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Perfil de seguridad general de zolpidem en ancianos, sobredosis y efectos de rebote

Published online by Cambridge University Press:  12 May 2020

H. Allain  and
J. Monti
H. Allain
Affiliation:
Laboratorio de Farmacología Clínica, Centro Hospitalario Regional y Universitario de Rennes, Francia
J. Monti
Affiliation:
Departamento de Farmacología y Terapéutica, Facultad de Medicina, Hospital de Clínicas, Montevideo, Uruguay
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Resumen

Se revisan los diferentes aspectos de la seguridad general de zolpidem después de analizar los datos de seguridad obtenidos en adultos y en pacientes ancianos. La baja incidencia de comunicaciones de acontecimientos adversos durante los tres primeros años de utilización de zolpidem ha corroborado los resultados de los estudios clínicos. Los efectos adversos más frecuentes están relacionados con el sistema nervioso central (SNC), pero se pueden prevenir en gran medida respetando las dosis recomendadas y las reglas de prescripción. En los casos de sobredosis aguda, no se han atribuido complicaciones graves a zolpidem en monoterapia. En la mayoría de los estudios realizados en el período de tratamiento recomendado, la interrupción brusca del mismo no se asociaba con insomnio de rebote clínicamente significativo. Los datos preclínicos y clínicos disponibles indican que el riesgo de abuso o dependencia es mínimo cuando se prescribe según las dosis recomendadas de 10 mg en adultos y 5 mg en ancianos. Así, con argumentos ahora bien establecidos que van en la misma dirección sobre una gran base de pacientes, el perfil de seguridad de zolpidem puede autorizar y justificar su prescripción amplia en el tratamiento a corto plazo del insomnio.

Keywords

zolpidemhipnóticotoleranciaseguridadintoxicaciónrebotedependencia
Type
Revisión
Information
European Psychiatry (Ed. Española) , Volume 3 , Issue 3 , June 1996 , pp. 155 - 165
Copyright
Copyright © European Psychiatric Association 1996

