Trial reportJournal of sleep research2020
Respiratory safety of lemborexant in healthy adult and elderly subjects with mild obstructive sleep apnea: A randomized, double-blind, placebo-controlled, crossover study.
Trial report in Journal of sleep research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06928766 (Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea), which is not on this map. Cited by 16 papers, 3 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.
Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Comparative effects of hypnotic agents on sleep architecture and respiratory outcomes in obstructive sleep apnea: A systematic review and network meta-analysis.Psychiatry and clinical neurosciences · 2026Pooled it
- Hypnotics on Obstructive Sleep Apnea Severity and Endotypes: A Systematic Review and Meta-Analysis.American journal of respiratory and critical care medicine · 2024Pooled it
- Proposal for Managing Cancer-Related Insomnia: A Systematic Literature Review of Associated Factors and a Narrative Review of Treatment.Cancer medicine · 2024Pooled it
- Respiratory safety of lemborexant in adult and elderly subjects with moderate-to-severe chronic obstructive pulmonary disease.Journal of sleep research · 2025Trial
- A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024Trial
- Respiratory Safety of Lemborexant in Healthy Subjects: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Crossover Study.Clinical drug investigation · 2021Trial
- Respiratory safety of lemborexant in healthy adult and elderly subjects with mild obstructive sleep apnea: A randomized, double-blind, placebo-controlled, crossover study.Journal of sleep research · 2020Trial
- Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea.Sleep medicine: X · 2026Article
- Found in translation: orexin receptor antagonism for the treatment of opioid use disorder.Translational psychiatry · 2025Review
- The effect of the initial administration of suvorexant on severe sleep apnea syndrome.Sleep and biological rhythms · 2025Article
- Impact of zolpidem and lemborexant on sleep and morning symptoms when used as a single dose for polysomnography.Sleep and biological rhythms · 2024Article
- The abuse potential of lemborexant, a dual orexin receptor antagonist, according to the 8 factors of the Controlled Substances Act.Psychopharmacology · 2023Review
- Current Update on Clinically Relevant Sleep Issues in Parkinson's Disease: A Narrative Review.Journal of Parkinson's disease · 2021Review
- An Update on Assessment, Therapeutic Management, and Patents on Insomnia.BioMed research international · 2021Review
- Advances in the Treatment of Chronic Insomnia: A Narrative Review of New Nonpharmacologic and Pharmacologic Therapies.Neuropsychiatric disease and treatment · 2021Review
- The Insomnia-Addiction Positive Feedback Loop: Role of the Orexin System.Frontiers of neurology and neuroscience · 2021Review
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 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lemborexant is a dual orexin receptor antagonist indicated for the treatment of adult and elderly individuals with insomnia. Some current pharmacologic treatments for insomnia cause respiratory depression, a serious safety concern, particularly for individuals with obstructive sleep apnea (OSA). This phase 1, randomized, double-blind, placebo-controlled, two-period crossover study examined respiratory safety parameters in individuals with mild OSA following treatment with lemborexant. Participants (n = 39) were randomized to one of two treatment sequences, including placebo and lemborexant 10 mg. Each treatment period lasted 8 days and was separated by a washout of at least 14 days. Following single or multiple doses, there were no significant differences in mean apnea-hypopnea index for lemborexant 10 mg versus placebo (least squares mean [LSM] difference [95% confidence interval {CI}]: day 1, -0.03 [-2.22, 2.17]; day 8, -0.06 [-1.95, 1.83]) or peripheral capillary oxygen saturation during sleep (LSM difference [95% CI]: day 1, 0.07 [-0.31, 0.46]; day 8, 0.25 [-0.11, 0.61]). There were no significant differences versus placebo for the percentage of total sleep time during which peripheral capillary oxygen saturation was <80% (LSM difference [95% CI]: day 1, 0.002 [-0.019, 0.023]; day 8, 0.006 [-0.015, 0.026]), <85% (LSM difference [95% CI]: day 1, 0.067 [-0.124, 0.258]; day 8, 0.056 [-0.117, 0.228]) or <90% (LSM difference [95% CI]: day 1, 0.312 [-0.558, 1.181]; day 8, 0.088 [-0.431, 0.607]). The incidence of treatment-emergent adverse events was low and similar for lemborexant and placebo. Lemborexant demonstrated respiratory safety in this study population and was well tolerated.
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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.