I hear different opinions regarding taking Melatonin. Is it safe? Does it help with sleeping? What is the correct dosage? Is it for children and adults? Some people love it and cant live without it, while others don’t recommend it. How do you feel about it? Share your thoughts and comments.
Pediatricians frequently recommend melatonin for children with sleep problems, or parents might try it themselves. However, the proper use of melatonin is frequently misunderstood. Here is a guide for parents and pediatricians to decide if a child should try it, and to understand how it should be used.
Melatonin is an important tool in the treatment of sleep disorders in children, and because it is naturally derived, there is a widespread perception that it is safe. However, I have become concerned by the frequency of its use, especially in an unsupervised way.
Melatonin sales have doubled in the past ten years, increasing from $90 million in 2007 to $260 million in 2012. I worry that the widespread availability of melatonin has led to some parents using it as a shortcut to good sleep practices. A parents quote below-
OK, yes, as parents my wife and I should do a better job starting the bedtime routine earlier, turning off the TV earlier, limiting sweets, etc., etc. Well, for whatever reason, this is not our strong suit. This 1 mg light dosage of melatonin is very helpful winding our kids down and getting them ready for bed.
In one regard it is safe— unlike many other medications which cause you to fall asleep, you cannot overdose on it. However, parents need to know that melatonin is a hormone with effects throughout the body and we do not yet know what the long-term effects of melatonin use will be. Many parents in the US would be surprised to know that melatonin is only available with a prescription in the European Union or Australia.
How often are children using melatonin?
It’s hard to know for sure. A survey of 933 parents with children under age 18. One third had a history of sleep difficulties in the past year. Over half the parents reported giving melatonin to their children at one time.
What is melatonin? What does melatonin do?
Melatonin is a hormone which is naturally produced by the pineal gland in your brain. It is both a chronobiotic agent, meaning that it regulates your circadian or body clock; and a hypnotic, meaning that at higher doses it may induce sleep. Melatonin is usually used for its hypnotic effect, but it does not have this effect in everyone. Only the chronobiotic effect occurs in all individuals.
The natural rise of melatonin levels in the body 1-3 hours before sleep onset is known as the “dim light melatonin onset” (DLMO). This is the signal involved in body clock scheduling of sleep and corresponds to the end of the “wakefulness” signal produced by the circadian system. Children with insomnia may be given melatonin after their scheduled bedtime passes; what this means is that their bodies are not yet ready for sleep. The doses used clinically (0.5–10 mg or higher) greatly exceed the amount secreted in the body.
There are a few things to be aware of:
- Blue-white light exposure in the evenings shift the DLMO later. This is why bright light exposure in the evenings can worsen insomnia. I highly recommend eliminating ANY screen time for preschool through elementary school children for an hour prior to bedtime. That means no light emitting Kindles, iPads, smartphones, computers, or (God forbid) television in the bedroom For students in junior high and beyond who need to use computers to complete school work, I highly recommend lowering brightness settings and using software to reduce the blue light frequencies.
- The effect of dosing melatonin (and light therapy for that matter) are phase dependent. What that means is that the timing of giving melatonin determines both the magnitude and direction of effect. Many people do not realize that the optimal time to dose melatonin for shifting sleep period is actually a few hours before bedtime– that is to say, before the DLMO. The other facet of this is that in teenagers with severely shifted sleep schedule (delayed sleep phase syndrome) may actually have a later shift in their sleep schedule if this is not dosed correctly. Thus I would leave the timing of this to a sleep physician. Jet lag is a similar case.
- “All natural” melatonin is from cow or pig brains and should be avoided. Most preparations around now are synthetic, which is preferable.
How effective is melatonin for sleep problems in children?
The overall effects of melatonin include falling asleep more quickly and an increase in sleep time. Like all medicines used to help children fall asleep, there is fairly limited information available. It is regulated as a food supplement by the FDA.
Chronic sleep onset insomnia and Melatonin:
Problems with falling asleep are common in children, just like in adults. In children with chronic difficulty falling asleep within 30 minutes of an age-appropriate bedtime. Use of melatonin results in less difficulty with falling asleep, earlier time of sleep onset, and more sleep at night. The initial studies used pretty high doses, but later studies comparing different doses showed that dose didn’t matter, and that the lowest dose studied was as effective as the highest. This is likely due to the fact that ALL these doses were well above the amount produced naturally in the children. Timing between 6–7 PM was more effective than later doses.
