✓ Translated by DotMD AI Clinical Council Source: Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #37677076 ↗

Randomized Controlled Trial: A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea (N = 33)

Original Paper Title: “A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 33
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • LEM10 demonstrated respiratory safety and was well tolerated with single-dose and multiple-dose administration in participants with moderate to severe OSA. This suggests that LEM may be a treatment option for patients with OSA and comorbid insomnia.
  • Study Design & Sample: Randomized Controlled Trial published in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine (N = 33 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine (2024), this randomized controlled trial evaluating 33 human participants investigated: To evaluate the respiratory safety of lemborexant among adults and older adults with moderate to severe obstructive sleep apnea (OSA). Key clinical takeaway: LEM10 demonstrated respiratory safety and was well tolerated with single-dose and multiple-dose administration in participants with moderate to severe OSA. This suggests that LEM may be a treatment option for patients with OSA and comorbid insomnia.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2024-01-01; N = 33; Rigor 88/100): LEM10 demonstrated respiratory safety and was well tolerated with single-dose and multiple-dose administration in participants with moderate to severe OSA. This suggests that LEM may be a treatment option for patients with OSA and comorbid insomnia.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Randomized Controlled Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: lemborexant → Rx: severe-congestion-and-cough-max-dextromethorphan-hbr-guaifenesin → Rx: night-time-severe-cold-and-cough-relief-acetaminophen-diphenhydramine → Condition: sleep-apnea → Condition: circadian-rhythm-sleep-disorder-delayed-sleep-phase-type → Condition: circadian-rhythm-sleep-disorder-irregular-sleep-wake-type →
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