Objectives: To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in residents of long-term care facilities.
Design: Double-blind, placebo-controlled clinical trial.
Location: A long-term care facility in Pavia, Italy.
Participants: Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group), 78.3 ± 3.9 years old.
Intervention: Participants took a dietary supplement (5 mg melatonin, 225 mg magnesium, and 11.25 mg zinc, mixed with 100 g pear pulp) or placebo (100 g pear pulp) every day for 8 weeks, 1 hour before bedtime.
Measurements: The primary objective was to assess sleep quality using the Pittsburgh Sleep Quality Index. The Epworth Sleepiness Scale, Leeds Sleep Evaluation Questionnaire (LSEQ), Short Insomnia Questionnaire (SDQ), and a validated quality of life measure (Medical Outcomes Study 36-item Short Form Survey (SF-36)) were administered as secondary endpoints. Total sleep time was assessed using a wearable wristband sensor. All measurements were taken at baseline and after 60 days.
Results: The dietary supplement resulted in a significantly better overall PSQI score than placebo (between-group difference from baseline PSQI score = 6.8; 95% confidence interval = 5.4-8.3, P<0.001). In addition, significant improvements were seen in all four domains of the LSEQ (ease of falling asleep, P<0.001; sleep quality, P<0.001; hangover upon awakening from sleep, P=0.005; alertness and behavioral integrity, P=.001), SDQ score (P<0.001), total sleep time (P<0.001), and SF-36 physical score (P=0.006), suggesting that the treatment had a beneficial effect on the restorative value of sleep.
Conclusion: Nightly administration of melatonin, magnesium, and zinc appears to improve sleep quality and quality of life in people living in long-term care facilities with primary insomnia.
Source: https://pubmed.ncbi.nlm.nih.gov/21226679/
