A double-blind, placebo- and flurazepam-controlled investigation of the residual psychomotor and cognitive effects of modified release zolpidem in young healthy volunteers

Journal of Clinical Psychopharmacology

Volumn 26, Issue 3, 2006, Pages 284-289

  Blin, Olivier ^a,c   Micallef, Joëlle ^a   Audebert, Christine ^a   Legangneux, Eric ^b  

^a Service de Pharmacologie Médicale et Pharmacovigilance   (France)

^b Sanofi Synthelabo   (United States)

^c TIMONE HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

FLURAZEPAM; HYPNOTIC AGENT; PLACEBO; ZOLPIDEM; ZOLPIDEM TARTRATE;

ADULT; AGITATION; ALERTNESS; ARTICLE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICAL FLICKER FUSION; CROSSOVER PROCEDURE; DIGIT SYMBOL SUBSTITUTION TEST; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; ELECTROSPRAY MASS SPECTROMETRY; ERYTHEMA; EYE TRACKING; FEMALE; HUMAN; HUMAN EXPERIMENT; INSOMNIA; LEEDS SLEEP EVALUATION QUESTIONNAIRE; LIQUID CHROMATOGRAPHY; MALE; MEMORY DISORDER; NEUROPSYCHOLOGICAL TEST; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PSYCHOMOTOR PERFORMANCE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RESPONSE TIME; SIDE EFFECT; SINGLE DRUG DOSE; SLEEP; SLOW RELEASE FORMULATION; SOMNOLENCE; VISUAL ANALOG SCALE; VOLUNTEER; WORD RECOGNITION;

ADULT; COGNITION; DOUBLE-BLIND METHOD; FEMALE; FLICKER FUSION; FLURAZEPAM; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MENTAL RECALL; PSYCHOMOTOR PERFORMANCE; PYRIDINES; REACTION TIME;

EID: 33744491280     PISSN: 02710749     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.jcp.0000218985.07425.d9     Document Type: Article

References (42)

