The effect of treatment with melatonin on primary school aged children with difficulty in initiation and maintenance of sleep.

Jalilolghadr S, Roozmehr S, Yazdi Z, Soltanabadi M. The effect of treatment with melatonin on primary school aged children with difficulty in initiation and maintenance of sleep. Turk J Pediatr. 2022;64(6):993-1000. doi:10.24953/turkjped.2018.1381

Overview

This double-blind randomized clinical trial included 60 children ages 7-12 with reported sleep issues. The children were given either 3 mg of melatonin [DM1] (tablet form) or a placebo for one month and re-evaluated after the supplementation. The melatonin-treated group had significant improvements in the initiation of sleep, sleep onset delay, sleep duration, sleep anxiety, nightly waking, parasomnias, and daily performance compared with the placebo group. 

Our clinical takeaway from the article

The use of melatonin in children for sleep concerns is a topic we have routinely examined, reported on, and reviewed as literature becomes available. We agree that other approaches, especially sleep hygiene, should be addressed first prior to melatonin therapy considering that endogenous production of melatonin is high in this age group. This short-term study does support existing literature that demonstrates the safety profile of melatonin in children, with a maximum dose of 3 mg for children and 5 mg for adolescents, in those who need it. The use of melatonin for children should always be discussed with the child’s physician before starting supplementation. 

Article summary

The children included in this study met the DSM-IV criteria for insomnia. The children’s sleep habits questionnaire (CSHQ) was completed by the children’s parents at the start and conclusion of the study. The participants were randomly assigned to receive either 3 mg of melatonin or placebo for one month, taken at 7 pm. Additionally, a daily sleep log was completed during this time. 

Based on the CSHQ, the following outcomes were statistically significant after one month of melatonin therapy:

• Sleep onset delay decreased (p=0.001)

• Duration of sleep improved (p=0.001)

• Sleep anxiety decreased (p=0.001)

• Nightly awakenings reduced (p=0.002)

• Parasomnias improved (p=0.001)

• Daily performance improved (p=0.002) 

Bedtime resistance increased, and sleep-disordered breathing decreased, both insignificantly (p>0.05). The melatonin-treated group did not report any side effects. 

Limitations Noted by Authors

No limitations of the double-blind, randomized clinical trial were noted; however, the authors remarked that some of the existing literature reviewed in this manuscript that aided in the development of their hypotheses included studies in which melatonin was used on children with developmental disorders.​

Other limitations noted by our review

• Though it was noted that sleep hygiene should be addressed before melatonin therapy, details on this aspect of care were not reported

• The short duration of one month for the study

• The authors noted that the exact dosage of melatonin for children has not been established, referring to studies in which the dosage ranged from 0.5 mg to 10 mg. It is not clear how or why the 3 mg dose was selected for this study. Safety data has suggested the maximum dose for children is 3 mg and for adolescents in 5 mg. 

• Uncertainty of how soon the 3 mg dose of melatonin began providing benefits, as data was only collected at the start and end of the study.

• Would a reduced dose be effective for the reported outcomes? A possible future study could include a comparison of 0.3 mg and 3 mg dosing, keeping in mind the early published research of Dr. Wurtman et al. 

Article review completed by Kim Ross, DCN

Content reviewed by Deanna Minich, PhD

February 13, 2023