Table 3.

Melatonin supplementation in ASD patients.

References	Study Design	Number of Patients	Age	Diagnosis	Melatonin Dosage	Time of Melatonin Supplementation (before Bedtime)	Duration of Melatonin Supplementation
Gupta R, et al. 2005 [92]	Retrospective study	9	2–11 years	ASD	2.5–5 mg	45 min
Giannotti F, et al. 2006 [93]	Open label	20	2.6–9.1	ASD	3 mg (1 mg FR and 2 mg CR)–6mg	30–40 min	2 years
Garstrang J, et al. 2006 [94]	DB-RCT	7	4–16	ASD ADHD	5 mg		4 weeks
Andersen IM, et al. 2008 [95]	Retrospective study	107	2−18	ASD	0.75–6 mg	30–60 min	1.8 ± 1.4 years
Wasdell MB, et al. 2008 [96]	DB-RCT	50	2.05−17.81	Severe intellectual loss Cerebral palsy Epilepsy Visual impairment Lack of mobility ASD	5 mg CR	20–30 min	10 days
Wirojanan J, et al. 2009 [97]	DB-RCT	12	2–15.25	ASD Fragile X syndrome	3 mg	30 min	2 weeks
Wright B, et al. 2011 [98]	DB-RCT	16	4–16	ASD	2–10 mg	30–40 min	3 months
Cortesi F, et al. 2012 [90]	DB-RCT	74	4–10	ASD	3 mg CR	21:00	12 weeks
Gringras P, et al. 2012 [99]	DB-RCT	51	3.7–15	DD alone DD and epilepsy DD and ASD DD, ASD, epilepsy DD and “other”	0.5–12 mg	45 min	12 weeks
Malow B, et al.2012 [59]	Open label	24	3−10	ASD	1–6 mg	30 min	14 weeks
Goldman S, et al. 2014 [48]	Open label	9	3−8	ASD	1–3 mg	30 min	3–6 weeks
Gringras P, et al. 2017 [100]	DB-RCT	58	2−17	ASD SMS	2–5 mg of PedPRM		13 weeks
Maras A, et al. 2018 [101]	DB-RCT	51	2−17.5	ASD Neurogenetic disorders	2–10 mg of PedPRM	30−60 min	52 weeks
Schroder CM, et al. 2019 [102]	DB-RCT	58	2−17.5	ASD SMS	2–5 mg of PedPRM	30−60 min	13 weeks
Malow BA, et al. 2020 [103]	DB-RCT	74	2−17.5	ASD SMS	2–10 mg of PedPRM	30−60 min	104 weeks

DB-RCT—double blind, randomized control trial, CR—controlled-release, FR—fast release, DD—developmental delay, PedPRM—pediatric-appropriate 3 mm diameter prolonged release melatonin minitablet, SMS—Smith–Magenis syndrome.