Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-11-23T03:39:46.593Z Has data issue: false hasContentIssue false
  • English
  • Français

Short-term safety profile of zolpidem: objective measures of cognitive effects

Published online by Cambridge University Press:  16 April 2020

AC DeClerk  and
JC Bisserbe
AC DeClerk
Affiliation:
Centre for Sleep/Wake Disorders. Kempenhaeghe, Sterkselseweg 65, 5591 Ve Heeze. The Netherhnds
JC Bisserbe
Affiliation:
Inserm U302, Hôpital de la Salpetriere, Pavillon Clerambault. 47 Blvd de LHôpital, 75013Paris, France
Get access

Abstract

The potential effects of zolpidem, a non-benzodiazepine hypnotic, on cognitive and psychomotor functions have been explored in more than 30 placebo controlled studies, and in many cases in comparison with benzodiazepine reference hypnotics (ie flunitrazepam, nitrazepam, triazolam). Daytime impact of drug administration on alertness has been studied with the Multiple Sleep Latency Test, and no significant clinical impairment has been found after zolpidem 5 to 10 mg, unlike benzodiazepines. Evaluation of the effects of zolpidem on attention and psychomotor skills (critical flicker fusion threshold, substitution or copying tests, choice reaction times or driving tests, etc) indicate that zolpidem at recommended doses (5 mg in elderly and 10 mg in adults) is unlikely to produce significant detrimental residual effects on daytime vigilance, concentration and coordination performances on the morning after intake. In accordance with its pharmacokinetic and pharmacodynamic properties, the effects on zolpidem on memory functions were limited to the first hours after administration and no significant difference was observed between zolpidem (5–10 mg) and placebo 6 hours after administration; longer memory impairment was observed with flunitrazepam or triazolam. Various groups of subjects were included in these studies, both young adults and elderly subjects, healthy volunteers and insomniac patients, and duration of treatment varied between one single dose and 28 days of repeated intake. In conclusion, experimental evidence demonstrates a satisfactory safety profile of zolpidem (5–10 mg) on daytime cognitive functions as compared to other hypnotics.

Keywords

zolpidemhypnoticcognitive functionsresidual effectssafety
Type
Research Article
Information
European Psychiatry , Volume 12 , Issue S1 , 1997 , pp. 15S - 20S
Copyright
Copyright © Elsevier, Paris 1997

