DTB | Melatonin for sleep problems in children with neurodevelopmental disorders

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Melatonin for sleep problems in children

with neurodevelopmental disorders
Children with neurodevelopmental disorders are at risk of sleep problems, typically difficulty getting to sleep, sleep/wake
rhythm disturbances and reduced duration of sleep (insomnia).1,2 This may be associated with abnormally timed or
inadequate secretion of melatonin, a naturally-occurring hormone involved in coordinating the body’s sleep-wake cycle.1,3
Previously, we reviewed the use of a melatonin product licensed for primary insomnia in adults aged over 55 years.4 Here
we review off-label and unlicensed use of melatonin in children with attention-deficit hyperactivity disorder (ADHD) or
autism spectrum disorder or related neurodevelopmental disorders.

Background Treatment of sleep disorders

During the first month of life, the sleep-wake cycle starts to adapt to night
and day, and by one year, most children sleep through the night. 5 Children
aged 6–12 years typically fall asleep within 20 minutes of going to bed
(sleep onset latency [SOL]) and sleep for 8–9.5 hours (total sleep duration
[TSD]) with few night-time awakenings (high sleep efficiency [minutes
sleeping in bed/total minutes in bed]).6 Sleep disorders affect 20–30% of
children aged 1–5 years, and often persist as the child gets older.1,7 They
can impair daytime functioning and be a problem for the child as well as
their family.8
Assessment of sleep disorders
Sleep disorders may be caused by many factors and to manage them
effectively requires careful clinical assessment.9
The history should identify:
• the nature of the problem (e.g. delay in falling asleep, frequent waking,
unusual behaviour, daytime sleepiness);
• usual day and night sleep patterns, and any change to those patterns;
• whether bedtime is regular;
• what the sleep environment is like (e.g. background noise; use of a
blackout blind; TV/computer in the bedroom; shared room);
• comorbidities;
• levels of activity and exercise during the day;
• effects of any medication;
• other factors thought to enhance or disturb sleep (e.g. emotional
relationships, school problems); and
• the impact of sleep and behavioural problems on family members.10
A sleep diary should be kept for at least 2 weeks.11
Concomitant epilepsy, gastro-oesophageal reflux, iron deficiency
and primary sleep disorders (e.g. obstructive sleep apnoea, periodic
limb movements) should be identified and referral considered
where necessary.10,11
Specialist investigations may include actigraphy (use of a sensor that
measures movement as a surrogate for wakefulness) and polysomnography
(sleep study that records brain electrical activity; eye, jaw and leg muscle
movement; airflow; chest and abdominal excursions; oxygen saturation and
ECG).9,12 Assessment of melatonin release in response to reduced lighting
(dim light melatonin onset) is rarely performed.9,12
A sleep plan should be developed with parents and reviewed regularly,
using a sleep diary.10 First-line interventions for children with insomnia
include behavioural therapy (individualised because it is strongly influenced
by the type of neurological deficit and the child’s environment), stimulus
control (i.e. bedroom used only for sleep), ‘extinction’ (parental scheduled
checks, removal of parental attention) and bedtime ‘fading’ (gradually
moving bedtime earlier by 15-minute intervals).1,8,13
Some problems may respond to adjustment of dose of any stimulant
medication being taken (e.g. reducing the total dose; changing the regimen
or formulation so less medication is administered later in the day; adding a
third dose of stimulant in the evening if sleep-onset delay is due to a
rebound effect) or switching to an agent associated with fewer sleep
difficulties (e.g. atomoxetine).1,12
Drugs to treat sleep problems should be used conservatively, with realistic
treatment expectations, using the lowest effective dose for short courses,
with appropriate monitoring (e.g. for sleep, cognition, behaviour, academic
performance, quality of life, adverse events), and regular breaks in therapy
to assess continued need.14
Sedatives are typically ineffective in children with neurological disorders.6
Classical hypnotics may be addictive3 and may be associated with serious
unwanted effects including respiratory depression, daytime somnolence
and tachyphylaxis.15
A clinically significant improvement in sleep is defined as a reduction in SOL
to less than 30 minutes, or an increase in TSD of more than an hour.16
About melatonin
Endogenous melatonin (N-acetyl-5-methoxytryptamine) is synthesised and
secreted by the pineal gland in the brain from soon after the onset of
darkness, with secretion peaking at 2–4a.m. and falling during the second
half of the night.4 It helps control circadian rhythms and sleep regulation,
primarily by acting at MT1 and MT2 receptor subtypes in the suprachiasmatic
nucleus of the anterior hypothalamus.4
There is very little endogenous melatonin in infants under 3 months old;
circadian secretion develops in older children, with peak nocturnal levels
highest in the first 1–3 years of life, then there is a gradual decline in
production, reaching a low level in old age.17,18
In the UK, melatonin is not licensed for use in children. A prolonged-release
formulation of melatonin is licensed for short-term treatment for primary
insomnia in people aged 55 years or over.19 Unlicensed preparations of
immediate-release melatonin are often prescribed for children who have

