individual. Int J Neurosci 52:29-7 <a class="external" href="http://dx.doi.org/10.3109/00207459008994241" target="_blank" title="It opens in new window">CrossRefa>
2. Association AP (1994) DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, 4th edn. American Psychiatric, Washington DC
3. Barbone F, McMahon AD, Davey PG et al (1998) Association of road-traffic accidents with benzodiazepine use. Lancet 352:1331-336 <a class="external" href="http://dx.doi.org/10.1016/S0140-6736(98)04087-2" target="_blank" title="It opens in new window">CrossRefa>
4. Beck AT, Ward CH, Mendelson M et al (1961) An inventory for measuring depression. Arch Gen Psychiatry 4:561-71 <a class="external" href="http://dx.doi.org/10.1001/archpsyc.1961.01710120031004" target="_blank" title="It opens in new window">CrossRefa>
5. Bocca ML, Sullivan M, Lelong-Boulouard V et al (2011) Zolpidem and zopiclone impair similarly monotonous driving performance after single nighttime intake in aged subjects. Psychopharmacol (Berl) 214:699-06 <a class="external" href="http://dx.doi.org/10.1007/s00213-010-2075-5" target="_blank" title="It opens in new window">CrossRefa>
6. Bond A, Lader M (1974) The use of analogue scales in rating subjective feelings. Br J Med Psychol 47:211-18 <a class="external" href="http://dx.doi.org/10.1111/j.2044-8341.1974.tb02285.x" target="_blank" title="It opens in new window">CrossRefa>
7. Bosker WM, Kuypers KPC, Conen S et al (2012) MDMA (ecstasy) effects on actual driving performance before and after sleep deprivation, as function of dose and concentration in blood and oral fluid. Psychopharmacol (Berl) 222:367-76 <a class="external" href="http://dx.doi.org/10.1007/s00213-011-2497-8" target="_blank" title="It opens in new window">CrossRefa>
8. Brookhuis KA, De Waard D, Mulder LJ (1994) Measuring driving performance by car-following in traffic. Ergonomics 37:427-34 <a class="external" href="http://dx.doi.org/10.1080/00140139408963661" target="_blank" title="It opens in new window">CrossRefa>
9. Buysse DJ, Reynolds CF 3rd, Monk TH et al (1989) The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 28:193-13 <a class="external" href="http://dx.doi.org/10.1016/0165-1781(89)90047-4" target="_blank" title="It opens in new window">CrossRefa>
10. Curran HV, Collins R, Fletcher S et al (2003) Older adults and withdrawal from benzodiazepine hypnotics in general practice: effects on cognitive function, sleep, mood and quality of life. Psychol Med 33:1223-237 <a class="external" href="http://dx.doi.org/10.1017/S0033291703008213" target="_blank" title="It opens in new window">CrossRefa>
11. Derogatis LR (1983) The SCL-90-R: administration, scoring and procedures manual II. Baltimore Clinical Psychometric Research, Baltimore
12. Dinges DF, Powell JW (1985) Microcomputer analyses of performance on a portable, simple visual RT task during sustained operations. Behav Res Methods Instrum Comput 17:652-55 <a class="external" href="http://dx.doi.org/10.3758/BF03200977" target="_blank" title="It opens in new window">CrossRefa>
13. Drake CL, Roehrs T, Roth T (2003) Insomnia causes, consequences, and therapeutics: an overview. Depress Anxiety 18:163-6 <a class="external" href="http://dx.doi.org/10.1002/da.10151" target="_blank" title="It opens in new window">CrossRefa>
14. Gillin JC, Spinweber CL, Johnson LC (1989) Rebound insomnia: a critical review. J Clin Psychopharmacol 9:161-71 <a class="external" href="http://dx.doi.org/10.1097/00004714-198906000-00002" target="_blank" title="It opens in new window">CrossRefa>
15. Glass J, Lanctot KL, Herrmann N et al (2005) Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. Br Med J 331:1169-175 <a class="external" href="http://dx.doi.org/10.1136/bmj.38623.768588.47" target="_blank" title="It opens in new window">CrossRefa>
16. Hemmelgarn B, Suissa S, Huang A et al (1997) Benzodiazepine use and the risk of motor vehicle crash in the elderly. J Am Med Assoc 278:27-1 <a class="external" href="http://dx.doi.org/10.1001/jama.1997.03550010041037" target="_blank" title="It opens in new window">CrossRefa>
17. Howard ME, Jackson ML, Kennedy GA et al (2007) The interactive effects of extended wakefulness and low-dose alcohol on simulated driving and vigilance. Sleep 30:1334-340
18. Iber C, Ancoli-Israel S, Chesson A, Quan SF (2007) The AASM manual for the scoring of sleep ans associated events: rules, terminology and technical specifications. AASM, Westchester, Ill
19. Jex HR, McDonnell JD, Phatak A V (1966) A “critical-tracking task for man-machine research related to the operator’s effective delay time. I. Theory and experiments with a first-order divergent controlled element. NASA CR-616. NASA Contract Rep NASA CR 1-05
