Trial reportSleep2012
The orexin antagonist SB-649868 promotes and maintains sleep in men with primary insomnia.
Trial report in Sleep, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03312517 (A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects), which is not on this map. Cited by 32 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.
A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
Who cites it
32 citing papers in PubMed, 86 citations in OpenAlex.
- Cannabinol for Acute Treatment of Insomnia Disorder in a Randomized Placebo-Controlled Crossover Trial.Journal of sleep research · 2026Trial
- Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep?Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 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
- Genetic associations between orexin genes and phenotypes related to behavioral regulation in humans, including substance use.Molecular psychiatry · 2025Article
- Cannabinoid and Orexigenic Systems Interplay as a New Focus of Research in Alzheimer's Disease.International journal of molecular sciences · 2024Review
- Effects of new hypnotic drugs on cognition: A systematic review and network meta-analysis.Sleep medicine: X · 2023Review
- Orexin Signaling: A Complex, Multifaceted Process.Frontiers in cellular neuroscience · 2022Review
- Orexin dual receptor antagonists, zolpidem, zopiclone, eszopiclone, and cognitive research: A comprehensive dose-response meta-analysis.Frontiers in human neuroscience · 2022Review
- Hypocretin/Orexin Receptor Pharmacology and Sleep Phases.Frontiers of neurology and neuroscience · 2021Review
- Orexin Receptor Antagonists as Emerging Treatments for Psychiatric Disorders.Neuroscience bulletin · 2020Review
- A New Positron Emission Tomography Probe for Orexin Receptors Neuroimaging.Molecules (Basel, Switzerland) · 2020Article
- Hypnotics with novel modes of action.British journal of clinical pharmacology · 2020Review
- An Update on Dual Orexin Receptor Antagonists and Their Potential Role in Insomnia Therapeutics.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2018Review
- Molecular Evolutionary Analysis of the HCRTR Gene Family in Vertebrates.BioMed research international · 2018Article
- Selective Inhibition of Orexin-2 Receptors Prevents Stress-Induced ACTH Release in Mice.Frontiers in behavioral neuroscience · 2017Article
- Inhibition of Orexin Signaling Promotes Sleep Yet Preserves Salient Arousability in Monkeys.Sleep · 2016Article
- The hypocretin/orexin system in sleep disorders: preclinical insights and clinical progress.Nature and science of sleep · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo assess the acute effects of SB-649868 in male subjects with Primary Insomnia with regard to (1) objective and subjective sleep parameters, (2) safety and tolerability, (3) next-day residual effects.
designMulticenter, randomized, double-blind, placebo-controlled crossover study using a complete set of Williams orthogonal Latin Squares
setting9 sleep centers in Germany PATIENTS: 52 male subjects with a diagnosis of primary insomnia (difficulty in sleep initiation and maintenance) confirmed by polysomnography
interventionsSB-649868 (10, 30, 60 mg) and placebo administered after dinner 90 minutes before bedtime MEASUREMENTS AND
resultsSleep effects assessed by polysomnography during 2 consecutive nights and by sleep questionnaires completed by subjects after each night at the sleep laboratory. Safety and tolerability were assessed by adverse events collection, electrocardiogram (ECG), vital signs, laboratory tests. Next-day residual effects were assessed by Digit Symbol Substitution Test, and modified Verbal Learning Memory Test administered at "lights on" after night 2. SB-649868 significantly reduced latency to persistent sleep, wake after sleep onset (WASO), and increased total sleep time (TST) compared to placebo. A dose-dependent effect was observed. A dose-dependent increase in absolute and percent REM sleep and reduction in REM sleep latency was observed mainly at the 60-mg dose. SB-649868 was well tolerated with inconsistent next day residual effects. SB-649868 sleep effects were correlated with SB-649868 circulating levels.
conclusionThe data demonstrate the sleep-promoting properties of the orexin antagonist SB-649868 in male patients with insomnia.
Indexed as
Identifiers
What OpenQuestion holds
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.