Melatonin Dosage for Children and Drug Interactions: Information to Guide Pharmacist Counseling

Melatonin Dosage for Children and Drug Interactions: Information to Guide Pharmacist Counseling

Melatonin Dosage for Children and Drug Interactions: Information to Guide Pharmacist CounselingIf you think of dietary supplements for children, gummy multivitamins might spring to mind first. Less often thought of, but still another top dietary supplement given to kids? Melatonin.

Because the supplement’s long-term safety hasn’t been studied, its use is a worrisome trend. Experts aren’t the first to raise a red flag, either—parents need only read the label. Most melatonin products carry a warning saying they shouldn’t be used by children under the age of 18. Pharmacists need to take a proactive stance, and reach out to parents about issues like dosage, interactions, and other ways to tackle their children’s sleep issues.

The Melatonin Trend

The use of melatonin rose from 0.1 percent of children in 2007 to 0.7 percent in 2012, which makes it the second most common non-vitamin supplement.1 Even though researchers haven’t pointed to cause-and-effect, some of the upward trend is likely due to the increasing prevalence of developmental disabilities—because children in this group commonly have sleep disorders. However, concerns about melatonin apply to all children, whatever their cognitive abilities, and right now, physicians are worried about its general overuse.

Melatonin is widely considered to be safe and effective, a belief that’s fostered by word of mouth, supported with a label saying it’s naturally made in the body, and legitimized by the fact that it’s an OTC dietary supplement. For the most part, it is safe when used properly and helps treat the following sleep disorders:

  • Sleep onset latency. Melatonin decreases sleep onset latency; the effect is greater in those with delayed sleep phase syndrome compared to those with primary insomnia.2
  • Delayed sleep-wake phase disorder. This occurs when sleep is delayed two or more hours beyond conventional bedtime. Circadian rhythms improve with strategically timed melatonin.
  • Comorbid insomnia in children with autism spectrum disorders. Sleep onset delays in children with autism may be related to variations in melatonin pathway genes, but melatonin effectively improves sleep initiation with minimal adverse effects.3
  • Non-24-hour sleep-wake rhythm disorder. Taking 0.3 to 3 milligrams about five hours before bedtime and at the correct circadian phase improves circadian rhythm. Chronic therapy is required in blind patients.
  • Sleep behavior disorder. Melatonin’s favorable adverse-effect profile makes it a good option over clonazepam, however no head-to-head trials of the two have been conducted.

Melatonin Dosage, Interactions and Adverse Effects

Doses of melatonin haven’t been studied in children, but researchers following kids with autism spectrum disorders use low doses for sedation—0.5 to 3 milligrams—given about 30 minutes before bedtime. When the goal is to treat circadian rhythm sleep disorders, the hormone is given at specific times during the day with the goal of shifting sleep onset. With a half-life less than an hour, it isn’t very effective for children who wake during the night, but parents may want to talk to their pediatrician about controlled-release melatonin.

Warnings and adverse effects: Parents should always consult their doctor before giving melatonin to children with psychiatric comorbidities, who have seizures or hypertension, or those taking immunosuppressive therapy. Adverse effects are seldom reported, but children may experience cramps, dizziness, headache or irritability. Warn parents that a larger dose isn’t necessarily better—they want to support the body’s natural system, not over-power it.

Interactions: Melatonin should not be mixed with sodium oxybate and its use should be closely watched with a list of 220 other medications.4 Medscape provides an interaction checker, but here a some of the pharmaceuticals on the list often prescribed for children. Notice that some on the list are commonly prescribed for children with developmental disabilities—prime patients for melatonin:

  • Albuterol
  • Dexmethylphenidate
  • Dextroamphetamine
  • Lisdexamfetamine
  • Ibuprofen
  • Clozapine
  • Haloperidol
  • Risperidone
  • Promethazine

Counseling Tips for Pharmacists

Parents need to know that melatonin is only considered safe for short-term use, primarily due to the utter lack of studies exploring its long-term impact. One study published in 2011 concluded melatonin could be used over a long period of time without “substantial deviation” of sleep quality, puberty development, and mental health. However, this conclusion was based on 48 children who took melatonin for a mean duration of 3.1 years—hardly a good measure of long-term safety.5

Many of the parents purchasing melatonin may not realize that it’s a hormone with other roles in the body beyond inducing sleep. It interacts with the immune system and works as an antioxidant. Low levels are associated with heart disease and epilepsy. Melatonin is an estrogen receptor antagonist and in animals it regulates reproductive cycles, which leads to concern over the potential for supplements to affect puberty. The point is that parents need to realize melatonin is a potent active ingredient.

It’s also important to be sure parents know that levels of melatonin fluctuate according to the amount of light perceived through the eyes and that it’s only released when the environment is dark. In other words, if their children want to sleep with lights on, or if they use cell phones, watch television, or use a computer or tablet before going to bed, their body will not produce and release enough melatonin to cause sleepiness. They should try implementing some of these steps before resorting to melatonin:

  • Dim house lights and turn off all electronics 30 minutes before bedtime—put kids to bed a half hour after cutting the lights to give melatonin time to surge.
  • Participate in calming activities, like reading a book using an LED light.
  • Keep a regular bedtime schedule and open curtains or blinds in the morning to let natural light regulate circadian rhythms.
  • Address any issues related to stress and anxiety to be sure they’re not affecting sleep.

Protect Your Youngest Patients with Proactive Outreach

It’s not easy to intervene when parents are purchasing melatonin for their children. They’re probably just as tired and frustrated as the kids and may bristle when you try to give advice. But this is vital information they need to know. Consider opening communication with a handout that gives a brief summary of melatonin concerns, or by asking if they’d like a free review of medications because melatonin may interact with common medications. Just be patient and don’t give up—you may be the only health care professional in a position to offer the help they need.

Pharmaceutica North America provides OTC products with melatonin, high-quality bulk APIs and prescription drug products. Contact us today to talk about how we can support all your pharmaceutical needs.

Show 5 footnotes

  1. “Use of Complementary Health Approaches Among Children Aged 4–17 Years in the United States: National Health Interview Survey, 2007–2012,” February 2015,
  2. “Melatonin for Sleep Onset Latency Outcome, Delayed Sleep-Wake Phase Disorder (DSWPD), Non-24-Hour Sleep-Wake Rhythm Disorder (N24SWD), and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD),” March 2015,
  3. “Sleep in Autism Spectrum Disorders,” June 2015,
  4. “Melatonin: Interactions,” accessed September 2016,
  5. “Evaluation of Sleep, Puberty and Mental Health in Children with Long-Term Melatonin Treatment for Chronic Idiopathic Childhood Sleep Onset Insomnia,” July 2011,

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