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

Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy.
Journal of the American Geriatrics Society (Impact Factor: 4.57). 01/2011; 59(1):82-90. DOI: 10.1111/j.1532-5415.2010.03232.x
Source: PubMed


To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long-term care facility residents.
Double-blind, placebo-controlled clinical trial.
One long-term care facility in Pavia, Italy.
Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3 ± 3.9.
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.
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.
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.
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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    • "The role of melatonin in the aging process is not well understood. Even so, nightly melatonin supplementation, alone or combined with magnesium (which also improves measures of insomnia),49 has been shown to improve sleep disturbance in older adults50–52 as well as to diminish symptoms of REM sleep behavior disorder.53 These findings suggest a potential therapeutic role for melatonin in treating sleep disturbance symptoms in older individuals. "
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    ABSTRACT: Maintaining a stable and adequate sleeping pattern is associated with good health and disease prevention. As a restorative process, sleep is important for supporting immune function and aiding the body in healing and recovery. Aging is associated with characteristic changes to sleep quantity and quality, which make it more difficult to adjust sleep–wake rhythms to changing environmental conditions. Sleep disturbance and abnormal sleep–wake cycles are commonly reported in seriously ill older patients in the intensive care unit (ICU). A combination of intrinsic and extrinsic factors appears to contribute to these disruptions. Little is known regarding the effect that sleep disturbance has on health status in the oldest of old (80+), a group, who with diminishing physiological reserve and increasing prevalence of frailty, is at a greater risk of adverse health outcomes, such as cognitive decline and mortality. Here we review how sleep is altered in the ICU, with particular attention to older patients, especially those aged 80 years. Further work is required to understand what impact sleep disturbance has on frailty levels and poor outcomes in older critically ill patients.
    Clinical Interventions in Aging 06/2014; 9:969. DOI:10.2147/CIA.S59927 · 2.08 Impact Factor
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    • "In particular, melatonin seems to produce a possible antidepressant effect [20, 21]—probably due to the action it performs on the central circadian regulation [22]—and also to improve cognitive functions [23, 24]. "
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    ABSTRACT: The aim of this article was to perform a systematic review on the role of melatonin in the prevention of cancer tumorigenesis-in vivo and in vitro-as well as in the management of cancer correlates, such as sleep-wake and mood disturbances. The International Agency for Research on Cancer recently classified "shift-work that involves circadian disruption" as "probably carcinogenic to humans" (Group 2A) based on "limited evidence in humans for the carcinogenicity of shift-work that involves night-work", and "sufficient evidence in experimental animals for the carcinogenicity of light during the daily dark period (biological night)". The clinical implications and the potential uses of melatonin in terms of biologic clock influence (e.g. sleep and mood), immune function, cancer initiation and growth, as well as the correlation between melatonin levels and cancer risk, are hereinafter recorded and summarized. Additionally, this paper includes a description of the newly discovered effects that melatonin has on the management of sleep-wake and mood disturbances as well as with regard to cancer patients' life quality. In cancer patients depression and insomnia are frequent and serious comorbid conditions which definitely require a special attention. The data presented in this review encourage the performance of new clinical trials to investigate the possible use of melatonin in cancer patients suffering from sleep-wake and mood disturbances, also considering that melatonin registered a low toxicity in cancer patients.
    Aging - Clinical and Experimental Research 09/2013; 25(5). DOI:10.1007/s40520-013-0118-6 · 1.22 Impact Factor
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    • "Sleep is regulated by circadian and homeostatic processes [8]; however, it is still a matter of debate whether MLT indirectly regulates sleep through the control of circadian processes such as body temperature or modulates the activity of brain nuclei directly involved in the regulation of sleep. Several human [9] [10] [11] and animal [12] [13] studies have shown hypnotic properties of exogenous MLT, but others have failed to demonstrate these effects [14] [15]. Methodological (dosage, time of administration, monitoring of the wake-sleep cycle) as well as chemical properties of MLT (short half life 40 min [16]) can partially explain such contrasting findings. "
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    ABSTRACT: The neurohormone melatonin activates two G-protein coupled receptors, MT(1) and MT(2). Melatonin is implicated in circadian rhythms and sleep regulation, but the role of its receptors remains to be defined. We have therefore characterized the spontaneous vigilance states in wild-type (WT) mice and in three different types of transgenic mice: mice with genetic inactivation of MT(1) (MT(1)(-/-)), MT(2) (MT(2)(-/-)) and both MT(1)/MT(2) (MT(1)(-/-)/MT(2)(-/-)) receptors. Electroencephalographic (EEG) and electromyographic sleep-wake patterns were recorded across the 24-h light-dark cycle. MT(1)(-/-)mice displayed a decrease (-37.3%) of the 24-h rapid eye movement sleep (REMS) time whereas MT(2)(-/-)mice showed a decrease (-17.3%) of the 24-h non rapid eye movement sleep (NREMS) time and an increase in wakefulness time (14.8%). These differences were the result of changes occurring in particular during the light/inactive phase. Surprisingly, MT(1)(-/-)/MT(2)(-/-) mice showed only an increase (8.9%) of the time spent awake during the 24-h. These changes were correlated to a decrease of the REMS EEG theta power in MT(1)(-/-)mice, of the NREMS EEG delta power in MT(2)(-/-)mice, and an increase of the REMS and wakefulness EEG theta power in MT(1)(-/-)/MT(2)(-/-) mice. Our results show that the genetic inactivation of both MT(1) and MT(2) receptors produces an increase of wakefulness, likely as a result of reduced NREMS due to the lack of MT(2) receptors, and reduced REMS induced by the lack of MT(1) receptors. Therefore, each melatonin receptor subtype differently regulates the vigilance states: MT(2) receptors mainly NREMS whereas MT(1) receptors REMS.
    Behavioural brain research 01/2013; 243(1). DOI:10.1016/j.bbr.2013.01.008 · 3.03 Impact Factor
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