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References

Bibliografia

Agoumi, WGuerault, EChaumet-Riffaud, AMorselli, P. Effect of abrupt discontinuation of zolpidem: a retrospective evaluation of pooled phase II and III european clinical studies.In: Abstracts of the 11 th European Congress of the European Sleep Research Society, Helsinki, Finland, 5-10 July 1991. J Sleep Res 1992; 1 (suppl 1): 521.Google Scholar
Ahrens, J. Treating sleep disorders using zolpidem. Therapiexvoche 1993; 43, 38: 1942–44.Google Scholar
APA. A task force report of the American Psychiatric Association on Benzodiazepine dependence toxicity and abuse, Washington, DC: APA, 1990.Google Scholar
Armangaud, MHAubier, MPariente, Ret al. Effects du zolpidem, duflunitrazépam et du triazolam sur les centres respiratoires et les gaz du sang ártériel chez de patients porteurs d ‘une bronchopneumopathie chronique obstructive.In: Abstract books, lOth Congress of the European Sleep Research Society, Strasbourg, 20-25 May 1990. Adis 1990; 165-9.Google Scholar
Aubier, MCramer, PMurciano, DNeveux, E. Comparison of the effects of zolpidem, triazolam and flunitrazepam on the respiratory regulatory centre activity in patients with chronic obstructive pulmonary disease (COPD). Biol Psychiatry 1991; 29: 333S–701S.Google Scholar
Baca, E. Calidad de vida en el estudio de la electividad de los hipnóticos: experiencias con zolpidem. Sixth European Psychiatrists. Barcelona, 3-7 November 1992.Google Scholar
Benoît, OBouard, GPayan, CBorderies, PPrado, J. Effect of a single dose (10 mg) of zolpidem on visual and spectral analysis of sleep in young poor sleepers. Psychopharmacology 1994; 116: 297–303.CrossRefGoogle Scholar
Besset, ATafti, MBilliard, M. Effects of zolpidem on sleep architecture and daytime psychomotor skills in poor sleepers.In: Abstract books, l0th Congress of the European Sleep Research Society, Strasbourg, 20-25 May 1990. Adis 1990; 138.Google Scholar
Biondi, FCasedi, GL. Abrupt shift to zolpidem 10 mg in insomniac patients previously taking benzodiazepine (BZD) - like hypnotics.3rd International Congress APPAC Developments in Psychiatry and Neurology of the Adult and the Child. Athens, 2-5 December 1993.Google Scholar
Biondi, FCasadei, GL. Results of a multicentre trial with the hypnotic zolpidem in 1152 insomniac patients.Curr Ther Res 1994; 55 (3): 262–74.CrossRefGoogle Scholar
Borbely, AYoumbi-Balderer, GJaggi-Schwarz, K. Zolpidem (10 mg and 20 mg): hypnotic action and residual effects after a single bedtime dose.In: Sauvanet, JPLager, SZMorselli, 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
Calanca, ADick, P. Efficacité du nouvel hypnotique zolpidem (Stilnox) en practique ambulatoire (étude coopérative de paticiens de Genève, Lausanne et Tessin). Rev Méd Suisse Romande 1991; 111: 85–8.Google Scholar
Chaumet-Riffaud, ADesforge, CLavoisy, J. Review of the post-marketing surveillance experience collected with zolpidem during the First three years after launch in Europe.In: Abstracts of the 11 th European Congress of the ERSS, Finland 5-10 July 1992. J Sleep Res 1992; 1 (suppl 1): 40.Google Scholar
Ciapparelli, AColombo, CCuccato, GLevi-Minzi, ALorizio, A. Shift to zolpidem, a new imidazopyridine hypnotic, in insomniac patients previously taking benzodiazepine hypnotics. Minerva Psichiatr 1991; 32: 3–12.Google Scholar
Cluydts, RDeRoeck, JJolie, A. A three week multicentre general practitioner study of zolpidem in 651 patients with insomnia. Acta Ther 1993; 19 (1): 73–91.Google Scholar
Davenne, DMeney, IMougin, Fet al. Physical performance the next afternoon of either an experimental sleep interruption or a night with zolpidem In: Book of abstracts, WFSRS, Cannes, France, 21-25 Sept. 1991; 20A: 463.Google Scholar
Depoortere, HZivkovic, BLloyd, Ket al. Zolpidem, a novel non-benzodiazepine hypnotic. I. Neuropharmacological and behavioral effects. J Pharmacol Exp Therap 1986; 237 (2): 649–58.Google Scholar
DeWit, HGriffiths, R. Testing the abuse liability of anxiolytics and hypnotic drugs in humans. Drug Alcohol Depend 1991; 28: 83–111.CrossRefGoogle Scholar
Emeriau, JDescamps, ADechelotte, Pet al. Zolpidem and flunitrazepam: a multicenter trial in elderly hospitalised patients.In: Sauvanet, JPLager, SZMorselli, PL, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988; 317-26.Google Scholar
Evans, SMFunderburk, FRGriffiths, RR. Zolpidem and triazolan in humans: behavioural and subjective effects and abuse liability. J Pharmacol Exp Ther 1990; 255: 1246–55.Google Scholar
Fairweather, DKerre, JHindmarch, I. The effects of acute and repeated doses of zolpidem on subjetive sleep, psychomotor performance and cognitive function in elderly volunteers. Eur J Clin Pharmacol 1992; 43: 597–601.CrossRefGoogle Scholar