1. Greenblatt DJ. Benzodiazepine hypnotics: sorting the pharmacokinetic facts. J Cin Psychiatry. 1981;52 suppl:4-10.
2. Vgontzas AN, Kales A, Bixler EO. Benzodiazepine side effects: role of pharmacokinetics and pharmacodynamics. Pharmacology. 1995;51: 205-223.
3. Hindmarch I, Fairweather DB. Assessing the residual effects of hypnotics. Acta Psychiatr Belg. 1994;94:88-95.
4. Barbone F, McMahon AD, Davey PG, et al. Association of road-traffic accidents with benzodiazepine use. Lancet. 1998;352:1331-1336.
5. Vermeeren A. Residual effects of hypnotics: epidemiology and clinical implications. CNS Drugs. 2004;18:297-328.
6. Johnson LC, Chernik DA. Sedative-hypnotics and human performance. Psychopharmacology. 1982;76:101-113.
7. Koelega HS. Benzodiazepines and vigilance performance: a review. Psychopharmacology. 1989;98:145-156.
8. Holm KJ, Goa KL. Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs. 2000;59:865-889.
9. Salvà P, Costa J. Clinical pharmacokinetics and pharmacodynamics of zolpidem. Therapeutic implications. Clin Pharmacokinet. 1995;29: 142-153.
10. Pichard L, Gillet G, Bonfils C, et al. Oxidative metabolism of zolpidem by human liver cytochrome P450S. Drug Metab Dispos. 1995;23: 1253-1262.
11. Hesse L, Von-Moltke L, Greenblatt D. Clinically important drug interactions with zopiclone, zolpidem and zaleplon. CNS Drugs. 2003; 17:513-532.
12. Von Moltke LL, Greenblatt DJ, Granda BW, et al. Zolpidem metabolism in vitro: responsible cytochromes, chemical inhibitors, and in vivo correlations. Br J Clin Pharmacol. 1999;48:89-97.
13. Greenblatt DJ, Harmatz JS, von Moltke LL, et al. Comparative kinetics and dynamics of zaleplon, zolpidem, and placebo. Clin Pharmacol Ther. 1998;64:553-561.
14. Greenblatt DJ, Harmatz JS, von Moltke LL, et al. Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex-dependent differences. J Pharmacol Exp Ther. 2000; 293:435-443.
15. Declerck AC, Bisserbe JL. Short-term safety profile of zolpidem: objective measures of cognitive effects. Eur Psychiatry. 1997;12(suppl 1): 15S-20S.
16. Besset A, Tafti M, Villemin E, et al. Effects of zolpidem on the architecture and cyclical structure of sleep in poor sleepers. Drugs Exp Clin Res. 1995;21:161-169.
17. Weinling E, Andre F, Dubruc C, et al. Pharmacokinetic profile of a new modified-release formulation of zolpidem designed to improve sleep maintenance. Sleep. 2004;27(abstr suppl):271.
18. Hindmarch I, Legangneux E, Stanley N. A randomized double-blind placebo-controlled 10-way cross-over study shows that a new zolpidem modified-release formulation improves sleep maintenance compared to standard zolpidem. Sleep. 2004;27(abstr suppl):55.
19. Hindmarch I. A repeated dose comparison of three benzodiazepine derivatives (nitrazepam, flurazepam and flunitrazepam) on subjective assessment of sleep and measures of psychomotor performance the morning following night-time medication. Acta Psychiatr Scand. 1977; 56:373-381.
20. Greenblatt DJ, Divoll M, Harmatz JS, et al. Kinetics and clinical effects of flurazepam in young and elderly noninsomniacs. Clin Pharmacol Ther. 1981;30:475-486.
21. Curran S. Critical Flicker Fusion techniques in psychopharmacology. In: Hindmarch I, Stonier PD, eds. Human Psychopharmacology: Measures and Methods, Vol 3. Chichester: John Wiley and Sons; 1990.
22. Sherwood N, Kerr JS. The reliability, validity and pharmacosensitivity of 4 psychomotor tests. In: Hindmarch I, Stonier PD, eds. Human Psychopharmacology: Measures and Methods, Vol 4. Chichester: John Wiley and Sons; 1993.
23. Baddeley AD. Working Memory. Oxford: Oxford University Press; 1986.
24. Parkin C, Fairweather DB, Shamsi Z, et al. The effects of cigarette smoking on overnight performance. Psychopharmacology. 1998;136: 172-178.
25. Weschler D. Adult Intelligence Scale (Revised). New York: The Psychological Corp; 1981.
26. Hindmarch I. Relevant psychometric tests for antidepressants and anxiolytics. Int Clin Psychopharmacol. 1994;9(suppl 1):27-33.
27. Woodworth R, Schlosberg H. Human Experimental Psychology. London: Methuen; 1958.
28. Smith JM, Misiak H. Critical Flicker Fusion Frequency (CFF) and psychotropic drugs in human subjects: a review. Psychopharmacology. 1976;47:175-182.
29. Hindmarch I. 1-4 Benzodiazepine temazepam (K3917), its effect on some psychological parameters of sleep and behaviour. Arzneim Forcsh. 1975;25:1836-1839.
30. Hindmarch I. Critical Flicker Fusion Frequency (CFF): the effects of psychotropic compounds. Pharmacopsychiatria. 1982;15(suppl 1): 44-48.
31. Fairweather DB, Dal Pozzo C, Kerr JS, et al. Citalopram compared to dothiepin and placebo: effects on cognitive function and psychomotor performance. Hum Psychopharmacol. 1997;12:119-126.
32. Baselt RC. Drug Effects on Psychomotor Performance. Biomedical Publications: Foster City, CA; 2001 [ISBN 0-9626523-4-2].
33. Baddeley AD, Hitch G. Working memory. In: Bower GA, eds. Recent Advances in Learning and Motivation (Vol 8). New York: Academic Press; 1974.
34. Paivio A, Yuile JC, Madigan S. Concreteness, imagery and meaningfulness values for 925 nouns. J Exp Psychol Monogr Suppl. 1968;76: 1-25.
35. Hindmarch I, Subhan Z, Stoker MJ. Comparison of the effects of zimelidine and amitriptyline on car driving and psychomotor performance. Acta Psychiatr Scand. 1983;308:141-146.
36. Hindmarch I. Three antidepressants (amitriptyline, dothiepin and fluoxetine) with and without alcohol, compared with placebo on tests of psychomotor ability related to car driving. Hum Psychopharmacol. 1987;2:177-183.
37. Parrott AC. Performance tests in human psychopharmacology (3): construct validity and test interpretation. Hum Psychopharmacol. 1991; 6:197-207.
38. Lezak MD. Neuropsychological Assessment. 3rd ed. New York: Oxford University Press; 1995.
39. Parrott AC, Hindmarch I. Factor analysis of a sleep evaluation questionnaire. Psychol Med. 1978;8:325-359.
40. Bond A, Lader M. The use of analogue scales in rat in subjective feelings. Br J Med Psychol. 1974;47:211-218.
41. Salkind MR, Silverstone T. A clinical and psychometric evaluation of flurazepam. Br J Clin Pharmacol. 1975;2:223-226.
42. Verster JC, Volkerts ER, Schreuder AH, et al. Residual effects of middle-of-the-night administration of zaleplon and zolpidem on driving ability, memory functions, and psychomotor performance. J Clin Psychopharmacol. 2002;22:576-583.