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Perfil de seguridad a corto plazo de zolpidem: medidas objetivas de efectos cognitivos

Published online by Cambridge University Press:  12 May 2020

A.C. DeClerk
Affiliation:
Centro de Trastornos del Sueño/Despertar, Kempenhaeghe, Holanda
J.C. Bisserbe
Affiliation:
Inserm U302, Hospital de la Salpêtrière, París, Francia
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Resumen

Los efectos potenciales de zolpidem, un hipnótico no benzodiacepínico, sobre las funciones cognitivas y psicomotoras han sido analizados en más de 30 estudios controlados por placebo, y en muchos casos se han comparado con los de hipnóticos benzodiacepínicos de referencia (es decir, flunitracepán, nitracepán y triazolam). El impacto de la administración de fármacos sobre la atención durante el día se ha analizado mediante la Prueba Múltiple de Latencia de Sueño, y no se ha observado ningún déficit clínico tras la toma de 5 a 10 mg de zolpidem, a diferencia de lo que ocurre con las benzodiacepinas. La evaluación del efecto de zolpidem sobre la atención y las capacidades psicomotoras (umbral de fusión crítica de parpadeo, pruebas de sustitución o copia, tiempos de reacción para elección, pruebas de conducción, etc.) indican que zolpidem en las dosis recomendadas (5 mg en ancianos y 10 mg en adultos) no parece producir efectos perjudiciales importantes sobre la vigilancia durante el día, y sobre la concentración y coordinación a la mañana siguiente de la ingesta. Respecto a sus propiedades farmacocinéticas y farmacodinámicas, los efectos de zolpidem sobre las funciones de la memoria se limitaron a las primeras horas después de la administración y no se observó ninguna diferencia significativa entre zolpidem (5-10 mg) y placebo 6 horas después de la administración; se detectaron más alteraciones de la memoria con flunitracepán y triazolam. En estos estudios participaron varios grupos de sujetos, adultos jóvenes y personas mayores, voluntarios sanos y pacientes insomnes, y la duración del tratamiento varió entre una sola dosis y 28 días de tratamiento. En conclusión, las pruebas experimentales demuestran que zolpidem tiene un perfil satisfactorio (5-10 mg) sobre las funciones cognitivas del día en comparación con otros hipnóticos.

Type
Revisión
Copyright
Copyright © European Psychiatric Association 1997

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Footnotes

DeClerk AC, Bisserbe JC. Short-term safety profile of zolpidem: objective measures of cognitive effects. Eur Psychiatry 1997; 12 (Suppl 1): 15S-20S.