Garnier, RGuerault, EMuzard, D, et al. Acute zolpidem poisoning analysis of 344 cases. Clin Toxicol 1994; 32 (4): 391–404.Google ScholarPubMed
Ganzoni, ESantoni, JPChevillard, VSebille, MMathy, B. Zolpidem in insomnia: a 3-year PMS study in Switzerland.J Intern Med Res 1994; in press. (Preliminary results presented Assoc Eur Psychiatrists, Copenhagen, Denmark, 1994).Google Scholar
Godderis, JCluydts, R. Substitution from a benzodiazepine to zolpidem in elderly insomniacs: preliminaiy data.In: Abstracts of the 11 th European Congress of the ESRS, Helsinki, Finland, 5-10 July 1992. Sleep Res 1992; 1 (suppl 1): 83.Google Scholar
Griffiths, RSannerud, CAtor, NBrady, J. Zolpidem behavioral pharmacology in baboons: self-injection, discrimination, tolerance and withdrawl. J Pharmacol Exp Ther 1992; 260 (3): 1199–208.Google Scholar
Guerault, EChaumet-Riffaud, AMorselli, Pet al. Neurological adverse event profile in the elderly with zolpidem 5 mg and 10 mg: a retrospective evaluation of European phase II and III studies.In: Abstracts of the 11 th European Congress of the ESRS, Finland 5-10 July 1992. J Sleep Res 1992; 1 (supp 1): 89.Google Scholar
Jonville, APAutret, EDutertre, JPet al. Intoxications par les psychotropes et les toxiques. Rev Med Tours 1991; 25: 61–3.Google Scholar
Kummer, JGuendel, LKyrein, Het al. Sleep-EEG profile of elderly insomniacs during long-term treatment with zolpidem.In: Sauvanet, JPLager, SZMorselli, PL, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988; 381.Google Scholar
Kurtz, DBaas, VRumbach, L. Effets de l’administration repetee de zolpidem 10 mg sur le sommeil et la vigilance diume chez des mauvais dormeurs.In: Abstract book of the Symposium Stilnox Ist Imidazopyridine. lOth Congress of the European Sleep Research Society, Strasbourg, 20-25 May 1990. Adis, 1991; 143-51.Google Scholar
Lader, M. Rebound insomnia and newer hypnotics. Psychopharmacology 1992; 108: 248–55.CrossRefGoogle ScholarPubMed
Lahmeyer, HDocherty, JFillingim, Jet al. The effects of zolpidem in outpatients with chronic insomnia. Sleep Res 1990; 19: 70.Google Scholar
Langer, SArbilla, S. Limitations of the benzodiazepine receptor nomenclature: a proposal for a pharmacological classification as omega receptor subtypes. Fundam Clin Pharmacol 1988; 2 (3): 159–70.CrossRefGoogle ScholarPubMed
Lheureux, PDebailleul, GDeWitte, OAskenasi, R. Zolpidem intoxication mimicking narcotic overdose: response to flumazenil. Hum Exp Toxicol 1990; 9: 105–7.CrossRefGoogle ScholarPubMed
Licciardello, LLicini, P. Safety and efficacy of zolpidem therapy in sleep disorders: a multicenter trial in hospitalized patients. Curr Ther Res Clin Exp 1992; 52: 652–8.CrossRefGoogle Scholar
Lorizio, ATerzano, MParrino, L. Controlled study of the efficacy and safety of two oral doses of zolpidem (10 and 20 mg).In: Sauvanet, JPLager, SZMorselli, PL eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988; 385.Google Scholar
Maarek, LCramer, PAttali, Pet al. The safety and efficacy of zolpidem in insomniac patients: a long-term open study in general practice. J Int Med Res 1992; 20: 162–70.CrossRefGoogle ScholarPubMed
Maggioni, MFrattola, L. Double-blind controlled study of the efficacy and safety of zolpidem versus flunitrazepam.In: Sauvanet, JPLager, SZMorselli, PL, eds. Imidazopyridines in sleep disorders: a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988; 386–7.Google Scholar
Maillard, DThiercelin, JFFuseau, Eet al. Effects of zolpidem versus diazepam and placebo on breathing control parameters in healthy human subjects and heavy snoorers. Int J Clin Pharm Res 1992; 12: 27–35.Google Scholar
Merlotti, LRoehrs, TKoshorek, Get al. The dose effects of zolpidem on the sleep of healthy normais. J Clin Psychomarcol 1989; 9: 9–14.Google Scholar
Monti, J. Effect of zolpidem on sleep in insomniac patients. Eur J Clin Pharmacol 1989; 36: 461–6.CrossRefGoogle ScholarPubMed
Monti, JMAttali, PMonti, DZipfel, ADe la Giclais, BMorselli, PL. Zolpidem and rebound insomnia. A double-blind, controlled polysomnographic study in chronic insomniac patients. Pharmacopsyhiatria 1994; 27: 166–75.CrossRefGoogle ScholarPubMed
Murciano, DMoreau, JBarthouil, PAuber, M. Long term effects of zolpidem (Z) on arterial blood gases and control of breathing in patients with severe chronic obstructive pulmonary disease (COPD).In: Abstracts of the International Conference of the American Lung Association and the American Thoracic Society, Miami Beach, Florida, USA 17-20 May 1992. Am Rev Respir Dis 1992; 145: A636.Google Scholar
