How Safe And Effective Is Melatonin For Kids?

Melatonin for kids: When should you use melatonin for kids? What dose should you use? How frequently should you use melatonin for kids? What are the side effects of Melatonin?

Because melatonin is a very commonly used non-prescription medicine, knowing how safe and effective it is, is essential.

What is Melatonin?

Melatonin is a normal hormone in our body. It is released by the pineal gland, a small gland present in the brain that regulates the day-night circadian rhythm.

Melatonin is released in the body in response to darkness. Hence it is usually released at night and its main action is to regulate the sleep cycle.

It reduces the time to sleep after going to bed, reduces nighttime awakening, and enhances sleep quality.

Since a good night’s sleep promotes physical and mental well-being, melatonin indirectly improves performance at school, relieves fatigue and depression, and improves quality of life.

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How Effective is Melatonin for Kids?

Melatonin is available OTC in different strengths and formulations. The efficacy of melatonin has been studied in different clinical randomized and non-randomized trials.

The results of these trials are summarized below:

Study of Melatonin 1 mg for schoolgoing kids:

The efficacy of melatonin for kids was evaluated in a randomized controlled trial in school-going children aged 14 to 19 years.

Melatonin was given in a dose of 1 mg in the afternoon between 04:30 pm and 6 pm. Students who were given melatonin in a dose of 1mg slept earlier and longer.

Students slept 68 minutes earlier and 62 minutes longer at week 5 compared to baseline. [Ref]

A retrospective study of Melatonin in children for insomnia:

In a retrospective study, Melatonin was given in a dose of 2 mg once daily 1 hour before sleep to children with a mean age of 9 years.

These children had problems with sleep initiation and maintenance. Melatonin reduced the sleep onset time and reduced the number of awakenings in 91% of the participants [Ref].

Melatonin for Chronic Sleep Onset Insomnia:

Melatonin was studied in 40 children aged between 6 and 12 years with chronic sleep onset insomnia.

Melatonin use in a dose of 5 mg improved light-out time, sleep onset, and sleep duration. However, there was no difference in the wake-up time and sustained attention compared to placebo [Ref].

Sleep onset insomnia was improved by 57 minutes in another study in children 6 to 12 years of age who were administered melatonin 5 mg daily [Ref].

Melatonin was effective in a dose of 0.05 mg/kg:

In a dose-finding study, Melatonin reduced sleep onset by about one hour.

Comparing melatonin doses, the authors concluded that melatonin in a dose of 0.05 mg/kg was effective in reducing the time to sleep onset when given 1 – 2 hours before sleep [Ref].

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How Safe is Melatonin for Kids:

Melatonin is considered a very safe medicine. Side effects are very rare except for mild degrees of fatigue and somnolence.

Some reports of melatonin-associated delayed puberty raised concerns among parents. However, subsequent studies did not find any association.

In one study conducted over a period of 3.1 years, melatonin in a mean dose of 2.6 mg did not result in delayed puberty in the Dutch population [Ref].

Safety with regard to delayed puberty was also confirmed in a study conducted in the Netherlands [Ref]

Some studies have linked sleep terrors when melatonin treatment is initiated, however, no serious adverse events were found with melatonin [Ref].

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Melatonin Use in Children [Ref]:

Primarily, melatonin is used for sleep disorders in children. Sleep disorders are further classified as:

Dyssomnias:

It is a disorder of difficulty in initiating or maintaining sleep. It is further classified as DSPS (delayed sleep-phase syndrome) and ASPS (advanced sleep-phase syndrome).

DSPS is a condition in which the child has difficulty falling asleep while ASPS is rare and children usually fall asleep earlier and wake up earlier.

Melatonin has been proven to improve sleep by reducing the onset of sleep after going to bed and maintaining sleep.

The effect of melatonin has been studied in lower doses of up to 0.05 mg/kg to higher doses of 0.15 mg/kg. It has been observed that even when administered at low doses, the effects were similar with the added benefits of minimal side effects.

Sleep disorders in mentally subnormal children:

Mentally subnormal individuals have more frequent sleep issues compared to normal children.

Conditions associated with sleep problems include Autism and autistic spectrum disorders, tuberous sclerosis, Angelman syndrome, and Rett syndrome among many others.

Melatonin in a dose of 0.5 to 9 mg has been proven to reduce sleep latency, the onset of sleep, and sleep awakening, and increase the total sleep time with minimal side effects.

Autism spectrum disorder:

Sleep problem is one of the primary concerns of children with autism spectrum disorders. Children with autism spectrum disorder have low melatonin levels compared to healthy children.

Melatonin in doses ranging from 3 to 10 mg has been proven to improve sleep quality and reduce the time to sleep onset.

In one study, melatonin was given in two formulations as 1 mg fast-release and 2 mg controlled-release in children with autism spectrum disorder.

The treatment was given for 12 to 24 months. Improvement in sleep was noted in all children. When the treatment was discontinued, 64% returned to their baseline sleep pattern [Ref].

Children with ADHD (attention-deficit hyperactive disorder):

Up to 50% of children with ADHD have sleep problems including difficulty falling asleep, maintaining sleep, waking up tired after sleep, and daytime sleepiness.

In one study, melatonin was given in a dose of 5 mg 20 minutes before bedtime. A significant reduction is sleep onset was noted compared to placebo [Ref].

Similarly, in another study, melatonin in a dose of 3 to 6 mg reduced sleep onset and increased total sleep time in individuals with ADHD and chronic sleep-onset insomnia [Ref].

The efficacy of Melatonin in children with ADHD has been reviewed in a recent meta-analysis.

The authors concluded their findings after analyzing 20 different randomized studies, review articles, and meta-analyses.

Melatonin was found to be an effective and safe treatment for chronic sleep-onset insomnia in children with ADHD [Ref].

Other uses of Melatonin in Children:

Melatonin has been studied in children with feeding disorders, febrile fits as well as epilepsy, neonatal sepsis, and anxiety during surgical procedures.

Although less effective than midazolam, it has been found to have beneficial effects compared to placebo with minimal side effects.

Melatonin is also being used for the management of benzodiazepines and nicotine withdrawal, cancer patients, migraine headaches, prevention of cluster headaches, chemo-related thrombocytopenia, jet lag, winter depression, and other conditions [Ref].

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Pediatric Melatonin Dose:

Melatonin has been used in different medical conditions associated with sleep disorders. In children, the dose ranged from as low as 0.5 mg to 10 mg per day.

In addition, it was observed that low doses were equally effective as higher doses. Hence most experts recommend initiating a low dose and titrating the dose according to the response and side effects.

In adults, the dose recommendations are as follows [Ref]:

Condition	Dose
Benzodiazepine Withdrawal in Elderly with Insomnia	2 mg controlled-release
Cancer, Adjunctive Therapy	10-50 mg
Prevention of Cluster Headache	10 mg PO
Migraine Headache	3 mg
Insomnia	3-5 mg
Chemo-related thrombocytopenia	20 mg
Jet Lag	0.5-5 mg
Chronic Fatigue Syndrome	5 mg
Nicotine Withdrawal	0.3 mg
Winter Depression	0.125 mg
Premedication for Surgery	0.5 mg/kg SL
Tardive Dyskinesia	10 mg