Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2012
Differential effects of a dual orexin receptor antagonist (SB-649868) and zolpidem on sleep initiation and consolidation, SWS, REM sleep, and EEG power spectra in a model of situational insomnia.
Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
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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.
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Who cites it
42 citing papers in PubMed, 94 citations in OpenAlex.
- Doxepin is more effective than zolpidem in improving executive function in patients with insomnia disorder.Sleep & breathing = Schlaf & Atmung · 2024Trial
- Effects of the selective orexin-2 receptor antagonist JNJ-48816274 on sleep initiated in the circadian wake maintenance zone: a randomised trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022Trial
- Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021Trial
- 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
- Orexin 2 Receptor Antagonism is Sufficient to Promote NREM and REM Sleep from Mouse to Man.Scientific reports · 2016Trial
- Trial
- Neuroendocrine and sympathetic responses to an orexin receptor antagonist, SB-649868, and alprazolam following insulin-induced hypoglycemia in humans.Psychopharmacology · 2014Trial
- The orexin antagonist SB-649868 promotes and maintains sleep in men with primary insomnia.Sleep · 2012Trial
- Wake-promoting neuromodulators in Alzheimer's disease: Implications for sleep and brain clearance.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Review
- Neuropeptidergic systems in psychiatric disorders.Frontiers in endocrinology · 2025Review
- Dispensing of zolpidem and benzodiazepines in Brazilian private pharmacies: a retrospective cohort study from 2014 to 2021.Frontiers in pharmacology · 2024Article
- Altered Sleep Oscillations as Neurophysiological Biomarkers of Schizophrenia.Advances in neurobiology · 2024Review
- All-night spectral and microstate EEG analysis in patients with recurrent isolated sleep paralysis.Frontiers in neuroscience · 2024Article
- An examination of sleep spindle metrics in the Sleep Heart Health Study: superiority of automated spindle detection over total sigma power in assessing age-related spindle decline.BMC neurology · 2023Article
- Pedunculopontine-induced cortical decoupling as the neurophysiological locus of dissociation.Psychological review · 2023Article
- Dual Orexin Receptor Antagonists (DORAs) as an Adjunct Treatment for Smoking Cessation.CNS drugs · 2022Article
- Exploring the Role of Orexinergic Neurons in Parkinson's Disease.Neurotoxicity research · 2021Review
- Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia.Psychopharmacology · 2021Review
- Hypocretin/Orexin Receptor Pharmacology and Sleep Phases.Frontiers of neurology and neuroscience · 2021Review
- Advances in the Treatment of Chronic Insomnia: A Narrative Review of New Nonpharmacologic and Pharmacologic Therapies.Neuropsychiatric disease and treatment · 2021Review
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Orexins have a role in sleep regulation, and orexin receptor antagonists are under development for the treatment of insomnia. We conducted a randomised, double-blind, placebo-controlled, four-period crossover study to investigate the effect of single doses of the dual orexin receptor antagonist SB-649868 (10 or 30 mg) and a positive control zolpidem (10 mg), an allosteric modulator of GABA(A) receptors. Objective and subjective sleep parameters and next-day performance were assessed in 51 healthy male volunteers in a traffic noise model of situational insomnia. Compared with placebo, SB-649868 10 and 30 mg increased total sleep time (TST) by 17 and 31 min (p<0.001), whereas after zolpidem TST was increased by 11.0 min (p=0.012). Wake after sleep onset was reduced significantly by 14.7 min for the SB-6489698 30 mg dose (p<0.001). Latency to persistent sleep was significantly reduced after both doses of SB-6489698 (p=0.003), but not after zolpidem. Slow wave sleep (SWS) and electroencephalogram (EEG) power spectra in non-REM sleep were not affected by either dose of SB-640868, whereas SWS (p< 0.001) and low delta activity (<=1.0 Hz) were increased, and 2.25-11.0 Hz activity decreased after zolpidem. REM sleep duration was increased after SB-649868 30 mg (p=0.002) and reduced after zolpidem (p=0.049). Latency to REM sleep was reduced by 20.1 (p=0.034) and 34.0 min (p<0.001) after 10 and 30 mg of SB-649868. Sleep-onset REM episodes were observed. SB-649868 was well tolerated. This dual orexin receptor antagonist exerts hypnotic activity, with effects on sleep structure and the EEG that are different from those of zolpidem.
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