A randomized Phase 2 study to evaluate the orexin-2 receptor antagonist seltorexant in individuals with insomnia without psychiatric comorbidity

Journal of Psychopharmacology
Peter De BoerRemy Luthringer

Abstract

Seltorexant is a potent and selective antagonist of the orexin-2 receptor that is being developed for the treatment of insomnia and major depressive disorder. The primary objective was to investigate the effect of seltorexant on sleep efficiency after single and multiple dose administration in subjects with insomnia disorder without psychiatric comorbidity. Secondary objectives included evaluation of total sleep time, latency to persistent sleep, and wake after sleep onset. Subjects received 40 mg of seltorexant for five days during Period 1 and placebo during Period 2 or vice versa in this randomized, two-way crossover study. Objective sleep parameters were evaluated by polysomnography over 8 h on Day 1/2 (single dose) and on Day 5/6 (multiple doses). Subjective sleep parameters were assessed by questionnaires. Twenty-seven subjects completed the study. The mean changes in sleep efficiency (% (SD)) of seltorexant from placebo at Day 1/2 were 5.8 (9.2), and 7.9 (9.8) at Day 5/6 ( p < 0.001 at both time points); in total sleep time (min (SD)) 27.7 (44.3) and 37.9 (47.1), respectively; in latency to persistent sleep (min (SD)) -18.8 (21.3) and -29.9 (27.7), respectively; and in wake after sleep onset (min (SD)) -11.1 (36.4) and -...Continue Reading

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Citations

Sep 10, 2020·Expert Opinion on Drug Metabolism & Toxicology·Clemens MuehlanJasper Dingemanse
Jul 17, 2019·Bioorganic & Medicinal Chemistry Letters·Younggi Choi, Brian K Raymer
Mar 13, 2021·Expert Opinion on Pharmacotherapy·Gary Zammit, Andrew Krystal
Mar 13, 2021·Translational Research : the Journal of Laboratory and Clinical Medicine·Mark K GreenwaldTimothy A Roehrs
Oct 11, 2021·Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology·Victoria L RevellDerk-Jan Dijk
Jan 20, 2022·Journal of Internal Medicine·Laura H JacobsonLuis de Lecea

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Clinical Trials Mentioned

NCT02464046

Software Mentioned

Cogstate

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