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

Sleep Medicine

Volumn 7, Issue 5, 2006, Pages 397-406

  Roth, Thomas ^a   Soubrane, Christina ^a,b   Titeux, Laurence ^b   Walsh, James K ^c   on behalf of the Zoladult Study Group, ^d  

^a Henri Ford Hospital   (United States)

^b SANOFI   (France)

^c ST LUKE S HOSPITAL   (United States)

^d NONE

Author keywords

Hypnotic medication; Modified release zolpidem; Polysomnographic sleep parameters; Primary insomnia; Single blind placebo; Sleep maintenance

Indexed keywords

PLACEBO; ZOLPIDEM; ZOLPIDEM TARTRATE;

ADULT; ARTICLE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EYE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; INSOMNIA; LATENT PERIOD; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; OUTCOMES RESEARCH; POLYSOMNOGRAPHY; PRIORITY JOURNAL; PSYCHOMETRY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REBOUND; SLEEP INDUCTION; SLEEP PARAMETERS; SLEEP WAKING CYCLE; SOMNOLENCE;

ADOLESCENT; ADULT; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MIDDLE AGED; POLYSOMNOGRAPHY; PSYCHOMOTOR PERFORMANCE; PYRIDINES; QUESTIONNAIRES; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 33746289069     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2006.04.008     Document Type: Article

References (27)

1. Moul D.E., Nofzinger E.A., Pilkonis P.A., et al. Symptom reports in severe chronic insomnia. Sleep 25 5 (2002) 553-563
2. Roth T. Measuring treatment efficacy in insomnia. J Clin Psychiatry 65 Suppl. 8 (2004) 8-12
3. Berman T.M., Nini-Murcia G., and Roehrs T. Sleep disorders: take them seriously. Patient Care 24 (1990) 85-112
4. Drake C.L., Roehrs T.A., and Burduvali E. Effects of rapid versus slow accumulation of eight hours of sleep loss. Psychophysiology 38 (2001) 979-987
5. Rosenthal L., Roehrs T.A., and Rosen A. Level of sleepiness and total sleep time following various time in bed conditions. Sleep 16 (1993) 226-232
6. Pilcher J.J., and Huffcutt A.I. Effects of sleep deprivation on performance: a meta-analysis. Sleep 19 4 (1996) 318-326
7. Seidel W.F., Ball S., Cohen S., et al. Daytime alertness in relation to mood, performance, and nocturnal sleep in chronic insomniacs and noncomplaining sleepers. Sleep 7 (1984) 230-238
8. Lichstein K.L., Wilson N.M., Noe S.L., et al. Daytime sleepiness in insomnia: behavioral, biological, and subjective indices. Sleep 17 (1994) 693-702
9. Krystal A.D. The changing perspective on chronic insomnia management. J Clin Psychiatry 65 Suppl. 8 (2004) 20-25
10. Roth T., Hajak G., and Ustun T.B. Consensus for the pharmacological management of insomnia in the new millennium. Int J Clin Pract 55 1 (2001) 42-52
11. Roth T. New developments for treating sleep disorders. J Clin Psychiatry 62 Suppl. 10 (2001) 3-4 (see also pages 18-26)
12. Langer S., Mendelson W., and Richardson G. Symptomatic treatment of insomnia. Sleep 22 Suppl. 3 (1999) S437-S450
13. Dooley M., and Plosker G.L. Zaleplon: a review of its use in the treatment of insomnia. Drugs 60 2 (2000) 413-445
14. Holm K.J., and Goa K.L. Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs 59 4 (2000) 865-889
15. Erman M.K., Erwin C.W., Gengo F.M., et al. Comparative efficacy of zolpidem and temazepam in transient insomnia. Human Psychopharmacol 16 (2001) 169-176
16. Walsh J.K., Roth T., Randazzo A., et al. Eight weeks of non-nightly use of zolpidem for primary insomnia. Sleep 23 8 (2000) 1087-1096
17. Scharf M.B., Roth T., Vogel G.W., and Walsh J.K. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry 55 (1994) 192-199
18. Roth T., Roehrs T., and Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind, randomized comparison with placebo. Sleep 18 4 (1995) 246-251
19. Kryger M.H., Steljes D., Pouliot Z., et al. Subjective versus objective evaluation of hypnotic efficacy: experience with zolpidem. Sleep 14 5 (1991) 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 J.C., Walsh J.K., Scharf M.B., et al. Minimal rebound insomnia after treatment with 10-mg zolpidem. Clinic Neuropharmacol 20 2 (1997) 116-125
24. Lahmeyer H., Wilcox C.S., Kann J., and Leppik I. Subjective efficacy of zolpidem in outpatients with chronic insomnia. Clin Drug Invest 13 3 (1997) 134-144
25. Voshaar R.C.O., Van Balkom A.J.L.M., and Zitman F.G. Zolpidem is not superior to temazepam with respect to rebound insomnia: a controlled study. Eur Neuropharmacol 14 (2004) 301
26. Soldatos C.R., Dikeos D.G., and Whitehead A. Tolerance and rebound insomnia with rapidly eliminated hypnotics: a meta-analysis of sleep laboratory studies. Int Clin Psychopharmacol 14 5 (1999) 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 26 7 (2003) 793-799