Table 3.

Summary of safety outcomes from randomised controlled studies of melatonin for indications other than DSPD in children.

Study	Indication	Number of subjects (n)/age range	Melatonin dose/formulation (as single dose unless otherwise indicated)	Reported adverse effects (vs control)
Fallah et al. [90]	Migraine prophylaxis	n = 80/5–15 yrs	0.3 mg/kg/day for 3 months	Daytime somnolence in 3 children
Myers et al. [91]	Dravet syndrome	n = 13/2–50 yrs	6 mg/day for 2 weeks	No adverse effects
Ardakani et al. [92]	Atopic dermatitis	n = 70/6–12 yrs	6 mg/day for 6 weeks	No adverse effects
Impellizzeri et al. [162]	Surgical premedication	n = 80/9–11 yrs	0.5 mg/kg to 20 mg max	No adverse effects
Mostafavi et al. [93]	Weight gain in bipolar disorder	n = 48/11–17 yrs	3 mg/day for 12 weeks	No adverse effects
Gitto et al. [94]	Surgical premedication	n = 92/5–14 yrs	0.5 mg/kg/day	No adverse effects
Marseglia et al. [100]	Blood withdrawal anxiety	n = 60/1–14 yrs	0.5 mg/kg/day to 5 mg max	No adverse effects
Fallah et al. [102]	EEG premedication	n = 60/1–8 yrs	0.3 mg/kg/day	No adverse effects
Almenrader et al. [98]	Anaesthesia induction	n = 87/12–71 yrs	0.3 mg/kg/day	No adverse effects
Gitto et al. [99]	Neonatal analgesia	n = 60/5–14 yrs	0.5 mg/kg/day	No adverse effects
Sander et al. [103]	EEG premedication	n = 50/1–18 yrs	3 mg < 15 kg 6 mg > 15 kg	No adverse effects
Ozcengiz et al. [101]	Post-operative anxiety	n = 100/3–9 yrs	0.1 mg/kg/day	No adverse effects
Kain et al. [95]	Surgical premedication	148/2–8 yrs	0.05–0.4 mg/kg/day	No adverse effects
Isik et al. [96]	Surgical premedication	n = 60/508 yrs	3 mg/day	No adverse effects
Sury [105]	Sedation for magnetic resonance imaging	n = 98/0.3–4 yrs	3–6 mg/day	No adverse effects
Samarkandi et al. [97]	Surgical premedication	n = 105/2–5 yrs	0.1–0.5 mg/kg/day	No adverse effects
Wassmer et al. [104]	EEG sleep study	n = 163/1–16 yrs	2–10 mg/day	No adverse effects