Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs

Summary

Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (responsivity) of Belsomra 10 mg and 20 mg to Placebo in non-elderly Insomniacs

Timeline

Start

2018-04-15

Primary completion

2018-10-25

Completion

2018-10-25

Publications

• Background Greenblatt DJ, Harmatz JS, Shader RI. Update on Psychotropic Drug Prescribing in the United States: 2014-2015. J Clin Psychopharmacol. 2018 Feb;38(1):1-4. doi: 10.1097/JCP.0000000000000831. No abstract available.
• Background Bonnet MH, Webb WB, Barnard G. Effect of flurazepam, pentobarbital, and caffeine on arousal threshold. Sleep. 1979 Spring;1(3):271-9. doi: 10.1093/sleep/1.3.271.
• Background Johnson LC, Church MW, Seales DM, Rossiter VS. Auditory arousal thresholds of good sleepers and poor sleepers with and without flurazepam. Sleep. 1979 Spring;1(3):259-70. doi: 10.1093/sleep/1.3.259.
• Background Johnson LC, Spinweber CL, Webb SC, Muzet AG. Dose level effects of triazolam on sleep and response to a smoke detector alarm. Psychopharmacology (Berl). 1987;91(4):397-402. doi: 10.1007/BF00216003.
• Background Drake CL, Durrence H, Cheng P, Roth T, Pillai V, Peterson EL, Singh M, Tran KM. Arousability and Fall Risk During Forced Awakenings From Nocturnal Sleep Among Healthy Males Following Administration of Zolpidem 10 mg and Doxepin 6 mg: A Randomized, Placebo-Controlled, Four-Way Crossover Trial. Sleep. 2017 Jul 1;40(7). doi: 10.1093/sleep/zsx086.
• Background Bettica P, Squassante L, Zamuner S, Nucci G, Danker-Hopfe H, Ratti E. The orexin antagonist SB-649868 promotes and maintains sleep in men with primary insomnia. Sleep. 2012 Aug 1;35(8):1097-104. doi: 10.5665/sleep.1996.
• Background Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.
• Background Michelson D, Snyder E, Paradis E, Chengan-Liu M, Snavely DB, Hutzelmann J, Walsh JK, Krystal AD, Benca RM, Cohn M, Lines C, Roth T, Herring WJ. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. doi: 10.1016/S1474-4422(14)70053-5. Epub 2014 Mar 27.
• Background Tannenbaum PL, Stevens J, Binns J, Savitz AT, Garson SL, Fox SV, Coleman P, Kuduk SD, Gotter AL, Marino M, Tye SJ, Uslaner JM, Winrow CJ, Renger JJ. Orexin receptor antagonist-induced sleep does not impair the ability to wake in response to emotionally salient acoustic stimuli in dogs. Front Behav Neurosci. 2014 May 16;8:182. doi: 10.3389/fnbeh.2014.00182. eCollection 2014.
• Background Tannenbaum PL, Tye SJ, Stevens J, Gotter AL, Fox SV, Savitz AT, Coleman PJ, Uslaner JM, Kuduk SD, Hargreaves R, Winrow CJ, Renger JJ. Inhibition of Orexin Signaling Promotes Sleep Yet Preserves Salient Arousability in Monkeys. Sleep. 2016 Mar 1;39(3):603-12. doi: 10.5665/sleep.5536.
• Background Manber R, Harvey A. Historical perspective and future directions in Cognitive Behavioral Therapy for insomnia and behavioral sleep medicine. Clin Psychol Rev. 2005 Jul;25(5):535-8. doi: 10.1016/j.cpr.2005.04.002. No abstract available.
• Background Allen RP, Burchell BJ, MacDonald B, Hening WA, Earley CJ. Validation of the self-completed Cambridge-Hopkins questionnaire (CH-RLSq) for ascertainment of restless legs syndrome (RLS) in a population survey. Sleep Med. 2009 Dec;10(10):1097-100. doi: 10.1016/j.sleep.2008.10.007. Epub 2009 Feb 4.
• Background Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
• Background Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
• Background Keefe FB, Johnson LC, Hunter EJ. EEG and autonomic response pattern during waking and sleep stages. Psychophysiology. 1971 Mar;8(2):198-212. doi: 10.1111/j.1469-8986.1971.tb00451.x. No abstract available.
• Background Spinweber CL, Johnson LC. Effects of triazolam (0.5 mg) on sleep, performance, memory, and arousal threshold. Psychopharmacology (Berl). 1982;76(1):5-12. doi: 10.1007/BF00430746.
• Background Bruck D, Thomas IR. Smoke alarms for sleeping adults who are hard-of-hearing: comparison of auditory, visual, and tactile signals. Ear Hear. 2009 Feb;30(1):73-80. doi: 10.1097/AUD.0b013e3181906f89.
• Background Rosenthal L, Bishop C, Helmus T, Krstevska S, Roehrs T, Roth T. Auditory awakening thresholds in sleepy and alert individuals. Sleep. 1996 May;19(4):290-5. doi: 10.1093/sleep/19.4.290.
• Background Busby KA, Mercier L, Pivik RT. Ontogenetic variations in auditory arousal threshold during sleep. Psychophysiology. 1994 Mar;31(2):182-8. doi: 10.1111/j.1469-8986.1994.tb01038.x.
• Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, Singh M, Tonnu CV, Fellman-Couture C. Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep? J Clin Sleep Med. 2019 Sep 15;15(9):1285-1291. doi: 10.5664/jcsm.7920.

Drugs

Indications