Effects of suvorexant on sleep architecture and power spectral profile in patients with insomnia: Analysis of pooled phase 3 data

Sleep Medicine

Volumn 19, Issue , 2016, Pages 93-100

  Snyder, Ellen ^a   Ma, Junshui ^a   Svetnik, Vladimir ^a   Connor, Kathryn M ^a   Lines, Christopher ^a   Michelson, David ^a   Herring, W Joseph ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Orexin; Polysomnography; Power spectral density; Sleep architecture; Suvorexant

Indexed keywords

PLACEBO; SUVOREXANT; AZEPINE DERIVATIVE; OREXIN RECEPTOR ANTAGONIST; TRIAZOLE DERIVATIVE;

ADULT; AGED; ARTICLE; BETA RHYTHM; DATA ANALYSIS; DELTA RHYTHM; DRUG EFFECT; FEMALE; GAMMA RHYTHM; HUMAN; INSOMNIA; LATENT PERIOD; MAJOR CLINICAL STUDY; MALE; NONREM SLEEP; PHASE 3 CLINICAL TRIAL (TOPIC); POLYSOMNOGRAPHY; POWER SPECTRUM; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REM SLEEP; SLEEP; SLEEP ARCHITECTURE; SLEEP TIME; SLOW WAVE SLEEP; CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECTS; ELECTROENCEPHALOGRAPHY; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SLEEP STAGE;

AZEPINES; ELECTROENCEPHALOGRAPHY; FEMALE; HUMANS; MALE; MIDDLE AGED; OREXIN RECEPTOR ANTAGONISTS; POLYSOMNOGRAPHY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SLEEP INITIATION AND MAINTENANCE DISORDERS; SLEEP STAGES; TRIAZOLES;

EID: 84959200360     PISSN: 13899457     EISSN: 18785506     Source Type: Journal    
DOI: 10.1016/j.sleep.2015.10.007     Document Type: Article

References (28)

1. Roehrs T., Roth T. Insomnia pharmacotherapy. Neurother 2012, 9(4):728-738.
2. Sakurai T., Mieda M., Tsujino N. The orexin system: roles in sleep/wake regulation. Ann N Y Acad Sci 2010, 1200:149-161.
3. Taheri S., Sunter D., Dakin C., et al. Diurnal variation in orexin A immunoreactivity and prepro-orexin mRNA in the rat central nervous system. Neurosci Lett 2000, 279(2):109-112.
4. Zeitzer J.M., Buckmaster C.L., Parker K.J., et al. Circadian and homeostatic regulation of hypocretin in a primate model: implications for the consolidation of wakefulness. J Neurosci 2003, 23(8):3555-3560.
5. Brisbare-Roch C., Dingemanse J., Koberstein R., et al. Promotion of sleep by targeting the orexin system in rats, dogs and humans. Nat Med 2007, 13(2):150-155.
6. Gotter A.L., Roecker A.J., Hargreaves R., et al. Orexin receptors as therapeutic drug targets. Prog Brain Res 2012, 198:163-188.
7. Cox C.D., Breslin M.J., Whitman D.B., et al. Discovery of the dual orexin receptor antagonist [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2H -1,2,3-triazol-2-yl)phenyl]methanone (MK-4305) for the treatment of insomnia. J Med Chem 2010, 53(14):5320-5332.
8. Winrow C.J., Gotter A.L., Cox C.D., et al. Promotion of sleep by suvorexant-a novel dual orexin receptor antagonist. J Neurogenet 2011, 25(1-2):52-61.
9. Sun H., Kennedy W.P., Wilbraham D., et al. Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men. Sleep 2013, 36(2):259-267.
10. Herring W.J., Snyder E., Budd K., et al. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology 2012, 79(23):2265-2274.
11. Michelson D., Snyder E., Paradis E., et al. Safety and efficacy of suvorexant, an orexin receptor antagonist, during 1-year treatment of insomnia followed by abrupt discontinuation of treatment: a randomized, double-blind, placebo-controlled clinical trial. Lancet Neurol 2014, 13:461-471.
12. Herring W.J., Connor K.M., Ivgy-May N., et al. Suvorexant in patients with insomnia: results from two 3-month randomized controlled clinical trials. Biol Psychiatry 2016, 79(2):136-148.
13. Rechtschaffen A., Kales A.E. A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects 1968, Public Health Service, US Government Printing Office, Washington DC.
14. Iber C., Ancoli-Israel S., Chesson A., et al. The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications 2007, American Academy of Sleep Medicine, Westchester.
15. Brunner D.P., Dijk D.J., Münch M., et al. Effect of zolpidem on sleep and sleep EEG spectra in healthy young men. Psychopharmacology (Berl) 1991, 104(1):1-5.
16. Scharf M.B., Roth T., Vogel G.W., et al. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry 1994, 55(5):192-199.
17. Bettica P., Squassante L., Zamuner S., et al. The orexin antagonist SB-649868 promotes and maintains sleep in men with primary insomnia. Sleep 2012, 35(8):1097-1104.
18. Hoever P., Dorffner G., Benes H., et al. Orexin receptor antagonism, a new sleep-enabling paradigm: a proof-of-concept clinical trial. Clin Pharmacol Ther 2012, 91(6):975-985.
19. Bastien C.H. Insomnia: neurophysiological and neuropsychological approaches. Neuropsychol Rev 2011, 21(1):22-40.
20. Ma J., Svetnik V., Snyder E., et al. Electroencephalographic power spectral density profile of the orexin receptor antagonist suvorexant in patients with primary insomnia and healthy subjects. Sleep 2014, 37(10):1609-1619.
21. American Psychiatric Association Diagnostic and statistical manual of mental disorders 2000, American Psychiatric Association, Washington, D.C., Text Revision. 4th ed.
22. Ma J., Dijk D.J., Svetnik V., et al. EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. J Clin Sleep Med 2011, 7(5):493-501A.
23. Baglioni C., Regen W., Teghen A., et al. Sleep changes in the disorder of insomnia: a meta-analysis of polysomnographic studies. Sleep Med Rev 2014, 18(3):195-213.
24. Svetnik V., Snyder E.S., Ivgy-May N., et al. Comparison of PSG sleep parameters, microstructure and spectral profiles, between patients with primary insomnia and good sleeper controls using a large compilation of PSG recordings from three clinical trials. Sleep 2014, 37:A204. Abstract 0585.
25. Liblau R.S., Vassalli A., Seifinejad A., et al. Hypocretin (orexin) biology and the pathophysiology of narcolepsy with cataplexy. Lancet Neurol 2015, 14(3):318-328.
26. Farkas R. FDA presentations for the May 22, 2013 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee accessed 01.05.15. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/ucm346581.htm.
27. Singh M., Drake C.L., Roth T. The prevalence of multiple sleep-onset REM periods in a population-based sample. Sleep 2006, 29(7):890-895.
28. Struyk A., Gargano C., Drexel M., et al. Pharmacodynamic effects of suvorexant and zolpidem on electroencephalographic spectral density during sleep in healthy volunteers. Sleep 2015, 38(Suppl.):A233. Abstract 0666.