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difficulty sleeping.16 Although melatonin is thought to have few unwanted
effects, there are concerns about its relationship to epileptic seizures, and
delays in sexual maturation (reported in animal studies; effects on the
onset of puberty in children are uncertain).14,18
ADHD
Up to 70% of children with ADHD experience sleep problems, and around a
third of children who are not taking any medication for their ADHD have
chronic sleep onset insomnia (average sleep latency >30 minutes).1,9
Poor night-time routines (e.g. use of electronic gadgets before bedtime),
the child’s difficulty slowing thoughts and settling for sleep, difficulty for
parents setting limits and managing behaviour, psychiatric and medical
comorbidities and unwanted effects of stimulant medication may contribute
to sleep problems in children with ADHD.12,20
Other sleep problems may include resistance in going to bed, night
awakenings, difficulty with morning awakenings, daytime sleepiness and
restless legs syndrome.9,20 Sleep deprivation potentially worsens ADHD
symptoms and intensifies disruptive behaviours.20 Sleep onset insomnia in
children with ADHD may be associated with a delay in dim light melatonin
onset and abnormal melatonin genetic pathways.9
Evidence for melatonin treatment
Systematic reviews8,12,14,20 identified two double-blind randomised placebo-
controlled studies of melatonin for children with ADHD-related sleep
disorders,21,22 and a follow-up study23 of the patients from one of these trials.21
The studies were not combined in meta-analysis in any of the reviews.
The first crossover study involved 19 children with ADHD (aged 6–14 years,
mean 10 years) and who still had a mean sleep onset latency (SOL) >60
minutes (or SOL >60 minutes on ≥30% of nights) after a sleep hygiene
intervention (consistent bedtime, discontinuation of caffeine and naps). 22
The children received immediate-release melatonin (5mg) or placebo,
20 minutes before bedtime for 10 days, followed by 5 days washout, then
the alternate treatment and a further washout. 22 Mean SOL before
treatment was 92 minutes assessed by somnolog (carer-completed record
of when the child was asleep/awake) and 98 minutes by actigraph; this
reduced to 69 and 73 minutes, respectively, after the sleep hygiene
intervention. Melatonin resulted in a statistically significant improvement
of 16 minutes in somnolog SOL compared with placebo (SOL 46 [standard
deviation, SD 26] minutes with melatonin and 62 [SD 27] minutes with
placebo, p<0.01); actigraph SOL (better than placebo by 16 minutes,
p<0.01); and somnolog TSD (better than placebo by 15 minutes, p<0.01).
The difference in actigraph TSD was not statistically significant; maximum
TSD was artificially limited by the sleep hygiene intervention that
specified bedtime and rising time. ‘Responder to treatment’ was defined
as a clinician rating of ‘much improved’ or ‘very much improved’ using the
Clinical Global Impression of Improvement scale, taking all aspects of the
child’s well-being into account, including sleep, and this was achieved by
17/19 of the children who continued open label melatonin for 3 months,
with a mean SOL at the end of this time of 31 minutes and improvement
of TSD by 23 minutes (p<0.01). 22 The only adverse events related to the
study were rashes caused by the actigraph wristband in two patients.
The second study involved 105 children with ADHD (aged 6–12 years, mean
9.2 years) with sleep onset insomnia who received melatonin (3mg if
body weight <40kg; 6mg if body weight >40kg) or placebo, at 7pm for
4 weeks. 21 Children were allowed to go to bed when tired. Compared with
baseline, sleep onset improved with melatonin (–27 [±48] minutes) and
worsened with placebo (+11 [±37] minutes; p<0.0001 between groups).
Total time asleep increased by 20 [±62] minutes with melatonin from a
baseline of 519 [±48] minutes compared with a reduction of 14 [±51]
minutes with placebo from a baseline of 534 [±48] minutes (p=0.01).
There were no discontinuations or withdrawals due to adverse events,
and no adverse events (e.g. headache, hyperactivity, dizziness, abdominal
pain) required treatment.8,21
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At the end of this trial, all participants were offered melatonin as part of
their regular care, with a break of treatment for 1 week each year to
evaluate whether melatonin was still necessary.23 At a mean follow-up
of 3.7 years, 94/105 parents returned questionnaires; 61 children still used
melatonin daily; 11 used it occasionally (ranging from 2–3 times a week to a
few times a year); and 22 had discontinued melatonin completely.23 Around
88% of parents agreed that melatonin was effective for their child’s sleep
onset problems; 71% that it improved their child’s daytime behaviour and
61% that it improved their child’s mood. When treatment was temporarily
discontinued, 60 children had delayed sleep onset; 20 had delayed waking
time and 19 had changes in daytime behaviour.23
Autism spectrum disorder and related
neurodevelopmental disorder
Sleep problems such as reduced total sleep duration (TSD), longer SOL,
nocturnal awakenings (which may last 2–3 hours) and early morning
awakenings are common in children with autism spectrum disorder, with
prevalences reported between 30–86%.9,11,24 Children with autism spectrum
disorder often have abnormal melatonin levels (especially at night) and an
abnormal circadian rhythm, and some have genetic abnormalities in
melatonin production or melatonin receptor function.9,24 These
abnormalities correlate with impaired communication and play, abnormal
EEG patterns and hyperactivity.24 Children with autism spectrum disorder are
often less responsive to behavioural therapy.17
Evidence for melatonin treatment
A systematic review24 identified five randomised, double-blind crossover
