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

Background: 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. Aims: The primary objective was to investigate the effect of seltorexant on sleep efficiency after single and multiple dose admin...

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Published in:Journal of psychopharmacology (Oxford) 2018-06, Vol.32 (6), p.668-677
Main Authors: De Boer, Peter, Drevets, Wayne C, Rofael, Hany, van der Ark, Peter, Kent, Justine M, Kezic, Iva, Parapatics, Silvia, Dorffner, Georg, van Gerven, Joop, Beneš, Heike, Keicher, Christian, Jahn, Holger, Seiden, David J, Luthringer, Remy
Format: Article
Language:English
Subjects:
Adult
Comorbidity
Cross-Over Studies
Double-Blind Method
Efficiency
Female
Headache
Headache - chemically induced
Humans
Insomnia
Latency
Male
Mental depression
Middle Aged
Orexin Receptor Antagonists - administration & dosage
Orexin Receptor Antagonists - adverse effects
Orexin Receptor Antagonists - therapeutic use
Orexin Receptors - drug effects
Orexin Receptors - metabolism
Orexins
Polysomnography
Pyrimidines - administration & dosage
Pyrimidines - adverse effects
Pyrimidines - therapeutic use
Pyrroles - administration & dosage
Pyrroles - adverse effects
Pyrroles - therapeutic use
Randomization
Sleep - drug effects
Sleep and wakefulness
Sleep disorders
Sleep Initiation and Maintenance Disorders - drug therapy
Sleepiness
Surveys and Questionnaires
Time Factors
Treatment Outcome
Triazoles - administration & dosage
Triazoles - adverse effects
Triazoles - therapeutic use
Young Adult
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Summary:Background: 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. Aims: 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. Results: 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 −11.3 (46.5). The most common adverse events were headache and somnolence. Conclusions: Sleep efficiency was increased with seltorexant treatment compared with placebo. Treatment with seltorexant resulted in a prolonged total sleep time, shorter latency to persistent sleep and wake after sleep onset. There were no unexpected safety findings.
ISSN:0269-8811
1461-7285
DOI:10.1177/0269881118773745