The effect of melatonin, magnesium, and zinc on primary insomnia in long-term care facility residents in Italy: A double-blind, placebo-controlled clinical trial
Abstract
OBJECTIVES: To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long-term care facility residents. DESIGN: Double-blind, placebo-controlled clinical trial. SETTING: One long-term care facility in Pavia, Italy. PARTICIPANTS: Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3 ± 3.9. INTERVENTION: Participants took a food supplement (5 mg melatonin, 225 mg magnesium, and 11.25 mg zinc, mixed with 100 g of pear pulp) or placebo (100 g pear pulp) every day for 8 weeks, 1 hour before bedtime. MEASUREMENTS: The primary goal was to evaluate sleep quality using the Pittsburgh Sleep Quality Index. The Epworth Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire (LSEQ), the Short Insomnia Questionnaire (SDQ), and a validated quality-of-life instrument (Medical Outcomes Study 36-item Short Form Survey (SF-36)) were administered as secondary end points. Total sleep time was evaluated using a wearable armband-shaped sensor. All measures were performed at baseline and after 60 days. RESULTS: The food supplement resulted in considerably better overall PSQI scores than placebo (difference between groups in change from baseline PSQI score=6.8; 95% confidence interval=5.4-8.3, P<.001). Moreover, the significant improvements in all four domains of the LSEQ (ease of getting to sleep, P<.001; quality of sleep, P<.001; hangover on awakening from sleep, P=.005; alertness and behavioral integrity the following morning, P=.001), in SDQ score (P<.001), in total sleep time (P<.001), and in SF-36 physical score (P=.006) suggest that treatment had a beneficial effect on the restorative value of sleep. CONCLUSION: The administration of nightly melatonin, magnesium, and zinc appears to improve the quality of sleep and the quality of life in long-term care facility residents with primary insomnia.
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A food-based supplement containing 5 mg melatonin, 225 mg magnesium, and 11.25 mg zinc significantly improved subjective sleep quality scores and total sleep duration in older adults (n = 43).
“A placebo controlled double blind study on older adults (n = 43), demonstrated a food based supplement containing 5 mg melatonin, 225 mg magnesium and 11.25 mg zinc, significantly (p < 0.001) improved subjective sleep quality scores in the intervention group but not the controls (difference between the groups 6.8; 95% CI 5.4–8.3) and total sleep duration (182.18 min; 95% CI 160.02–204.34) assessed”
From Sleep and Nutrition Interactions: Implications for Athletes (2019) · cites this paper as [75]
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“The effects were attributed to the synergy between magnesium, zinc and melatonin [75].”
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- Authors
- Rondanelli, M., Opizzi, A., Monteferrario, F., Antoniello, N., Manni, R., & Klersy, C.
- Affiliations
- University of Pavia (IT)
- Venue
- Journal of the American Geriatrics Society
- Publisher
- Wiley
- Published
- 2011-01
- Volume
- 59
- Issue
- 1
- Pages
- 82-90
- ISSN
- 0002-8614 (ISSN-L)
- 1532-5415
- OpenAlex
- W2127276935
- Cited by
- 126
- References
- 52
- Citations by year
- 2026: 4 · 2025: 11 · 2024: 14 · 2023: 12 · 2022: 5 · 2021: 9 · 2020: 11 · 2019: 8 · 2018: 7 · 2017: 11 · 2016: 2 · 2015: 7 · 2014: 7 · 2013: 8 · 2012: 6
- FWCI
- 9.92
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the American Geriatrics Society (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Health Sciences › Nursing › Nutrition and Dietetics › Magnesium in Health and Disease
- Keywords
- primary insomnia, melatonin, magnesium, zinc, dietary supplementation, long-term care residents, sleep quality, quality of life, older adults, total sleep time, sleepiness
- MeSH terms
- Aged, Central Nervous System Depressants, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Sleep Initiation and Maintenance Disorders, Italy, Long-Term Care, Magnesium, Male, Melatonin, Nursing Homes, Quality of Life, Zinc, Dietary Supplements, Intention to Treat Analysis
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