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Balkin, TJ, O'Donnel, VM, Wesensten, N, McCann, U, Belenky, G. Comparison of the daytime sleep and performance effects of zolpidem versus triazolam Psychopharmacology 107 1992 8388CrossRefGoogle ScholarPubMed
Bensimon, C, Foret, J, Warot, D, Lacomblez, L, Thiercelin, JF, Simon, P. Daytime wakefulness following a bed time oral dose of zolpidem 20 mg, flunitrazepam 2 mg and placebo Br J Clin Pharmacol 30 1990 463469CrossRefGoogle Scholar
Berlin, I, Warot, D, Hergueta, T, Molinier, P, Pagot, C, Puech, A. Comparison of the effects of zolpidem and tiazolam on memory fuctions, and psychomotor performances, and postural sway in healthy subjects J Clin Psychophamacol 13 2 1993 100106Google Scholar
Besset, A, Tafti, M, Billiard, MEffects of zolpidem on sleep architecture and daytime psychomotor skills in poor sleepersAbstract books, 10th Congress of the European Sleep Research Society Strasbourg 20–25 May 1990 138Google Scholar
Borbély, AA, Youmbi-Balderer, G, Jaggi-Schwarz, KZolpidem (10 mg and 20 mg): hypnotic action and residual effects after a single bedtime doseSauvanet, JP, Lager, SZ, Morselli, PLImidazopyridines in sleep disorders: a novel experimental and therapeutic approach (LERS Monograph series vol. 6) 1988 Raven Press New York205210Google Scholar
DeJong, H, Jackson, J, Louwerens, J. A double-blind study on the residual effect on the memory of the imidazopyridine zolpidem compared to placebo Book of abstracts WFSRS, Cannes, France, 21–25 Sept. 1991 Sleep Res 20A 1991 124Google Scholar
Dujardin, K, Derambure, P, Guieu, JD, Borderies, P, Leconte, P. Effects of a single dose of zolpidem 10 mg comparatively to placebo and 2 mg of flunitrazepam on cognitive process the day following the intake Book of abstracts WFSRS, Cannes, France, 21–25 Sept. 1991 Sleep Res 20A 1992 126Google Scholar
Fairweather, DB, Kerr, JS, Hindmarch, I. The effects of acute and repeated doses of zolpidem on subjective sleep, psychomotor performance and cognitive function in elderly volunteers Eur J Clin Pharmacol 43 1992 597601CrossRefGoogle ScholarPubMed
Hoffmann, G, Lebon, O, Lebuck, R. Effects of zolpidem on polysomnography and daytime performance in psychophysiological insomnia Book of abstracts WFSRS, Cannes, France, 21–25 Sept. 1991 Sleep Res 20A 1991 330Google Scholar
Jackson, JL, Louwerens, JW, Cnossen, F, de Jong, HTP. Testing the effects of the imidazopyridine zolpidem on memory: an ecologically valid approach Human Psychopharmacol 7 1992 325330CrossRefGoogle Scholar
Jackson, JL, Louwerens, JW, Cnossen, F, de Jong, HTP. Testing the effects of hypnotics on memory via the telephone: fact or fiction Psychopharmacology 111 1993 127133CrossRefGoogle ScholarPubMed
Kryger, MH, Steljes, D, Pouliot, Z, Neufeld, H, Odynski, T. Subjective versus objective evaluation of hypnotic efficacy: experience with zolpidem Sleep 14 1991 399407CrossRefGoogle ScholarPubMed
Kurtz, D, Baas, V, Rumbach, LEffets de l'administration répétée de zolpidem 10 mg sur le sommeil et la vigilance diurne chez des mauvais dormeurs In: Strasbourg, 20–25 May 1990 Symposium STILNOX 1st Imidazopyridine. 10th Congress of the European Sleep Research Society 1991 ADIS Aukland143151Google Scholar
Lorizio, A, Terzano, M, Parrino, LControlled study of the efficacy and safety of two oral doses of zolpidem (10 and 20 mg) In: Sauvanet, JP, Lager, SZ, Morselli, PImidazopyridines in sleep disorders: a novel experimental and therapeutic approach (LERS Monograph series; vol 6) 1988 Raven Press New York385Google Scholar
Lund, R, Rüther, E, Wober Hippius, HEffects of zolpidem (10 and 20 mg), lormetazepam, triazolam and placebo on night sleep and residual effects during the day In: Sauvanet, JP, Lager, SZ, Morselli, PLImidazopyridines in sleep disorders: a novel experimental and therapeutic approach (LERS Monograph series vol 6) 1988 Raven Press New York193203Google Scholar
Merlotti, L, Roehrs, T, Koshorek, G, Zorick, F, Lamphere, J, Roth, T. The dose effects of zolpidem on the sleep of healthy normals J Clin Psychopharmacol 9 1989 914CrossRefGoogle ScholarPubMed
Monti, JM. Effect of zolpidem on sleep in insomniac patients Eur J Clin Pharmacol 36 1989 461466CrossRefGoogle ScholarPubMed
Morselli, PL, Larribaud, J, Guillet, Pet alDaytime residual effects of zolpidem: a review of avaible data In: Sauvanet, JP, Lager, SZ, Morselli, PLImidazopyridines in sleep disorders: a novel experimental and therapeutic approach (LERS Monograph series vol 6) 1988 Raven Press New York183191Google Scholar
Nicholson, A, Pascoe, P. Hypnotic activity of an imidazopyridine (zolpidem) Br J Pharmacol 21 1986 205211CrossRefGoogle Scholar
Poirrier, R, Lacroix, A, Scheldewaert, R, Jolie, A, Franck, G Effets à long terme de l'imidazopyridine hypnosélective zolpidem sur la polysomnographie nocturne et le test itératif d'endormissement en cas d'insomnie psycho-physiologique Brussels Annual Meeting of the Belgian Association for the study of sleep 1990Google Scholar
Richens, A, Mercer, AJ, Jones, DM, Griffiths, A, Marshall, RW. Effects of zolpidem on saccadic eye movements and psychomotor performance: a double-blind, placebo controlled study in healthy volunteers Br J Clin Pharmacol 36 1993 6165CrossRefGoogle ScholarPubMed
Scharf, MB, Mendels, J, Weiss, B, Therpy, M. Safety and efficacy of long-term zolpidem treatment in insomniac Sleep Res 19 1990 87Google Scholar
Scharf, MB, Mayleben, DW, Kaffeman, M, Krall, R, Ochs, R. Dose-response effects of zolpidem in normal geriatric subjects J Clin Psychiatry 52 1991 7783Google ScholarPubMed
Scharf, M, Schweitzer, P, Fleming, Jet alComparison of residual effects and efficacy of zolpidem, flurazepam and placebo in patients with chronic insomniaAbstracts of the 18th Collegium Internationale Neuro-Psychopharmacologicum Congress Nice, France 28 June–2 July 1992Google Scholar
Sicard, B, Trocherie, S, Moreau, Jet alAssessment of zolpidem's residual effects on alertness and psychomotor abilities in navy pilots and air force personnels Abstracts of the 11th European Congress on Sleep Researsch Helsinki, Finland 5–10 July 1992 J Sleep Res 1 1992 212 suppl 1Google Scholar
Terzano, MG, Lorizio, A, Farolfi, A, Borghi, C. Controlled study of the activity and safety of two oral doses (10 mg and 20 mg) of zolpidem versus placebo Abstracts of the 11th European Congress of the ESRS Finland 5–10 July 1992 J Sleep Res 1 1992 228 suppl 1Google Scholar
Vaucher, M, Osiek, C, Schulz, P. Influence of zolpidem, flunitrazepam and placebo on the cognitive and memory functions in healthy subjects Therapie 43 1988 163Google Scholar
Vermeeren, A, O'Hanlon, JF, Declerck, AC, Kho, L, Janssen, FHComparaison des effets résiduels du zolpidem, du flunitrazépam et de la privation de sommeil sur la mémoire, l'apprentissage et la conduite automobile In: Strasbourg, 20–25 May 1990 Symposium STILNOX 1st Imidazopyridine. 10th Congress of the European Sleep Research Society 1990 ADIS Aukland130132Google Scholar
Vogel, G, Thurmond, A, Macintosch, M, Clifton, T. The effects of zolpidem on transient insomnia Sleep Res 17 1988 67Google Scholar
Walsh, JK, Schweitzer, PK, Sugerman, JL, Muehlbach, MJ. Transient insomnia associated with a 3-hour phase advance of sleep time and treatment with zolpidem J Clin Psychopharmacol 10 1990 184189CrossRefGoogle ScholarPubMed
Wesensten, NJ, Balkin, TJ, O'Dennell, VM, Belenky, G. Somnogenically equivalents doses of zolpidem and triazolam II : effects on a measure of incendital memory Abstracts of the Association of Professional Sleep Societies Meeting Toronto, Canada, 14–19 June 1991 Sleep Res 20 1991 92Google Scholar
Submit a response

Comments

No Comments have been published for this article.