✓ Translated by DotMD AI Clinical Council Source: Journal of sleep research • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #8795804 ↗

Randomized Controlled Trial: Melatonin and insomnia (N = 15)

Original Paper Title: “Melatonin and insomnia”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 15
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Side-effects attributed to melatonin included headache and an odd taste in the mouth. These data indicate that melatonin is probably of no clinical value in the management of psychophysiological insomnia.
  • Study Design & Sample: Randomized Controlled Trial published in Journal of sleep research (N = 15 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 sleep research (1996), this randomized controlled trial evaluating 15 human participants investigated: The hypnotic action of melatonin 5 mg p.o. Key clinical takeaway: Side-effects attributed to melatonin included headache and an odd taste in the mouth. These data indicate that melatonin is probably of no clinical value in the management of psychophysiological insomnia.

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

Primary Endpoint & Quantitative Summary (Journal of sleep research, 1996-03-15; N = 15; Rigor 88/100): Side-effects attributed to melatonin included headache and an odd taste in the mouth. These data indicate that melatonin is probably of no clinical value in the management of psychophysiological 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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