studies involving people with autism spectrum disorder.6,13,25–27 Meta-
analysis found that TSD was 73 minutes longer with melatonin versus
baseline, and 44 minutes longer than with placebo (no p values reported).24
Similarly, SOL was 66 minutes shorter with melatonin than at baseline and
39 minutes shorter than with placebo (no p values reported).24
Another systematic review17 identified a further study28 that included
146 children aged 3–16 years with neurodevelopmental disorders, of whom
some had autism spectrum disorder. They received placebo or melatonin
(0.5–12mg), 45 minutes before bedtime for 12 weeks. Compared with
placebo, melatonin produced a statistically significant increase in TSD
(22 minutes, 95% CI 0.5 to 44 minutes, p=0.04) assessed by sleep diaries
but not in TSD measured by actigraphy. Melatonin reduced SOL measured
by sleep diaries (−38 minutes, 95% CI −55 to −20, p<0.001) and actigraphy
(−45 minutes, 95% CI −69 to −22, p<0.001). Seven serious adverse events
were reported, of which two (one in the placebo group and one in the
melatonin group) were considered related to the study drug in a blinded
assessment.16,28
Another study involved 160 children (aged 4–10 years) with autism
spectrum disorder who had sleep onset insomnia and impaired sleep
maintenance.29 Participants were randomised to one of four groups:
a combination of controlled release (CR) melatonin (3mg at 9pm) and
cognitive–behavioural therapy (CBT); CR melatonin (3mg at 9pm); four
sessions of CBT; or placebo drug treatment for 12 weeks.29 Children in all
three active groups showed greater improvement than those on placebo
(standard sleep criterion of SOL ≤30 minutes or reduction of SOL by 50%:
85% with the combination, 39% with melatonin, 10% with CBT and 0%
with placebo; sleep efficiency 85% or more: 63% with the combination,
46% with melatonin, 10% with CBT and 0% with placebo).29
What guidelines say
In 2013, the National Institute for Health and Care Excellence (NICE)
published an evidence review of the unlicensed or off-label use of
melatonin.1 It concluded that limited evidence from the two small
studies21,22 and the follow-up study23 described above, suggests that
unlicensed melatonin products (3–6mg daily, taken just before bedtime
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for 10 days–4 weeks) may improve sleep onset in children with sleep
onset insomnia and ADHD by around 20 minutes, and improve TSD by
15–20 minutes. However, there are limitations to these small studies,
and longer term efficacy is unclear.1
NICE guidelines for autism recommend not using a pharmacological
intervention to improve sleep unless problems persist despite following a
sleep plan, and if such problems are having a negative impact on the child
and their family.10
If a pharmacological intervention is used to aid sleep it should:
• only be used following consultation with a specialist paediatrician or
psychiatrist with expertise in the management of autism or paediatric
sleep medicine;
• be used in conjunction with non-pharmacological interventions; and
• be regularly reviewed to evaluate the ongoing need for a
pharmacological intervention and to ensure that the benefits continue
to outweigh the adverse effects and risks.10
A consensus conference in 2014 on the current role of melatonin in
paediatric neurology (including use in children with ADHD and autism
spectrum disorder) suggested that when used as a sleep inducer, it
should be given 30 minutes before bedtime.9 Treatment duration should
be tailored to the patient but should generally not be less than 1 month.9
Treatment should be stopped once a year for a week in summer.9 If
melatonin becomes ineffective, the timing of administration should
be checked as it may be being given too late; metabolism may have
become slowed (e.g. by drugs); any neuropsychiatric comorbidity
should be identified and treated; and the dose of melatonin may need
to be reduced.9
Practical issues
In the UK, melatonin is classified as a prescription only medicine.
Unlicensed melatonin products are available from special-order
manufacturers or specialist importing companies.i As there is no standard
formulation, there may be variability in the clinical effect of these
unlicensed formulations.1 Melatonin products available in other countries as
dietary supplements are not regulated in the same way as pharmaceutical
products.17 Prescribers should ensure that only products that are
manufactured according to pharmaceutical good manufacturing practices
and have undergone rigorous quality testing by an independent regulatory
organisation are used. When an unlicensed product is prescribed the
manufacturer should be specified because of variability in clinical effect of
unlicensed formulations. 30
The British National Formulary for Children states that melatonin is not
licensed for use in children, but suggests a dose for a child 1 month–18
years of 2–3mg daily before bedtime initially, increased if necessary after
1–2 weeks to 4–6mg daily before bedtime, with a maximum of 10mg daily. 30
Little is known about its long-term effects in children. Treatment
should be initiated by a specialist but may be continued under a
shared-care arrangement.
Melatonin is metabolised by the CYP1A2 enzyme, so drugs affecting the CYP
enzymes may affect the metabolism of melatonin, while melatonin may
also inhibit CYP1A2 and CYP3A, leading to increased concentrations of other
medications metabolised by these enzymes.9,17 As melatonin may decrease
blood pressure or serum glucose, patients receiving medication that affects
blood pressure or glucose should be monitored.17 Prescribers should monitor
for any worsening of seizure control, or of mood in people with depression,
and caution is advised in people with asthma due to the potential
pro-inflammatory properties of melatonin.18

