Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
Summary
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.
Timeline
- Start
- 2010-05-05
- Primary completion
- 2011-09-09
- Completion
- 2011-12-07
Outcome
Met primary endpoint
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p <0.00001; Difference in Least Squares Means 19.6 (95% CI 12.0 to 27.1) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p <0.00001; Difference in Least Squares Means 19.7 (95% CI 11.9 to 27.6) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p <0.00001; Difference in Least Squares Means -26.3 (95% CI -33.5 to -19.2) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p <0.00001; Difference in Least Squares Means -22.9 (95% CI -30.3 to -15.4) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p = 0.00298; Difference in Least Squares Means -7.4 (95% CI -12.3 to -2.5) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p = 0.00019; [Difference in Least Squares Means -8.4 (95% CI -12.8 to -4.0) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p = 0.00002; Difference in Least Squares Means -11.2 (95% CI -16.3 to -6.1) NCT01097616 ↗
registry analysis (superiority or other test); Suvorexant HD vs Placebo; p = 0.00037; Difference in Least Squares Means -9.4 (95% CI -14.6 to -4.3) NCT01097616 ↗
paper Suvorexant 40/30 mg was superior to placebo on all subjective and polysomnography end points PMID 25526970 ↗
Publications
- Results Herring WJ, Connor KM, Ivgy-May N, Snyder E, Liu K, Snavely DB, Krystal AD, Walsh JK, Benca RM, Rosenberg R, Sangal RB, Budd K, Hutzelmann J, Leibensperger H, Froman S, Lines C, Roth T, Michelson D. Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry. 2016 Jan 15;79(2):136-48. doi: 10.1016/j.biopsych.2014.10.003. Epub 2014 Oct 23.
- Tao P, Svetnik V, Bliwise DL, Zammit G, Lines C, Herring WJ. Comparison of polysomnography in people with Alzheimer's disease and insomnia versus non-demented elderly people with insomnia. Sleep Med. 2023 Jan;101:515-521. doi: 10.1016/j.sleep.2022.11.027. Epub 2022 Dec 1.
- Snyder ES, Tao P, Svetnik V, Lines C, Herring WJ. Use of the single-item Patient Global Impression-Severity scale as a self-reported assessment of insomnia severity. J Sleep Res. 2021 Feb;30(1):e13141. doi: 10.1111/jsr.13141. Epub 2020 Jul 30.
- Svetnik V, Snyder ES, Tao P, Roth T, Lines C, Herring WJ. How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients? Sleep Med. 2020 Mar;67:137-146. doi: 10.1016/j.sleep.2019.08.020. Epub 2019 Sep 11.
- Herring WJ, Connor KM, Snyder E, Snavely DB, Morin CM, Lines C, Michelson D. Effects of suvorexant on the Insomnia Severity Index in patients with insomnia: analysis of pooled phase 3 data. Sleep Med. 2019 Apr;56:219-223. doi: 10.1016/j.sleep.2018.09.010. Epub 2018 Oct 2.
- Svetnik V, Snyder ES, Tao P, Scammell TE, Roth T, Lines C, Herring WJ. Insight Into Reduction of Wakefulness by Suvorexant in Patients With Insomnia: Analysis of Wake Bouts. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx178.
- Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.
- Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. Psychopharmacology (Berl). 2017 Jun;234(11):1703-1711. doi: 10.1007/s00213-017-4573-1. Epub 2017 Mar 7.
- Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials. J Clin Sleep Med. 2016 Sep 15;12(9):1215-25. doi: 10.5664/jcsm.6116.
- Snyder E, Ma J, Svetnik V, Connor KM, Lines C, Michelson D, Herring WJ. Effects of suvorexant on sleep architecture and power spectral profile in patients with insomnia: analysis of pooled phase 3 data. Sleep Med. 2016 Mar;19:93-100. doi: 10.1016/j.sleep.2015.10.007. Epub 2015 Nov 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suvorexant | Small molecule | 15 mg | Oral |
| Subject | Suvorexant | Small molecule | 20 mg | Oral |
| Subject | Suvorexant | Small molecule | 30 mg | Oral |
| Subject | Suvorexant | Small molecule | 40 mg | Oral |