References

Bibliografia

Balkin, TJ, O’Donnel, VM, Wesensten, N, McCann, U, Belenky, G.Comparison of the daytime sleep and performance effects of zolpidem versus triazolam. Psychopharmacology 1992; 107; 83-8.CrossRefGoogle 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 1990; 30: 463-9.CrossRefGoogle 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 Psychopharmacol 1993; 13 (2): 100-6.CrossRefGoogle Scholar
Besset, A, Tafti, M, Billiard, M. Effects of zolpidem on sleep architecture and daytime psychomotor skills in poor sleepers. In; Abstract books. 10 th Congress of the European Sleep Research Society, Strasbourg. 2025 May 1990; 138.Google Scholar
Borbely, AA, Youmbi-Balderer, G, Jaggi-Schwarz, K.Zolpidem (10 mg and 20 mg): hypnotic action and residual effects after a single bedtime dose. In: Sauvanet, JP, Lager, SZ, Morselli, PL, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988: 205-10.Google 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. In: Book of abstracts, WFSRS, Cannes, France, 21-25 Sept. 1991. Sleep Res 1991; 20A: 124.Google 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. In: Book of abstracts, WFSRS, Cannes, France, 21-25 Sept. 1991. Sleep Res 1992; 20A: 126.Google 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 1992; 43: 597-601.CrossRefGoogle ScholarPubMed
Hoffman, G, Lebon, O, Lebuck, R.Effects of zolpidem on polysomnography and daytime performance in psychophysiological insomnia. In: Book of abstracts, WFSRS, Cannes, France, 21-25 Sept. 1991. Sleep Res 1991; 20A: 330.Google 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 1992; 7; 325-30.CrossRefGoogle Scholar
Jackson, JL, Louwerens, JW, Cnossen, F, de Jong, HTP.Testing the effects of hypnotics on memory via the telephone: fact or fiction. Psychopharmacology 1993; 111: 127-33.CrossRefGoogle ScholarPubMed
Kryger, MH, Steljes, D, Pouliot Z, Neufeld H, Odynsky, T. Subjetive versus objetive evaluation of hypnotic efficacy: experience with zolpidem. Sleep 1991; 14: 339-407.CrossRefGoogle Scholar
Kurtz, D, Baas, V, Rumbach, L.Effects de l’administration répétée de zolpidem 10 mg sur le sommeil et la vigilance diurne chez des mauvais dormeurs. In: Symposium STILNOX lst Imidazopyridine. 10th Congress of the European Sleep Research Society, Strasbourg, 20-25 May 1990. Aukland: ADIS 1991: 143-51.Google Scholar
Lorizio, A, Terzano, M, Panino, L.Controlled study of the efficacy and safety of two oral doses of zolpidem (10 and 20 mg). In: Sauvanet, JP, Lager, SZ, Morselli, P, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988: 384.Google Scholar
Lund, R, Ruther, E, Wober, , Hippius, H.Effects 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, PL, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York. Raven Press, 1988: 193-203.Google Scholar
Merlotti, L, Roehrs, T, Koshorek, G, Zorick, F, Lamphere, J, Roth, T. The dose effects of zolpidem on the sleep of healthy normais. J Clin Psychopharmacol 1989; 9: 9-14.CrossRefGoogle Scholar
Monti, JM. Effect of zolpidem on sleep in insomniac patients. Eur J Clin Pharmacol 1989; 36: 461-6.CrossRefGoogle ScholarPubMed
Morselli, PL, Larribaud, J, Guillet, P et al. Daytime residual effects of zolpidem: a review of a avaible data. In: Sauvanet, JP, Lager, SZ, Morselli, PL, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988: 183-191.Google Scholar
Nicholson, A, Pascoe, P. Hypnotic activity of an imidazopyridine (zolpidem). Br J Pharmacol 1986; 21: 205-11.CrossRefGoogle Scholar
Poirrier, R, Lacroix, A, Scheldewaert, R, Jolie, A, Franck, G. Effects à long terme de Timidazopyridine hypnosélective zolpidem sur la polysomnographie noctume et le test itératif d’endornissement en cas d’insomnie psycho-physiologique. Annual Meeting of the Belgian Association for the study of sleep, Brussels, 1990.Google Scholar
Richens, A, Mercer, AJ, Jones, DM, Griffiths, A, Marshall, RW. Effects of zolpidem on saccadie eye movements and psychomotor performance: a double-blind, placebo controlled study in healthy volunteers. Br J Clin Pharmacol 1993; 36: 61-5.CrossRefGoogle ScholarPubMed
Scharf, MB, Mendels, J, Weiss, B, Therapy, M.Safety and efficacy of long-term zolpidem treatment in insomniac. Sleep Res 1990; 19: 87.Google Scholar
Scharf, MB, Mayleben, DW, Kaffeman, M, Krall, R, Ochs, R. Dose-response effects of zolpidem in normal geriatric subjects. J Clin Psychiatry 1991; 52: 77-83.Google ScholarPubMed
Scharf, M, Schweitzer, P, Fleming, J et al. Comparison of residual effects and efficacy of zolpidem, flurazepam and placebo in patients with chronic insomnia. In: Abstracts of the 18th Collegium Internationale Neuro- Psycopharmacologicum Congress, Nice, France, 28 June-2 July 1992.Google Scholar
Sicard, B, Trocherie, S, Moreau, J et al. Assessment of zolpidem's residual effects on alertness and psychomotor abilities in navy pilots and air force personnels. In: Abstracts of the 11 th European Congress on Sleep Research, Helsinki, Finland 5-10 July 1992. J Sleep Res 1992; 1 (suppl 1): 212.Google 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. In: Abstracts of the 11 th European Congress of the ESRS, Finland 5-10 July 1992. J Sleep Res 1992; 1 (suppl 1): 228.Google Scholar
Vaucher, M, Osiek, C, Shulz, P.Influence of zolpidem, flunitrazepam and placebo on the cognitive and memory functions in healthy subjects. Therapie 1988; 43: 163.Google Scholar
Vermeeren, A, O’Hanlon, JF, Declerck, AC, Kho, L, Janssen, FH.Comparaison des effects résiduels du zolpidem, du flunitrazépam et de la privation de sommeil sur la memoire, l’apprentissage et la conduite automobile. In: Symposium STILNOX lst Imidazopyridine. lOth Congress of the European Sleep Research Society, Strasbourg, 20-25 May 1990. Aukland: ADIS 1990: 130-2.Google Scholar
Vogel, G, Thurmond, A, Macintosch, M, Clifton, T.The effects of zolpidem on transient insomnia. Sleep Res 1988; 17: 67.Google Scholar
Walsh, JK, Schweitzer, PK, Sugerman, JL, Muehlbach, MJ. Transient insomnia associated with a 3-hour phase advance of sleep timne and treatment with zolpidem. J Clin Psychopharmacol 1990; 10: 184-9.CrossRefGoogle 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. In: Abstracts of the Association of Professional Sleep Societies Meeting, Toronto, Canada, 14-19 June 1991. Sleep Res 1991; 20: 92.Google Scholar