A 2-week efficacy and safety study of gaboxadol and zolpidem using electronic diaries in primary insomnia outpatients

Sleep Medicine

Volumn 10, Issue 7, 2009, Pages 705-712

  Hajak, Göran ^a   Hedner, Jan ^b   Eglin, Mirjam ^c   Loft, Henrik ^c   Stórustovu, Signe í ^c   Lütolf, Simone ^c   Lundahl, Jonas ^c  

^a UNIVERSITY OF REGENSBURG   (Germany)

^b UNIVERSITY OF GOTHENBURG   (Sweden)

^c H LUNDBECK A S   (Denmark)

Author keywords

Daytime function; Extrasynaptic GABAA agonist (SEGA); Gaboxadol; Primary insomnia; Sleep maintenance; Sleep onset; Zolpidem

Indexed keywords

GABOXADOL; PLACEBO; ZOLPIDEM;

ADULT; AGED; AGITATION; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DEPRESSION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTRONIC MEDICAL RECORD; FEMALE; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NAUSEA AND VOMITING; OUTPATIENT; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SLEEP PARAMETERS; SOMNOLENCE; SYNCOPE; TREATMENT DURATION; VOMITING; WAKEFULNESS; WITHDRAWAL SYNDROME;

ADOLESCENT; ADULT; AGED; AMBULATORY CARE; AUTOMATIC DATA PROCESSING; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GABA AGONISTS; HUMANS; ISOXAZOLES; MALE; MIDDLE AGED; PYRIDINES; QUESTIONNAIRES; SEVERITY OF ILLNESS INDEX; SINGLE-BLIND METHOD; SLEEP INITIATION AND MAINTENANCE DISORDERS; SUBSTANCE WITHDRAWAL SYNDROME; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 67650573197     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2008.09.010     Document Type: Article

References (37)

1. Ohayon M.M. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev 6 (2002) 97-111
2. Morin C.M., Bootzin R.R., Buysse D.J., Edinger J.D., Espie C.A., and Lichstein K.L. Psychological and behavioral treatment of insomnia: update of the recent evidence (1998-2004). Sleep 29 (2006) 1398-1414
3. A receptor: an old target with new potential?. Sleep Med 5 Suppl. 1 (2004) S9-S15
4. A receptor subtypes. Adv Pharmacol 54 (2006) 231-263
5. A receptors. Proc Natl Acad Sci USA 100 (2003) 14439-14444
6. A receptors and their activation by GABA spillover in the mouse dentate gyrus. J Neurosci 23 (2003) 10650-10661
7. Brickley S.G., Revilla V., Cull-Candy S.G., Wisden W., and Farrant M. Adaptive regulation of neuronal excitability by a voltage-independent potassium conductance. Nature 409 (2001) 88-92
8. A receptors responsible for tonic and phasic conductances. Neurochem Res 26 (2001) 907-913
9. Wafford K.A., and Ebert B. Gaboxadol - a new awakening in sleep. Curr Opin Pharmacol 6 (2006) 30-36
10. A agonist, gaboxadol, improves traditional hypnotic efficacy measures and enhances slow wave activity in a model of transient insomnia. Sleep 30 (2007) 593-602
11. A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med 2008;9:393-402.
12. Deacon S., Staner L., Staner C., Legters A., Loft H., and Lundahl J. Effect of short-term treatment with gaboxadol on sleep maintenance and initiation in patients with primary insomnia. Sleep 30 (2007) 281-287
13. Lundahl J, Staner L, Staner C, et al. Short-term treatment with gaboxadol improves sleep maintenance and enhances slow wave sleep in adult patients with primary insomnia. Psychopharmacology (Berl) 2007;195:139-46.
14. EMEA. Note for Guidance, Clinical Investigation of Hypnotic Medicinal Products. 1992;III/3855/89.
15. Fry J., Scharf M., Mangano R., and Fujimori M. Zaleplon improves sleep without producing rebound effects in outpatients with insomnia. Zaleplon clinical study group. Int Clin Psychopharmacol 15 (2000) 141-152
16. 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
17. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. text revision (DSM-IV-TR). Washington DC: American Psychiatric Association; 2000.
18. Sheehan D., Janavs J., Baker R., Harnett-Sheehan K., Knapp E., and Sheehan M. Mini-International Neuropsychiatric Interview (M.I.N.I.). J Clin Psychiatry 60 Suppl. 18 (1999) 39-62
19. Ott H, Oswald I, Fichte K, et al. VIS-A und VIS-M. In: J.W.S. Angus (Ed.), Collegium Internationale Psychiatriae Scalarum. Internationale Skalen für Psychiatrie Göttingen: Beltz Test GmbH; 1996. p. 141-5.
20. Parrott A.C., and Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl) 71 (1980) 173-179
21. Tyrer P., Murphy S., and Riley P. The benzodiazepine Withdrawal Symptom Questionnaire. J Affect Disord 19 (1990) 53-61
22. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75 (1988) 800-802
23. Lund J., Lundahl J., Nielsen G.M., and Mengel H. The pharmacokinetic properties of gaboxadol, a new hypnotic, in young and elderly men. Sleep 28 Suppl. (2005) A48
24. Drover D.R. Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clin Pharmacokinet 43 (2004) 227-238
25. A agonist THIP produces slow wave sleep and reduces spindling activity in NREM sleep in humans. Psychopharmacology (Berl) 130 (1997) 285-291
26. A agonist gaboxadol on nocturnal sleep and hormone secretion in healthy elderly subjects. Am J Physiol Endocrinol Metab 281 (2001) E130-E137
27. A agonist gaboxadol improves the quality of post-nap sleep. Psychopharmacology (Berl) 157 (2001) 299-304
28. Mathias S., Zihl J., Steiger A., and Lancel M. Effect of repeated gaboxadol administration on night sleep and next-day performance in healthy elderly subjects. Neuropsychopharmacology 30 (2005) 833-841
29. Walsh J.K., Snyder E., Randazzo A., Griffin K., Eisenstein R., Schweitzer P., et al. Gaboxadol enhances slow wave sleep and reduces daytime sleepiness during sleep restriction. Sleep 30 (2007) A121-A122
30. National Institute of Health State-of-the-Science Conference Statement. Manifestations and management of chronic insomnia in adults. Sleep 2005; 28: 1049-1057.
31. Anderson A. Zopiclone and nitrazepam: a multicentre placebo-controlled comparative study of efficacy and tolerance in insomniac patients in general practice. Sleep 10 Suppl. 1 (1987) 54-62
32. Hajak G., Clarenbach P., Fischer W., Haase W., and Ruther E. Zopiclone improves sleep quality and daytime well-being in insomniac patients: comparison with triazolam, flunitrazepam and placebo. Int Clin Psychopharmacol 9 (1994) 251-261
33. Krystal A.D., Walsh J.K., Laska E., Caron J., Amato D.A., Wessel T.C., 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 (2003) 793-799
34. Roth T., Walsh J.K., Krystal A., Wessel T., and Roehrs T.A. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med 6 (2005) 487-495
35. Roth T., Wright Jr. K.P., and Walsh J. Effect of tiagabine on sleep in elderly subjects with primary insomnia: a randomized, double-blind, placebo-controlled study. Sleep 29 (2006) 335-341
36. Roth T., Soubrane C., Titeux L., and Walsh J.K. Efficacy and safety of zolpidem-MR: a double-blind, placebo-controlled study in adults with primary insomnia. Sleep Med 7 (2006) 397-406
37. Roth T., Seiden D., Sainati S., Wang-Weigand S., Zhang J., and Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med 7 (2006) 312-318