melatonin clinical studies

Melatonin Clinical Studies

Melatonin has been studied clinically for decades. Its efficacy and safety have been established by multiple studies worldwide. Below you will find links to the abstracts of key melatonin articles (for reference and medical education purposes only).

General Overview of Melatonin

Melatonin in Humans
The New England Journal of Medicine, 1997.

Sleep-Inducing Effects of Melatonin

Sleep-Inducing Effects of Low Doses of Melatonin Ingested in the Evening
(Harvard Medical School and MIT)
Clinical Pharmacology & Therapeutics, 1995.

Effects of Exogenous Melatonin on Sleep: A Meta-Analysis
(MIT, Boston University School of Medicine, University of Glasgow, UK, and Hadassah Medical Center, Israel)
Sleep Medicine Reviews, 2005.

Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders
(Yale University, Children’s Hospital of Michigan, and University of São Paulo Medical School)
PLOS One, 2013.

Prolonged-Release Melatonin

Prolonged-Release Melatonin Improves Sleep Quality and Morning Alertness in Insomnia Patients Aged 55 Years and Older and Has No Withdrawal Effects
(The Clinique Lyon-Lumière, France; Neurim Pharmaceuticals, Israel; Tel Aviv University, Israel)
Journal of Sleep Research, 2007.

Prolonged-Release Melatonin for Insomnia – An Open-Label Long-Term Study of Efficacy, Safety, and Withdrawal
(The Clinique Lyon- Lumière, France; Shoham Geriatric Medical Center, Israel; Neurim Pharmaceuticals, Israel; Tel Aviv University, Israel)
Therapeutics and Clinical Risk Management, 2011.


Nightly Treatment of Primary Insomnia with Prolonged Release Melatonin for 6 Months: A Randomized Placebo Controlled Trial on Age and Endogenous Melatonin as Predictors of Efficacy and Safety
(University of Glasgow, UK; Tel Aviv University, Israel; and CPS Research, UK)
BMC Medicine, 2010.