Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2021
Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02783729 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Are sleep disturbances modifiable risk factors for mild cognitive impairment and dementia? A systematic review of large studies.Sleep & breathing = Schlaf & Atmung · 2025Pooled it
- Comparison of efficacy and safety of dual orexin receptor antagonists lemborexant and daridorexant for the treatment of insomnia: a systematic review and meta-analysis.Psychopharmacology · 2025Pooled it
- Respiratory safety of lemborexant in adult and elderly subjects with moderate-to-severe chronic obstructive pulmonary disease.Journal of sleep research · 2025Trial
- Trial
- Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study.Nature and science of sleep · 2024Trial
- Sleep regulates drug seeking and relapse - a perspective.Molecular psychiatry · 2026Review
- Pharmacological modulation of hyperarousal in insomnia associated with major depressive disorder: a narrative review of sedating antidepressants and orexin receptor antagonists.Frontiers in psychiatry · 2026Review
- Effect of lemborexant on sleep-wake state discrepancy in participants with insomnia disorder.Psychopharmacology · 2026Article
- Sleep Architecture Alterations Following High-Dose Steroid Pulse Therapy: A Pilot Study Using a Portable Electroencephalogram-Based Device.Neuropsychopharmacology reports · 2025Article
- The new science of sleep: From cells to large-scale societies.PLoS biology · 2024Article
- Safety and Efficacy of Lemborexant in Insomnia Patients: Results of a Postmarketing Observational Study of DayvigoDrugs in R&D · 2024Observational
- Treatment Modalities for Insomnia in Adults Aged 55 and Older: A Systematic Review of Literature from 2018 to 2023.Current sleep medicine reports · 2024Article
- The effect of lemborexant on insomnia in patients with psychiatric disorders: Detailed evaluation using the Athens Insomnia Scale.PCN reports : psychiatry and clinical neurosciences · 2024Article
- Emerging and upcoming therapies in insomnia.Translational and clinical pharmacology · 2024Article
- 2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults - Brazilian Sleep Association.Sleep science (Sao Paulo, Brazil) · 2023Review
- Daridorexant, a Recently Approved Dual Orexin Receptor Antagonists (DORA) in Treatment of Insomnia.Sleep science (Sao Paulo, Brazil) · 2023Article
- Orexin Receptor Antagonists and Insomnia.Current psychiatry reports · 2022Review
- Advances in the Treatment of Chronic Insomnia: A Narrative Review of New Nonpharmacologic and Pharmacologic Therapies.Neuropsychiatric disease and treatment · 2021Review
- Evaluation of SAMP8 Mice as a Model for Sleep-Wake and Rhythm Disturbances Associated with Alzheimer's Disease: Impact of Treatment with the Dual Orexin (Hypocretin) Receptor Antagonist Lemborexant.Journal of Alzheimer's disease : JAD · 2021Article
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 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesChanges to sleep architecture that occur as a result of the normal aging process may also exacerbate insomnia in older individuals. Therefore, this study assessed the impact of lemborexant compared with placebo and zolpidem tartrate extended release on objective sleep architecture parameters, as measured by polysomnography, in older adults (ages ≥ 55 years) with insomnia disorder from a phase 3 study.
methodsStudy E2006-G000-304 (SUNRISE 1; NCT02783729) was a global, multicenter, randomized, double-blind, placebo-controlled, active comparator (zolpidem)-controlled, parallel-group study comparing 2 dose levels of lemborexant (5 mg and 10 mg). Sleep architecture was measured using polysomnography. Assessments were collected at baseline during a single-blind placebo run-in and during the first 2 nights and last 2 nights of treatment. Mean values for each sleep stage were based on the 2 consecutive polysomnograms.
resultsTreatment with lemborexant resulted in significantly greater increases from baseline in total sleep time compared with both placebo and zolpidem. Significant increases from baseline in rapid eye movement sleep and significant decreases from baseline in latency to rapid eye movement sleep were also observed with lemborexant compared with placebo and zolpidem.
conclusionsThese findings suggest that treatment with lemborexant may address some of the alterations in sleep architecture normally observed in older individuals with insomnia. CLINICAL
trial registrationRegistry: ClinicalTrials.gov; Name: Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1); URL: https://clinicaltrials.gov/ct2/show/NCT02783729; Identifier: NCT02783729.
Indexed as
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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.