A new sublingual formulation of zolpidem for the treatment of sleep-onset insomnia

被引:1
作者
Staner, Luc [1 ,2 ]
Danjou, Philippe [3 ]
Luthringer, Remy [3 ]
机构
[1] Ctr Hosp Rouffach, Unite Explorat Rythmes Veille Sommeil, Rouffach, France
[2] Forenap R&D, F-68250 Rouffach, France
[3] Forenap Pharma, F-68250 Rouffach, France
关键词
Edluar (TM); insomnia; sleep induction; sleep-onset latency; sublingual formulation; zolpidem; NON-NIGHTLY USE; DOUBLE-BLIND; LONG-TERM; REBOUND INSOMNIA; POSTMARKETING SURVEILLANCE; DAYTIME ALERTNESS; GABA(A) RECEPTORS; BEHAVIOR-THERAPY; SQUIRREL-MONKEYS; ELDERLY-PATIENTS;
D O I
10.1586/ERN.11.197
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Insomnia is a very frequent complaint that periodically or permanently affects up to 60% of the general population. Valuable therapeutic options rely on pharmacological and nonpharmacological management of insomnia complaints. Zolpidem is one of the most popular hypnotic drugs used to treat insomnia. The drug was synthesized by Synthelabo Recherche in the early 19805 and has proved to be a suitable and well-tolerated drug, especially with regard to efficacy in sleep initiation. The present review focuses on an alternate delivery form of zolpidem, Edluar (TM), a new sublingual formulation of zolpidem that has been developed for the treatment of sleep-onset insomnia. Studies have shown that Edluar has a faster sleep-induction effect, whereas it did not differ from the oral formulation in terms of sleep maintenance or side effects. This review also discusses the mechanism of action of zolpidem and its pharmacokinetic profile in comparison to Edluar. Efficacy studies in specific settings (such as non-nightly use or use in combination with cognitive behavioral therapy) and particular safety issues encountered with zolpidem use are also discussed.
引用
收藏
页码:141 / 153
页数:13
相关论文
共 125 条
[1]  
AHRENS J, 1993, THERAPIEWOCHE SCHWEI, V9, P660
[2]   Efficacy and safety of zolpidem administered -: 'As needed' in primary insomnia results of a double-blind, placebo-controlled study [J].
Allain, H ;
Arbus, L ;
Schück, S .
CLINICAL DRUG INVESTIGATION, 2001, 21 (06) :391-400
[3]  
Ancoli-Israel Sonia, 1999, Prim Care Companion J Clin Psychiatry, V1, P114
[4]   Deletion of the α1 or β2 subunit of GABAA receptors reduces actions of alcohol and other drugs [J].
Blednov, YA ;
Jung, S ;
Alva, H ;
Wallace, D ;
Rosahl, T ;
Whiting, PJ ;
Harris, RA .
JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS, 2003, 304 (01) :30-36
[5]  
Bonnet M H, 1997, Sleep Med Rev, V1, P97, DOI 10.1016/S1087-0792(97)90012-5
[6]   PHARMACOKINETICS OF 2 LORAZEPAM FORMULATIONS, ORAL AND SUBLINGUAL, AFTER MULTIPLE DOSES [J].
CAILLE, G ;
SPENARD, J ;
LACASSE, Y ;
BRENNAN, J .
BIOPHARMACEUTICS & DRUG DISPOSITION, 1983, 4 (01) :31-42
[7]   Comparison of continuous versus intermittent administration of zolpidem in chronic insomniacs: a double-blind, randomized pilot study [J].
Cluydts, R ;
Peeters, K ;
de Bouyalsky, I ;
Lavoisy, J .
JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 1998, 26 (01) :13-24
[8]  
Coleman DE, 2004, J FORENSIC SCI, V49, P392
[9]   Loss of zolpidem efficacy in the hippocampus of mice with the GABAA receptor γ2 F77I point mutation [J].
Cope, DW ;
Halbsguth, C ;
Karayannis, T ;
Wulff, P ;
Ferraguti, F ;
Hoeger, H ;
Leppä, E ;
Linden, AM ;
Oberto, A ;
Ogris, W ;
Korpi, ER ;
Sieghart, W ;
Somogyi, P ;
Wisden, W ;
Capogna, M .
EUROPEAN JOURNAL OF NEUROSCIENCE, 2005, 21 (11) :3002-3016
[10]   Abolition of zolpidem sensitivity in mice with a point mutation in the GABAA receptor γ2 subunit [J].
Cope, DW ;
Wulff, P ;
Oberto, A ;
Aller, MI ;
Capogna, M ;
Ferraguti, F ;
Halbsguth, C ;
Hoeger, H ;
Jolin, HE ;
Jones, A ;
Mckenzie, ANJ ;
Ogris, W ;
Poeltl, A ;
Sinkkonen, ST ;
Vekovischeva, OY ;
Korpi, ER ;
Sieghart, W ;
Sigel, E ;
Somogyi, P ;
Wisden, W .
NEUROPHARMACOLOGY, 2004, 47 (01) :17-34