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✓ Translated by DotMD AI Clinical Council Source: Sleep medicine • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #16309958 ↗

Randomized Controlled Trial: An efficacy, safety, and dose-response study of Ramelteon in patients with chronic primary insomnia (N = 107)

Original Paper Title: “An efficacy, safety, and dose-response study of Ramelteon in patients with chronic primary insomnia”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 107
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Ramelteon demonstrated a statistically significant reduction in LPS and a statistically significant increase in TST, with no apparent next-day residual effects, in patients with chronic primary insomnia.
  • Study Design & Sample: Randomized Controlled Trial published in Sleep medicine (N = 107 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Sleep medicine (2006), this randomized controlled trial evaluating 107 human participants investigated: To evaluate the efficacy, safety, and dose response of Ramelteon, a novel highly selective MT1/MT2 receptor agonist, in patients with chronic primary insomnia. Key clinical takeaway: Ramelteon demonstrated a statistically significant reduction in LPS and a statistically significant increase in TST, with no apparent next-day residual effects, in patients with chronic primary insomnia.

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

Primary Endpoint & Quantitative Summary (Sleep medicine, 2006-01-15; N = 107; Rigor 88/100): Ramelteon demonstrated a statistically significant reduction in LPS and a statistically significant increase in TST, with no apparent next-day residual effects, in patients with chronic primary 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.

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