Hoever, P. and Dorffner, G. and Benes, H. and Penzel, T. and Danker-Hopfe, H. and Barbanoj, M. J. and Pillar, G. and Saletu, B. and Polo, O. and Kunz, D. and Zeitlhofer, J. and Berg, S. and Partinen, M. and Bassetti, C. L. and Hoegl, B. and Ebrahim, I. O. and Holsboer-Trachsler, E. and Bengtsson, H. and Peker, Y. and Hemmeter, U-M and Chiossi, E. and Hajak, G. and Dingemanse, J. (2012) Orexin Receptor Antagonism, a New Sleep-Enabling Paradigm: A Proof-of-Concept Clinical Trial. CLINICAL PHARMACOLOGY & THERAPEUTICS, 91 (6). pp. 975-985. ISSN 0009-9236, 1532-6535
Full text not available from this repository. (Request a copy)Abstract
The orexin system is a key regulator of sleep and wakefulness. In a multicenter, double-blind, randomized, placebo-controlled, two-way crossover study, 161 primary insomnia patients received either the dual orexin receptor antagonist almorexant, at 400, 200, 100, or 50 mg in consecutive stages, or placebo on treatment nights at 1-week intervals. The primary end point was sleep efficiency (SE) measured by polysomnography; secondary end points were objective latency to persistent sleep (LPS), wake after sleep onset (WASO), safety, and tolerability. Dose-dependent almorexant effects were observed on SE, LPS, and WASO. SE improved significantly after almorexant 400 mg vs. placebo (mean treatment effect 14.4%; P < 0.001). LPS (-18 min (P = 0.02)) and WASO (-54 min (P < 0.001)) decreased significantly at 400 mg vs. placebo. Adverse-event incidence was dose-related. Almorexant consistently and dose-dependently improved sleep variables. The orexin system may offer a new treatment approach for primary insomnia.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HYPOCRETIN OREXIN; REBOUND INSOMNIA; HYPNOTIC DRUGS; EFFICACY; NARCOLEPSY; SAFETY; PEPTIDES; ZOLPIDEM; PLACEBO; OREXIN/HYPOCRETIN; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 13 May 2020 06:26 |
| Last Modified: | 13 May 2020 06:26 |
| URI: | https://pred.uni-regensburg.de/id/eprint/18676 |
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