20. Jongen S, Vuurman E, Ramaekers JG, Vermeeren A (2014) Alcohol calibration of tests measuring skills related to car driving. Psychopharmacology. doi:
21. Kales A, Manfredi RL, Vgontzas AN et al (1990) Rebound insomnia after only brief and intermittent use of rapidly eliminated benzodiazepines. Clin Pharmacol Ther 49:468-76 <a class="external" href="http://dx.doi.org/10.1038/clpt.1991.55" target="_blank" title="It opens in new window">CrossRefa>
22. Lader M (1997) Zopiclone: is there any dependence and abuse potential? J Neurol 244:S18–S22 <a class="external" href="http://dx.doi.org/10.1007/BF03160567" target="_blank" title="It opens in new window">CrossRefa>
23. Leufkens TRM, Vermeeren A (2009) 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 29:432-38 <a class="external" href="http://dx.doi.org/10.1097/JCP.0b013e3181b57b43" target="_blank" title="It opens in new window">CrossRefa>
24. Leufkens TRM, Vermeeren A (2014) Zopiclone’s residual effects on actual driving performance in a standardized test: a pooled analysis of age and gender effects in four placebo controlled studies. Clin Ther 36:141-50 <a class="external" href="http://dx.doi.org/10.1016/j.clinthera.2013.11.005" target="_blank" title="It opens in new window">CrossRefa>
25. Leufkens TRM, Lund JS, Vermeeren A (2009) Highway driving performance and cognitive functioning the morning after bedtime and middle-of-the-night use of gaboxadol, zopiclone and zolpidem. J Sleep Res 18:387-96 <a class="external" href="http://dx.doi.org/10.1111/j.1365-2869.2009.00746.x" target="_blank" title="It opens in new window">CrossRefa>
26. Leufkens TRM, Ramaekers JG, de Weerd AW, Riedel WJ, Vermeeren A (2014) On-the-road driving performance and driving related skills in older untreated insomnia patients and chronic users of hypnotics. Psychopharmacology. doi:
27. Lim J, Dinges DF (2008) Sleep deprivation and vigilant attention. Ann N Y Acad Sci 1129:305-22 <a class="external" href="http://dx.doi.org/10.1196/annals.1417.002" target="_blank" title="It opens in new window">CrossRefa>
28. Logan GD, Cowan WB, Davis KA (1984) On the ability to inhibit simple and choice reaction time responses: a model and a method. J Exp Psychol Hum Percept Perform 10:276-91 <a class="external" href="http://dx.doi.org/10.1037/0096-1523.10.2.276" target="_blank" title="It opens in new window">CrossRefa>
29. Louwerens JW, Gloerich ABM, de Vries G et al (1987) The relationship between drivers-blood alcohol concentration (BAC) and actual driving performance during high speed travel. Alcohol Drugs Traffic Saf T86:183-86
30. Moskowitz H (1973) Proceedings: psychological tests and drugs. Pharmakopsychiatr Neuropsychopharmakol 6:114-26 <a class="external" href="http://dx.doi.org/10.1055/s-0028-1094374" target="_blank" title="It opens in new window">CrossRefa>
31. Mulder-Hajonides van der Meulen WREH (1981) Measurement of subjective sleep quality. Elsevier, Amsterdam
32. Neutel I (1998) Benzodiazepine-related traffic accidents in young and elderly drivers. Hum Psychopharm 13:S115–S123 <a class="external" href="http://dx.doi.org/10.1002/(SICI)1099-1077(1998110)13:2+<S115::AID-HUP56>3.0.CO;2-O" target="_blank" title="It opens in new window">CrossRefa>
33. O’Hanlon JF (1984) Driving performance under the influence of drugs: rationale for, and application of, a new test. Br J Clin Pharmacol 18:121s-29s <a class="external" href="http://dx.doi.org/10.1111/j.1365-2125.1984.tb02590.x" target="_blank" title="It opens in new window">CrossRefa>
34. Pétursson H (1994) The benzodiazepine withdrawal syndrome. Addiction 89:1455-459 <a class="external" href="http://dx.doi.org/10.1111/j.1360-0443.1994.tb03743.x" target="_blank" title="It opens in new window">CrossRefa>
35. Ramaekers JG (2011) Effects of medicinal drugs on actual and simulated driving. Deliverable 1.2.2., 2011. DRUID (Driving under the Influence of Drugs, Alcohol and Medicines). 6th Framework programme. Available via <a href="http://www.druid-project.eu/" class="a-plus-plus">http://www.druid-project.eu/a>. Accessed 5 Dec 2013
36. Ramaekers JG, O’Hanlon JF (1994) Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing. Eur J Clin Pharmacol 47:261-66 <a class="external" href="http://dx.doi.org/10.1007/BF02570506" target="_blank" title="It opens in new window">CrossRefa>
37. Rey A (1964) L’examen clinique en psychologie. Presses Universitaires de France, Paris
38. Smets EM, Garssen B, Bonke B, De Haes JC (1995) The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 39:315-25 <a class="external" href="http://dx.doi.org/10.1016/0022-3999(94)00125-O" target="_blank" title="It opens in new window">CrossRefa>
