Table 7.
Melatonin Studies in Children in the United Kingdom
| Reference | N (age range, yr) | Melatonin Dosage | Duration | Summary/Comments |
|---|---|---|---|---|
| Autism | ||||
| Wright75 | 17 (3–16) | Starting dose: 2 mg; 30–40 min prior to sleep, titrations allowed, and maximum dose was 10 mg Melatonin and placebo supplied by DHP Pharma. |
3 mo with tx and crossover with 3 mo of alternative tx | Cross-over trial with melatonin and placebo in individuals with ASD who were referred by a pediatrician or specialist for sleep problems. This study assessed sleep latency, complete sleep time, and numerical quantity of awake periods throughout the night via questionnaires. Sleep latency proved to be significantly shorter with melatonin (by ~ 47 min, p = 0.004) and showed longer total sleep time (~52 min, p = 0.002); however, the difference from placebo for the number of nighttime awakenings was not significantly different. SEs were similar between groups, but the authors did note the following were reported as “never present” more often in the placebo group: daytime drowsiness (melatonin 35%, placebo 69%); reduced appetite (melatonin 35%, placebo 50%); reduced alertness (melatonin 59%, placebo 81%); and diarrhea (melatonin 71%, placebo 88%). |
| Garstang76 | 7 (4–16) | 5 mg Melatonin and placebo were produced by Penn Pharmaceutical; however, these were recalled during the time of the study for empty capsules. |
4 wk, followed by 1-wk washout period then 4 wk of alternative tx | Seven children were randomly assigned to receive placebo or melatonin. This was followed by a washout period then alternative tx. Outcomes were based on sleep charts recorded by parents/caregivers. Overall sleep time increased with placebo (8.05 hr baseline to 8.75 hr [95% CI, 8.56–8.98]) and with melatonin (9.84 hr [95% CI, 9.68–9.99]). Nighttime awakenings also decreased statistically from baseline, with placebo (0.35 baseline to 0.26 [95% CI, 0.20–0.34]) and melatonin (0.08 [95% CI, 0.04–0.12]). Study limitations: small sample size. |
| Insomnia | ||||
| Hancock77 | 21 (5–15) | 5 mg of melatonin | 2 days | Twenty-one healthy children and 7 with tuberous sclerosis. This study evaluated melatonin in generally healthy patients (n = 21) and those with tuberous sclerosis complex (n = 7) and endogenous melatonin secretion. Urine samples were collected in 24- and 48- hr periods to determine extraction of the melatonin metabolite. After the first 24 hr of tx, metabolites ranged between 11.1 and 40.1 mcg, and total course metabolites ranged from 11.1 to 40.2 mcg. Melatonin resulted in a mean improvement in total sleep time, 0.55 hr, p < 0.05. Circadian patterns of children in this study were similar to adults. |
ASD, autism spectrum disorder; IR, immediate release; SE, side effect; tx, treatment