Ochs, RFillingis, JCutler, Met al. The effect of zolpidem in elderly patients with chronic insomnia.In: Abstracts of the 11 th European Congress of the European Sleep Research Society, Helsinki, Finland, 5-10 July 1992. J Sleep Res 1992; 1 (suppl 1): 164.Google Scholar
Pagot, RCramer, PL’Heritier, Cet al. Comparison of the efficacy and tolerability of zolpidem 20 mg and triazolam 0.5 mg in anxious or depressed insomniac patients. Curr Ther Res 1993; 53: 88–97.CrossRefGoogle Scholar
Paty, JBarthouil, P. Efficacy and tolerance of a shift from benzodiazepine hypnotic drugs to zolpidem 10 mg/day in chronic insomniacs: an open study based on general practitioners.In: Abstracts of the WESRS, Cannes, France, 21-25 September 1991.Google Scholar
Pelissolo, ABisserbe, JC, Benzodiazepine dependence: clinical aspects and biological perspectives. Encéphale 1994; 20: 147–57.Google Scholar
Perrault, GMorel, ESanger, DZivkovic, B. Differences in pharmacological profiles of a new generation of benzodiazepine and non-benzodiazepine hypnotics. Eur J Pharmacol 1990; 187 (3): 487–494.CrossRefGoogle ScholarPubMed
Perrault, GMorel, ESanger, DZivkovic, B. Lack of tolerance and pysical dependence upon repeated treatment with the novel hypnotic zolpidem. J Pharmacol Exp Therap 1992; 263 (1): 298–303.Google Scholar
Quera-Salva, TBorderies, PMoreau, JCugy, D. The efficacy of zolpidem during and after Progressive shift from benzodiazepine hypnotics in elderly chronic insomniac patients. J Sleep Res 1992; 1 (suppl 1): 187.Google Scholar
Rhodes, SParry, PHanning, C. A comparison of the effects of zolpidem and placebo on respiration and oxygen saturation during sleep in healthy elderly. Br J Clin Pharmacol 1990; 30: 817–24.CrossRefGoogle ScholarPubMed
Richens, AMercer, AJJones, DMGriffiths, AMarshal, RW. Effects of zolpidem on saccadic eye movements and psychomotor performance: a double-blind, placebo controlled study in healthy volunteers. Br J Clin Pharmacol 1993; 36: 61–5.CrossRefGoogle ScholarPubMed
Roehrs, TARoth, TScharf, Met al. Rebound insomnia potential of zolpidem 10 mg as evaluated Sleep Societies Annual Meeting, 1992; 134.Google Scholar
Roger, MAttali, PNicaise, Jet al. Efficacy of 5 mg and 10 mg zolpidem in the elderly: a double-blind study versus 0.25 mg triazolam.In: Abstraeis of the 5 th World Congress of Biological Psychiatry, Florence, Italy, 10-14 June 1991. Br J Psychiatry 1991; 19 (suppl 11): 52IS.Google Scholar
Roger, MAttali, PCoquelin, J. Multicenter, double-blind controlled comparison of zolpidem and triazolam in elderly patients with insomnia. Clin Ther 1993; 15: 127–35.Google ScholarPubMed
Sanger, DZivkovic, B. Differential development of tolerance to the depressant effects of benzodiazepine and non-benzodiacepine agonists at the omega modulatory sites of GABA A receptors. Neuropharmacology 1992; 31 (7): 693–700.CrossRefGoogle Scholar
Sauvanet, JPMaarek, LRoger, Met al. Open long-term triais with zolpidem in insomnia.In: Sauvanet, JPLager, SZMorselli, PL, eds. Imidazopyridines in sleep disorders: a novel approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988; 339-49.Google Scholar
Scharf, MBMayleben, DWKaffeman, Met al. Dose response effects of zolpidem in normal geriatric subjects. J Clin Psychiatry 1991a; 52: 77–83.Google Scholar
Scharf, MBVogel, GKaffeman, MOchs, RF. Dose-response of zolpidem in elderly patients with chronic insomnia. Sleep Res 1991b; 20: 84.Google Scholar
Schlich, DL’Hertier, CCoquelin, JAttali, P. Long-term treatment of insomnia with zolpidem: a multicentre general practitioner study of 107 patients. J Int Med Res 1991; 19: 271–9.CrossRefGoogle ScholarPubMed
Shaw, SCurson, HCoquelin, J. A double-blind, comparative study of zolpidem and placebo in the treatment of insomnia in elderly psychiatric in-patients. J Int Med Res 1992; 20: 150–61.CrossRefGoogle ScholarPubMed
Steens, RDPouliot, ZMillar, TWKryger, MHGeorge, CF. Effects of zolpidem and triazolam on sleep and respiration in mild to moderate chronic obstructive pulmonary disease. Sleep 1993; 16: 318–26.CrossRefGoogle ScholarPubMed
Tracqui, AKintz, PMangin, P. A fatality involving two unusual compounds -zolpid em and acepromazine. Am J Forensic Med Pathol 1993; 14: 309–12.CrossRefGoogle Scholar
Wheatley, D. Zolpidem and placebo: a study in general practice in patients suffering from insomnia.In: Sauvanet, JPLager, SZMorselli, PL, eds. Imidazopyridines in sleep disorders:a novel experimental and therapeutic approach. (LERS Monograph series; vol. 6). New York: Raven Press, 1988; 305-16.Google Scholar
World Psychiatric Association. Task Force on sedative hypnotics. Eur Psychiatry 1993; 8: 45–9.CrossRefGoogle Scholar