Trial reportClinical pharmacology and therapeutics2012
Orexin receptor antagonism, a new sleep-enabling paradigm: a proof-of-concept clinical trial.
Trial report in Clinical pharmacology and therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 126 citations in OpenAlex.
- Trial
- First-in-human study with ACT-539313, a novel selective orexin-1 receptor antagonist.British journal of clinical pharmacology · 2020Trial
- Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019Trial
- Interaction potential of the dual orexin receptor antagonist ACT-541468 with CYP3A4 and food: results from two interaction studies.European journal of clinical pharmacology · 2019Trial
- Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder.The international journal of neuropsychopharmacology · 2017Trial
- A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia.The international journal of neuropsychopharmacology · 2016Trial
- Orexin 2 Receptor Antagonism is Sufficient to Promote NREM and REM Sleep from Mouse to Man.Scientific reports · 2016Trial
- Trial
- Assessment of the abuse liability of a dual orexin receptor antagonist: a crossover study of almorexant and zolpidem in recreational drug users.CNS drugs · 2014Trial
- Formulation development for the orexin receptor antagonist almorexant: assessment in two clinical studies.Drug design, development and therapy · 2014Trial
- Absence of pharmacokinetic and pharmacodynamic interactions between almorexant and warfarin in healthy subjects.Drugs in R&D · 2013Trial
- Almorexant effects on CYP3A4 activity studied by its simultaneous and time-separated administration with simvastatin and atorvastatin.European journal of clinical pharmacology · 2013Trial
- Current and novel dual orexin receptor antagonists for the treatment of insomnia: the emergence of vornorexant.The international journal of neuropsychopharmacology · 2025Review
- Neuropeptidergic systems in psychiatric disorders.Frontiers in endocrinology · 2025Review
- The Underlying Mechanisms of Sleep Deprivation Exacerbating Neuropathic Pain.Nature and science of sleep · 2023Review
- Orexin Receptor Antagonists and Insomnia.Current psychiatry reports · 2022Review
- Pharmacokinetics of daridorexant, a dual orexin receptor antagonist, are not affected by renal impairment.Clinical and translational science · 2021Article
- Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia.Psychopharmacology · 2021Review
- Effect of Liver Cirrhosis on the Pharmacokinetics, Metabolism, and Tolerability of Daridorexant, A Novel Dual Orexin Receptor Antagonist.Clinical pharmacokinetics · 2021Article
- Hypocretin (Orexin) Replacement Therapies.Medicine in drug discovery · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 16 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.