Optimization of Melatonin Administration in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mel 2 mg 30 min, Mel 2 mg 3 h, Mel 4 mg 30 min, Mel 4 mg 3 h.
- Who it may be relevant to
- Registry conditions: Sleep Disorders. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optimizing Timing and Dose of Melatonin Administration: a Randomized, Double-blind Controlled Trial in Healthy Adults
Overview
The goal of this clinical trial is to evaluate whether the timing and dosage of exogenous melatonin can improve sleep onset and maintenance in healthy adults aged 18-45 years (50% female) with no history of sleep disorders. The main questions it aims to answer is whether an optimized melatonin administration schedule (4 mg, 3 hours before bedtime) will be more effective in improving sleep initiation and maintenance than an administration schedule more commonly advised (2 mg, 30 minutes before bedtime). Researchers will compare five conditions involving different combinations of melatonin or placebo administered 30 minutes or 3 hours before bedtime to see if earlier timing and/or higher dosage produces better sleep outcomes. Participants will: * Complete a habituation night without any intervention. * Undergo five randomized, double-blind experimental sleep conditions including: 2 mg melatonin 30 minutes before bedtime 2 mg melatonin 3 hours before bedtime 4 mg melatonin 30 minutes before bedtime 4 mg melatonin 3 hours before bedtime Placebo at both time points * Be monitored via polysomnography to measure sleep parameters
Interventions
- Dietary supplement Mel 2 mg 30 min
Melatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime - Dietary supplement Mel 2 mg 3 h
Placebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime - Dietary supplement Mel 4 mg 30 min
Melatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime - Dietary supplement Mel 4 mg 3 h
Placebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime - Other Placebo
Placebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Primary outcome measures
- Sleep Onset Latency [Time frame: First night following administration of the drug]
Secondary outcome measures (3)
- Total Sleep Time [Time frame: First night following administration of the drug]
- Sleep Efficiency [Time frame: First night following administration of the drug]
- Wake After Sleep Onset [Time frame: First night following administration of the drug]
Eligibility criteria
Inclusion criteria
- Age between 18 and 45 years of age
- Fluent knowledge of Italian language
- Review and signing of the informed consent form
Exclusion criteria
- Diagnosis of sleep or circadian rhythm disorder
- Diagnosis of neurological, psychiatric or medical condition that may interfere with sleep
- Ongoing treatment with medications that may affect sleep, including hypnotics and other types of melatonin
- Travel to a country with a time zone difference of at least two hours within the two months prior to or during the study
- Shift work
- Confirmed pregnancy
- Breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- University of Pisa, Institute of Physiology, Sonnolab — Pisa
Publications
- Bruno S, Cenerini G, Lo Giudice L, Cruz-Sanabria F, Benedetti D, Crippa A, Fiori S, Ferri R, Masi G, Faraguna U. Optimizing timing and dose of exogenous melatonin administration in neuropsychiatric pediatric populations: a meta-analysis on sleep outcomes. Sleep Med Rev. 2025 Dec;84:102158. doi: 10.1016/j.smrv.2025.102158. Epub 2025 Aug 30. PMID 40914024
- Cruz-Sanabria F, Bruno S, Crippa A, Frumento P, Scarselli M, Skene DJ, Faraguna U. Optimizing the Time and Dose of Melatonin as a Sleep-Promoting Drug: A Systematic Review of Randomized Controlled Trials and Dose-Response Meta-Analysis. J Pineal Res. 2024 Aug;76(5):e12985. doi: 10.1111/jpi.12985. PMID 38888087
Identifiers
NCT: NCT07514507 · 0043072/2023