Table 2

Melatonin in sleep disorders

CitationStudy groupLevel of evidenceOutcomesKey resultsComments
MLT, melatonin.
Jan et al (1994)15 children aged 6 mth to 14 y, mean 6.8 y Most multiply disabled; 5 with epilepsy, 9 visually impaired Melatonin 2.5–5 mgDouble blind placebo controlled trial (level 1b); crossover studySleep charts Parental interviewNo adverse effects No response in 2/15 1 child—ceased effect even with 20 mg after 6 mth6 (40%) not randomised Type of sleep disturbance described
O’Callaghan et al (1999)7 children aged 2–28 y with tuberose sclerosis with epilepsy + SLD Randomised to placebo or 5 mg melatonin 20 min prior to bedtimeCrossover randomised double blind trial (level 1b)Sleep diary Total sleep time Sleep onset latency No. awakeningsMean improvement in total sleep time of 0.55 h (CI 0.088 to 1.01) No effect on fragmented sleep Sleep onset latency improved but did not reach significanceShort treatment time for any adverse effects to become apparent No effect noted on seizure frequency
Dodge and Wilson (2001)20 children with moderate to severe developmental disabilities (4/20 visual impairment); age range 1–12 years 36 recruited but only 20 completed studyRandomised double blind placebo controlled trial (level 2b)Sleep latency Duration of sleep No. awakenings Sleep log and parental questionnaireSleep latency improved in all but 2 children on MLT (p<0.05); more marked in those with greater sleep latency on baseline measure Duration of sleep improved with MLT but no different from placebo No change in number of wakeningsNo side effects reported Large drop out rate but no reported differences in diagnosis, age, epilepsy, etc in those not completing No baseline data for type or severity of sleep problems in those dropping out
Camfield et al (1996)6 children aged 3–13 y Blind with at least moderate learning disability, using 0.5–1 mg melatonin“N-of-1” double blind placebo trial (level 2b)Sleep diary Average numbers hours sleep per 24 hours Number of wakenings between 9 pm and 7 am Number of nights without wakening between 10 pm and 7 amFound MLT to be ineffective in 5/6Low dose used Timing in relation to desired sleep time may have been too long No adverse effects noted No information about blinding or randomisation
Palm et al (1997)8 aged 3–23 y (6 children aged 18 or less) All functionally blind, M/S learning disabilities 0.5–2 mg melatonin, age dependentOpen study (level 4)Sleep diaries for 6 weeks prior to treatment and several months during treatment MLT levels in 7 children“Dramatic” response in all 8 Loss of effect in 1 after 6–8 months MLT levels showed delayed peakNo side effects reported
Sheldon (1998) Published as research letter6 children, 9 months to 18 y Multiple neurological deficits and chronic sleep disorders with 5 mg at bedtimeOpen study, consecutive recruitment (level 4)Wrist actigraph Changes in sleep onset latency, nocturnal wakenings Total sleep timeMarked improvement in all 3 measures in 5/6Study stopped due to increased or new seizure type activity on melatonin in 4/6 No info on types of AE meds used