Adverse effects of melatonin

The most commonly reported adverse effects of melatonin include
morning drowsiness, enuresis, headache, dizziness, diarrhoea, rash and
hypothermia.9 Slight transient headache and gastrointestinal symptoms
are mainly reported in the first few days of treatment.9 Long-term adverse
effects are unknown.
Costs
The cost of a 30 tablet pack of 2mg CR melatonin (Circadin) is £15.39. Costs
for unlicensed liquid oral preparations listed in the Drug Tariff range from
£78 to £255 for a dose of 5mg per day for 30 days. Unlicensed melatonin
capsules vary considerably in price.

Conclusion
Sleep problems are common in children with neurodevelopmental disorders and may be associated with abnormalities in the metabolism of
melatonin, a hormone involved in the sleep-wake cycle. The child’s history should be carefully assessed as there may be features amenable to
management (e.g. adjusting concomitant medication). Sleep hygiene and behavioural interventions are also sometimes helpful and should be tried
before drug treatment is introduced. Based on a limited number of small, short-term clinical trials, melatonin has been shown to reduce the delay
before sleep onset and increase the total duration of sleep. However, the absolute size of such changes is quite small. Little is known about
melatonin's long-term effects in children.
Melatonin is available as a modified-release tablet licensed for short-term use in adults aged over 55 years and also as unlicensed formulations.
Off-label use of the licensed product provides reassurance about manufacturing quality. If melatonin is to be used, the prescriber should provide
sufficient information to allow parents and children to make an informed decision on the unlicensed use of melatonin. Prescribing should be initiated
by a specialist and the arrangement for providing further supplies of melatonin clearly documented. An agreed treatment plan should be in place to
ensure that children are followed up regularly to assess response to therapy, unwanted effects and the need for long-term treatment.

[R=randomised controlled trial; M=meta-analysis]
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DOI: 10.1136/dtb.2015.10.0358

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Melatonin for sleep problems in children with

neurodevelopmental disorders

DTB 2015 53: 117-120

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