Table 4.

Efficacy and safety outcomes and subgroup and sensitivity analyses for trials of melatonin in people with secondary sleep disorders

Outcome	No of studies	Melatonin group	Placebo group	Summary measure	Point estimate (95% CI)
Efficacy
Sleep onset latency (min)	6	82	81	WMD	−13.2 (−27.3 to 0.9)
Sleep efficiency (%)	6	187	129	WMD	1.9 (0.5 to 3.3)
Wakefulness after sleep onset (min)	3	137	80	WMD	−6.3 (−16.6 to 3.9)
Total sleep time (min)	9	220	162	WMD	15.6 (7.2 to 24.0)
REM sleep (%)	1	14	14	WMD	−1.5 (−4.4 to 1.4)
Adverse events
Headaches	7	127	126	RD	0.02 (−0.03 to 0.07)
Dizziness	7	127	126	RD	0 (−0.03 to 0.03)
Nausea	7	127	126	RD	0 (−0.03 to 0.03)
Drowsiness	7	127	126	RD	0 (−0.03 to 0.03)
Subgroup and sensitivity analyses of sleep onset latency
Age (years)*:
Children (0-18)	3	33	33	WMD	−18.1 (−29.4 to −6.8)
Adults (19-65)	3	49	48	WMD	−6.6 (−24.6 to 11.4)
Co-morbidity*:
Rett syndrome	1	9	9	WMD	−12.9 (−27.6 to 1.8)
Tuberous sclerosis	1	7	7	WMD	−23.4 (−45.2 to −1.6)
Developmental disabilities	1	17	17	WMD	−30.0 (−60.2 to 0.2)
Depression	1	16	15	WMD	−13.5 (−32.5 to 5.5)
Schizophrenia	2	33	33	WMD	−4.6 (−29.8 to 20.6)
Dosage (mg):
1-3	2	33	33	WMD	−4.6 (−29.8 to 20.6)
4-5	1	7	7	WMD	−23.4 (−45.2 to −1.6)
6-10	1	16	15	WMD	−13.5 (−32.5 to 5.5)
Duration (weeks)*:
1-2	2	24	24	WMD	−25.7 (−43.3 to −8.0)
3-4	2	33	33	WMD	−4.6 (−29.8 to 20.6)
>4	2	25	24	WMD	−13.1 (−24.8 to −1.5)
Measurement method*:
Polysomnography	1	14	14	WMD	5.8 (2.5 to 9.1)
Actigraphy	3	44	43	WMD	−14.5 (−25.0 to −4.1)
Questionnaire	2	24	24	WMD	−25.7 (−43.3 to −8.0)
Study design:
Parallel	1	16	15	WMD	−13.5 (−32.5 to 5.5)
Crossover	5	66	66	WMD	−13.5 (−29.7 to 2.8)
Allocation concealment*:
Unclear	5	68	67	WMD	−17.4 (−26.4 to −8.4)
Adequate	1	14	14	WMD	5.8 (2.5 to 9.1)

WMD = weighted mean difference; RD= risk difference

^*P<0.001, Deeks χ² test.