severe sleep problems in children with neurodevelopmental disorders.
Design 12 week double masked randomised placebo controlled phase
Setting 19 hospitals across England and Wales.
Participants 146 children aged 3 years to 15 years 8 months were
randomised. They had a range of neurological and developmental
disorders and a severe sleep problem that had not responded to a
standardised sleep behaviour advice booklet provided to parents four
to six weeks before randomisation. A sleep problem was defined as the
child not falling asleep within one hour of lights out or having less than
six hours’ continuous sleep.
Interventions Immediate release melatonin or matching placebo
capsules administered 45 minutes before the child’s bedtime for a period
of 12 weeks. All children started with a 0.5 mg capsule, which was
increased through 2 mg, 6 mg, and 12 mg depending on their response
Main outcome measures Total sleep time at night after 12 weeks
adjusted for baseline recorded in sleep diaries completed by the parent.
Secondary outcomes included sleep onset latency, assessments of child
behaviour, family functioning, and adverse events. Sleep was measured
with diaries and actigraphy.
Results Melatonin increased total sleep time by 22.4 minutes (95%
confidence interval 0.5 to 44.3 minutes) measured by sleep diaries
(n=110) and 13.3 (−15.5 to 42.2) measured by actigraphy (n=59).
Melatonin reduced sleep onset latency measured by sleep diaries (−37.5
minutes, −55.3 to −19.7 minutes) and actigraphy (−45.3 minutes, −68.8
to −21.9 minutes) and was most effective for children with the longest
sleep latency (P=0.009). Melatonin was associated with earlier waking
times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour
and family functioning outcomes showed some improvement and
favoured use of melatonin. Adverse events were mild and similar between
the two groups.
Conclusions Children gained little additional sleep on melatonin; though
they fell asleep significantly faster, waking times became earlier. Child
behaviour and family functioning outcomes did not significantly improve.Melatonin was tolerable over this three month period. Comparisons with
slow release melatonin preparations or melatonin analogues are required.
- sleep, melatonin