2012, Number 5
<< Back Next >>
Rev Med Inst Mex Seguro Soc 2012; 50 (5)
Efficacy and safety of modified release zolpidem in patients with chronic insomnia
Jiménez-Genchi A
Language: Spanish
References: 32
Page: 529-536
PDF size: 151.63 Kb.
ABSTRACT
Objective: to assess the efficacy and safety of zolpidem modified
release (MR) on an “as per needed basis” in patients with
chronic insomnia.
Methods: one hundred and thirty five adult patients with chronic
insomnia were recruited. Participants received zolpidem MR
12.5 mg during a 12 weeks period. Severity and improvement
of insomnia were assessed at baseline and at the end of study
using the clinical global impression scale; sleep quality was
assessed by the application of the Pittsburgh Sleep Quality
Index; drug consumption behavior was evaluated through tablet
counting; in addition its security was assessed by the registry
of the adverse effects.
Results: one hundred and fifteen patients completed the study;
83.7 % were considered improved or very improved, so that
66 % reached a normal or borderline condition. Twenty percent
of subjects experienced adverse reactions; the most frequent
were headache, excessive sleepiness, nausea and dizziness.
Conclusions: these data support the efficacy, safety and acceptance
of zolpidem MR administered on an “as per needed”
regimen for the treatment of chronic insomnia.
REFERENCES
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth edition. Washington DC: APA; 1994.
American Academy of Sleep Medicine. International Classification of Sleep Disorders. Second edition. Chicago, IL: American Academy of Sleep Medicine; 2005.
Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev 2002;6(2):97-111.
Téllez-López A, Guerrero-Sánchez ME, Gutiérrez-Torres F, Niño-Ramírez MP, Silva-Olivares MV. Hábitos y trastornos del dormir en residentes del área metropolitana de Monterrey. Salud Mental 1995;18(1):14-22.
Bouscoulet LT, Vázquez-García JC, Muiño A, Márquez M, López MV, Montes de Oca M, PLATINO Group. Prevalence of sleep related symptoms in four Latin American cities. J Clin Sleep Med 2008;4(6):579-585.
Swainston-Harrison T, Keating GM. Zolpidem: a review of its use in the management of insomnia. CNS Drugs 2005;19(1):65-89.
Moen MD, Plosker GL. Zolpidem extended-release. CNS Drugs 2006;20(5):419-426.
Weinling E, McDougall S, Andre F, Bianchetti G, Dubruc C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol 2006;20(4):397-403.
Greenblatt DJ, Legangneux E, Harmatz JS, Weinling E, Freeman J, Rice K, et al. Dynamics and kinetics of a modified-release formulation of zolpidem: comparison with immediate-release standard zolpidem and placebo. J Clin Pharmacol 2006;46(12):1469-1480.
Roth T, Soubrane C, Titeux L, Walsh JK; Zoladult Study Group. Efficacy and safety of zolpidem-MR: a double-blind, placebo-controlled study in adults with primary insomnia. Sleep Med 2006;7(5):397-406.
Walsh JK, Soubrane C, Roth T. Efficacy and safety of zolpidem extended release in elderly primary insomnia patients. Am J Geriatr Psychiatry 2008;16(1):44-57.
Krystal AD, Erman M, Zammit GK, Soubrane C, Roth T; SOLONG Study Group. Long term efficacy and safety of zolpidem extended –release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6 month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep 2008;31(1):79-90. Disponible en http://www.ncbi.nlm.nih. gov/pmc/articles/PMC2225552/
Ancoli-Israel S, Roth T. Characteristics of insomnia in the United States: results of the 1991 National Sleep Foundation Survey I. Sleep 1999;22(Suppl 2):S347-S353.
Janson C, Lindberg E, Gislason T, Elmasry A, Boman G. Insomnia in men: a 10-year prospective population based study. Sleep 2001;24(4):425-430.
Hohagen F, Kappler C, Schramm E, Riemann D, Weyerer S, Berger M. Sleep onset insomnia, sleep maintaining insomnia and insomnia with early morning awakening – temporal stability of subtypes in a longitudinal study on general practice attenders. Sleep 1994;17(6):551-554.
Vallieres A, Ivers H, Bastien CH, Beaulieu-Bonneau S, Morin CM. Variability and predictability in sleep patterns of chronic insomniacs. J Sleep Res 2005;14(4):447-453.
Cluydts R. Zolpidem “as needed”: Methodological issues and clinical findings. CNS Drugs 2004;18(Suppl 1):25-33.
Hajak G. Zolpidem “as needed” versus continuous administration: Pan-European study results. Sleep Med Rev 2002;6 (Suppl 1):S21-S28.
Lévy P, Massuel MA, Gérard DA. “As-needed” prescription of zolpidem for insomnia in routine general practice. Clin Drug Invest 2004;24(11):625-632.
Walsh JK. Zolpidem “as needed” for the treatment of primary insomnia: A double-blind, placebo controlled study. Sleep Med Rev 2002;6 (Suppl 1):S7-S11.
Guy W, editor. ECDEU Assessment Manual for Psychopharmacology, revised. Rockvillle, MD, U.S.: National Institute of Mental Health; 1976. Clinical global impression (CGI).
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Res 1989; 28(2):193-213.
Jiménez GA, Monteverde ME, Nenclares PA, Esquivel AG, de la Vega PA. Confiabilidad y análisis factorial del índice de calidad de sueño de Pittsburgh en pacientes psiquiátricos. Gac Med Mex 2008;144(6):491-496.
Lichstein KL, Durrence HH, Taylor DJ, Bush AJ, Riedel BW. Quantitative criteria for insomnia. Behav Res Ther 2003;41 (4):427-445.
World Health Organization. The ICD-10 classification of mental and behavioral disorders: Clinical descriptions and diagnostic guidelines. Geneva: WHO; 1992.
Morgenthaler TI, Silber MH. Amnestic sleep-related eating disorder associated with zolpidem. Sleep Med 2002;3(4): 1075-1084.
Schenck C, Connoy D, Castellanos M. Zolpidem-induced sleep related eating disorder (SRED) in 19 patients. Sleep 2005;28(Suppl):A259.
Dolder CR, Nelson MH. Hypnosedative-induced complex behaviours: incidence, mechanisms and management. CNS Drugs 2008;22(12):1021-1036.
Ben-Hamou M, Marshall NS, Grunstein RR, Saini B, Fois RA. Spontaneous adverse event reports associated with zolpidem in Australia 2001-2008. J Sleep Res 2011;20(4): 559-568.
Ganzoni E, Santoni JP, Chevillard V, Sébille M, Mathy B. Zolpidem in insomnia: a 3-year post-marketing surveillance study in Switzerland. J Int Med Res 1995;23(1):61-73.
Sauvanet J, Maarek L, Roger M, Renaudin J, Louvel E, Orofiamma B. Open long-term trials with zolpidem in insomnia. En: Sauvanet J, Langer S, Morselli P, editores. Imidazopyridines in sleep disorders. New York: Raven Press; 1988. p. 339-349.
Hwang TJ, Ni HC, Chen HC, Lin YT, Liao SC. Risk predictors for hypnosedative-related complex behaviors: a retrospective, cross-sectional pilot study. J Clin Psychiatry 2010;71 (10):1331-1335.