Sleep Medicine
Volume 7, Issue 5 , Pages 397-406 , August 2006

Efficacy and safety of zolpidem-MR: A double-blind, placebo-controlled study in adults with primary insomnia

  • Thomas Roth

      Affiliations

    • Henri Ford Hospital, 2799 West Grand Boulevard Detroit, MI 48202, USA
    • ,
  • Christina Soubrane

      Affiliations

    • Henri Ford Hospital, 2799 West Grand Boulevard Detroit, MI 48202, USA
    • Clinical Development, sanofi-aventis Research Chilly Mazarin, France
    • Drs Soubrane and Titeux are employed by sanofi-aventis.
    • Corresponding Author InformationCorresponding author. Address: Henry Ford Sleep Disorders Center, 2799 West Grand Boulevard CFP-3, Detroit, MI 48202, USA. Tel.: +1 69 79 42 36; fax: +1 69 79 48 05.
    • ,
  • Laurence Titeux

      Affiliations

    • Clinical Biostatistics, sanofi-aventis Research Chilly Mazarin, France
    • Drs Soubrane and Titeux are employed by sanofi-aventis.
    • ,
  • James K. Walsh

      Affiliations

    • St Luke's Hospital 232 South Woods Mill Road, Chesterfield, MO 63017, USA
    • ,
  • on behalf of the Zoladult Study Group

Received 10 November 2005 ,Revised 11 April 2006 ,Accepted 13 April 2006.

References 

  1. Moul DE, Nofzinger EA, Pilkonis PA, et al. Symptom reports in severe chronic insomnia. Sleep. 2002;25(5):553–563
  2. Roth T. Measuring treatment efficacy in insomnia. J Clin Psychiatry. 2004;65(Suppl. 8):8–12
  3. Berman TM, Nini-Murcia G, Roehrs T. Sleep disorders: take them seriously. Patient Care. 1990;24:85–112
  4. Drake CL, Roehrs TA, Burduvali E. Effects of rapid versus slow accumulation of eight hours of sleep loss. Psychophysiology. 2001;38:979–987
  5. Rosenthal L, Roehrs TA, Rosen A. Level of sleepiness and total sleep time following various time in bed conditions. Sleep. 1993;16:226–232
  6. Pilcher JJ, Huffcutt AI. Effects of sleep deprivation on performance: a meta-analysis. Sleep. 1996;19(4):318–326
  7. Seidel WF, Ball S, Cohen S, et al. Daytime alertness in relation to mood, performance, and nocturnal sleep in chronic insomniacs and noncomplaining sleepers. Sleep. 1984;7:230–238
  8. Lichstein KL, Wilson NM, Noe SL, et al. Daytime sleepiness in insomnia: behavioral, biological, and subjective indices. Sleep. 1994;17:693–702
  9. Krystal AD. The changing perspective on chronic insomnia management. J Clin Psychiatry. 2004;65(Suppl. 8):20–25
  10. Roth T, Hajak G, Ustun TB. Consensus for the pharmacological management of insomnia in the new millennium. Int J Clin Pract. 2001;55(1):42–52
  11. Roth T. New developments for treating sleep disorders. J Clin Psychiatry. 2001;62(Suppl. 10):3–4(see also pages 18–26)
  12. Langer S, Mendelson W, Richardson G. Symptomatic treatment of insomnia. Sleep. 1999;22(Suppl. 3):S437–S450
  13. Dooley M, Plosker GL. Zaleplon: a review of its use in the treatment of insomnia. Drugs. 2000;60(2):413–445
  14. Holm KJ, Goa KL. Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs. 2000;59(4):865–889
  15. Erman MK, Erwin CW, Gengo FM, et al. Comparative efficacy of zolpidem and temazepam in transient insomnia. Human Psychopharmacol. 2001;16:169–176
  16. Walsh JK, Roth T, Randazzo A, et al. Eight weeks of non-nightly use of zolpidem for primary insomnia. Sleep. 2000;23(8):1087–1096
  17. Scharf MB, Roth T, Vogel GW, Walsh JK. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry. 1994;55:192–199
  18. Roth T, Roehrs T, Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind, randomized comparison with placebo. Sleep. 1995;18(4):246–251
  19. Kryger MH, Steljes D, Pouliot Z, et al. Subjective versus objective evaluation of hypnotic efficacy: experience with zolpidem. Sleep. 1991;14(5):399–407
  20. Hindmarch I, Legangneux E, Stanley N. A randomized double-blind placebo-controlled 10-way cross-over study shows that a new modified-release formulation improves sleep maintenance compared to standard zolpidem. Sleep 2004;(Suppl. A55).
  21. Weinling E, Andre F, Dubruc C, et al., Pharmacokinetic profile of a new modified-release formulation of zolpidem designed to improve sleep maintenance. Sleep 2004;(Suppl. A271).
  22. Rechtschaffen A, Kales A. A manual for standardized terminology, techniques and scoring system for sleep stages of human subjects. US Department of Health, Education, and Welfare, National Institutes of Health. Publication no. 204; 1968.
  23. Ware JC, Walsh JK, Scharf MB, et al. Minimal rebound insomnia after treatment with 10-mg zolpidem. Clinic Neuropharmacol. 1997;20(2):116–125
  24. Lahmeyer H, Wilcox CS, Kann J, Leppik I. Subjective efficacy of zolpidem in outpatients with chronic insomnia. Clin Drug Invest. 1997;13(3):134–144
  25. Voshaar RCO, Van Balkom AJLM, Zitman FG. Zolpidem is not superior to temazepam with respect to rebound insomnia: a controlled study. Eur Neuropharmacol. 2004;14:301
  26. Soldatos CR, Dikeos DG, Whitehead A. Tolerance and rebound insomnia with rapidly eliminated hypnotics: a meta-analysis of sleep laboratory studies. Int Clin Psychopharmacol. 1999;14(5):287–303
  27. Krystal A, Walsh J, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep. 2003;26(7):793–799

PII: S1389-9457(06)00114-6

doi: 10.1016/j.sleep.2006.04.008

Sleep Medicine
Volume 7, Issue 5 , Pages 397-406 , August 2006

Article Tools

* Image Usage & Resolution