Autism and Melatonin
Sleep problems are common in children with autism. Multiple types of problems occur, including prolonged time to fall asleep, less sleep during the night, and problems with nocturnal and early morning awakenings. Some children with autism have decreased levels of melatonin as well as decreased variation in melatonin secretion throughout the day. Because of this, melatonin has commonly been used in autistic children, which seems to result in less difficulty falling asleep and more sleep at night. Some studies used immediate release preparations, whereas others use long acting forms of melatonin. The majority of studies involved melatonin dosing 30–60 minutes prior to bedtime.
Interestingly, these studies also demonstrated improvement in other domains in some children– specifically, communication, social withdrawal, stereotyped behaviors, and anxiety.
As in other children, melatonin should be added to a behavioral management plan. For pediatricians, there is a great practice pathway which suggests the addition of medication only after a behavioral intervention has failed.
ADHD and Melatonin
Attention deficit hyperactivity (ADHD) is commonly associated with sleep problems, just as sleep problems can cause attentional issues. As many as 70% of children with ADHD may have sleep problems. Sleep problems include difficulty falling asleep, abnormalities in sleep architecture (e.g. the proportions of different stages of sleep), and daytime sleepiness. Trials of melatonin (in doses ranging from 3–6 mg) showed that it helped children with ADHD to fall asleep more quickly, although there was no evidence of improvement in attentional symptoms during the day. Side effects reported included problems with waking up at night and daytime sleepiness in some children.
- Side effects (known): In the short-term, melatonin seems to be quite safe. Unlike many other sleep inducing agents, “no serious safety concerns have been raised”. The most common side effects include morning drowsiness, bedwetting, headache, dizziness, nausea, and diarrhea. These effects are generally mild, and in my practice only the morning drowsiness seems to be significant. It can also interact with other medications (oral contraceptives, fluvoxamine, carbemazepine, omeprazole, and esomeprazole, to name a few).
- Side effects (theoretical): Melatonin given to children may lead to persistently elevated blood melatonin levels throughout the day. This can be associated with persistent sleepiness, but the other effects are unclear. It is important to know that melatonin has NOT been tested as closely as a pharmaceutical as the FDA regulates it as a food supplement. The studies following children who have been using melatonin long-term have relied mostly on parental reports as opposed to biochemical testing.
- Problems with preparations– poor labeling: Melatonin preparations have been shown have to variable concentrations from preparation to preparation. Moreover, the amount that a child’s body absorbs may vary. Remember that melatonin was treated as a food supplement by the FDA?This is a common preparation. . .. . .but the label is not clear that it is 0.25 mg in each dropperful. Many parents think it is 1 mg / dropperful. This means there is substantially less regulatory oversight in terms of safety and efficacy. I also find that the labelling of preparations is frequently misleading. Take the example of this liquid preparation, which many of my patients have tried. It is labeled as “1 mg” but each dropperful contains 0.25 mg.
Melatonin can be a tricky medication to dose. Effects change depending on when you give it compared to your child’s usual sleep schedule. Thus, a small dose a few hours before bedtime can have more of an effect than a large dose given at bedtime. In some situations (as with people whose sleep schedules may be flipped to a daytime sleep schedule) dosing may the opposite effect. This is a special case and should be addressed with your physician. A couple of rules of thumb.
- Timing: For shifting sleep schedules earlier 3–6 hours before current sleep onset is best. For the sleep onset effects, 30 minutes before bedtime is recommended. Remember, not every child gets sleepy with melatonin.
- Dosing: In general, I would start at a low dose (0.5–1 mg) and increase slowly. Recognize that melatonin, unlike other medications, is a hormone, and that lower doses are sometimes more effective than higher ones, especially if the benefit of it reduces with time.
- Good Sleep Hygiene is Critical: Melatonin is not a substitute for good sleep hygiene practices and should only be used in concert with a high quality bedtime, limitation on light exposure, and an appropriate sleep schedule.
What is the take home? Should my child take melatonin?
I have not met a parent who is eager to medicate their child. Such decisions are made with a lot of soul-searching, and frequently after unsuccessful attempts to address sleep problems via behavioral changes. Treatment options are limited. There are no FDA-approved insomnia medications for children except for chloral hydrate which is no longer available. Personally, I use it commonly in my practice. It is very helpful for some children and families. I appreciate Dr. Kennaway’s concerns but I have seen first hand the consequences of poor sleep on children and families. I always investigate to make sure that I am not missing other causes of insomnia (such as restless leg syndrome). My end goal is always to help a child sleep with a minimum of medications. I know that this is the goal of parents as well. Some children, especially those with autism of developmental issues, will not be able to sleep without medication. So, melatonin may be a good option for your child if:
- Behavioral changes alone have been ineffective
- Other medical causes of insomnia have been ruled out
- Your physician thinks that melatonin is a safe option for your child and is willing to follow his or her insomnia over time