Abstract | OBJECTIVE: METHODS: Data were pooled from two similar Phase 3, randomized, double-blind, placebo-controlled, parallel-group, three-month trials in elderly (≥65 years) and non-elderly (18-64 years old) insomnia patients. Age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg were evaluated. The ISI, a 7-item self-rated questionnaire with each item rated on 0-4 scale (higher score corresponds to increasing severity), was administered to patients as an exploratory assessment in both studies at baseline and one and three months after randomization. RESULTS: The analysis included 1824 patients. Suvorexant improved change-from-baseline ISI total scores to a greater extent than placebo (Month three: 20/15 mg = -6.2, 40/30 mg = -6.7, placebo = -4.9, p-values for both active arms vs. placebo <0.001) and resulted in a greater proportion of responders than placebo using a variety of definitions (eg, ≥6-point improvement from baseline at Month three: 20/15 mg = 55.5%, 40/30 mg = 54.9%, placebo = 42.2%, p-values for both active arms vs. placebo <0.001). Additionally, the "impact of insomnia" component, which assesses the impact of insomnia on daytime function/quality-of-life, was improved to a greater extent by suvorexant than placebo. CONCLUSIONS:
Suvorexant 20/15 mg and 40/30 mg improved sleep to a greater extent than placebo as assessed by the ISI in patients with insomnia. Improvement in sleep onset/maintenance as well as a reduction of the impact of sleep problems on daytime function contributed to the overall improvement observed in ISI total score. CLINICALTRIALS. GOV IDENTIFIER: NCT01097616, NCT01097629.
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Authors | W Joseph Herring, Kathryn M Connor, Ellen Snyder, Duane B Snavely, Charles M Morin, Christopher Lines, David Michelson |
Journal | Sleep medicine
(Sleep Med)
Vol. 56
Pg. 219-223
(04 2019)
ISSN: 1878-5506 [Electronic] Netherlands |
PMID | 30522875
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2018 Elsevier B.V. All rights reserved. |
Chemical References |
- Azepines
- Orexin Receptor Antagonists
- Triazoles
- suvorexant
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Topics |
- Adolescent
- Adult
- Aged
- Azepines
(administration & dosage, pharmacology)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Orexin Receptor Antagonists
(administration & dosage, pharmacology)
- Outcome Assessment, Health Care
- Severity of Illness Index
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Triazoles
(administration & dosage, pharmacology)
- Young Adult
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