39. Spielberger CD, Gorsuch RL, Lushene RE et al (1983) Manual for the State-Trait Anxiety Inventory (Form Y). Consulting Psychologists, Palo Alto
40. Staner L, Ertlé S, Boeijinga P et al (2005) Next day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring. Psychopharmacol (Berl) 181:790-98 <a class="external" href="http://dx.doi.org/10.1007/s00213-005-0082-8" target="_blank" title="It opens in new window">CrossRefa>
41. Van Diest R, Milius H, Markusse R, Snel J (1989) The Sleep-Wake Experience List. Tijdschr Soc Gezondheidsz 67:343-47
42. Vermeeren A (2004) Residual effects of hypnotics: epidemiology and clinical implications. CNS Drugs 18:297-28 <a class="external" href="http://dx.doi.org/10.2165/00023210-200418050-00003" target="_blank" title="It opens in new window">CrossRefa>
43. Vermeeren A, O’Hanlon JF, Declerck AC, Kho L (1995) Acute effects of zolpidem and flunitrazepam on sleep, memory and driving performance, compared to those of partial sleep deprivation and placebo. Acta Theriol 21:47-4
44. Vermeeren A, Danjou PE, O’Hanlon JF (1998) 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:S98–S107 <a class="external" href="http://dx.doi.org/10.1002/(SICI)1099-1077(1998110)13:2+<S98::AID-HUP54>3.0.CO;2-1" target="_blank" title="It opens in new window">CrossRefa>
45. Vermeeren A, Ramaekers JG, O’Hanlon JF (2002a) Effects of emedastine and cetirizine, alone and with alcohol, on actual driving of males and females. J Psychopharmacol 16:57-4 <a class="external" href="http://dx.doi.org/10.1177/026988110201600104" target="_blank" title="It opens in new window">CrossRefa>
46. Vermeeren A, Riedel WJ, van Boxtel MP et al (2002b) Differential residual effects of zaleplon and zopiclone on actual driving: a comparison with a low dose of alcohol. Sleep 25:224-31
47. Verster JC, Volkerts ER, Schreuder AH et al (2002) Residual effects of middle-of-the-night administration of zaleplon and zolpidem on driving ability, memory functions, and psychomotor performance. J Clin Psychopharmacol 22:576-83 <a class="external" href="http://dx.doi.org/10.1097/00004714-200212000-00007" target="_blank" title="It opens in new window">CrossRefa>
48. Volkerts ER, Louwerens JW, Gloerich ABM, Brookhuis KJ, O'Hanlon JF (1984) Zopiclone's residual effect upon actual driving performance versus those of nitrazepam and flunitrazepam. Tech Rep VK-84-10. Traffic Research Centre, University of Groningen
49. Zijlstra FRH (1993) Efficiency in work behavior. A design approach for modern tools. Delft University of Technology - 作者单位：T. R. M. Leufkens (1)
J. G. Ramaekers (2)
A. W. de Weerd (3)
W. J. Riedel (2)
A. Vermeeren (2)
1. Division Information and Cognition, Department of Brain, Body and Behavior, Philips Group Innovation–Research, High Tech Campus 34, 5656, AE, Eindhoven, The Netherlands
2. Experimental Psychopharmacology Unit, Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands
3. Department of Clinical Neurophysiology and Sleep Centre SEIN, Zwolle, The Netherlands - ISSN：1432-2072
文摘
Rationale Residual effects of hypnotics on driving performance have been mainly determined in studies using a standardized driving test with healthy good sleepers. Responses to effects may differ, however, between insomniacs and healthy volunteers due to the underlying sleep disorder. In addition, a majority of insomniacs uses hypnotics chronically resulting in the development of tolerance to impairing effects. Impaired driving performance in healthy volunteers may then be an overestimation of the actual effects in insomniacs. Objectives The present study aims to compare the residual effects of zopiclone 7.5?mg on on-the-road driving performance of 16 middle-aged insomniacs chronically using hypnotics (chronic users), 16 middle-aged insomniacs not or infrequently using hypnotics (infrequent users), and 16 healthy, age matched, good sleepers (controls). Methods The study was conducted according to a 3?×- double-blind, placebo controlled crossover design, with three groups and two treatment conditions. Treatments were single oral doses of zopiclone 7.5?mg and placebo administered at bedtime (2330?hours). Between 10 and 11?h after administration subjects performed a standardized highway driving test. Results Zopiclone 7.5?mg significantly impaired on-the-road driving performance in both insomnia groups and healthy controls. The magnitude of impairment was significantly less in the chronic users group as compared with the controls. Conclusions The smaller magnitude of effects suggests that investigating residual effects of hypnotics in healthy volunteers may yield a minor overestimation of the actual effects in insomnia patients.