Comparison 1. Melatonin versus placebo: efficacy.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Total nocturnal sleep time (minutes)	2	184	Mean Difference (IV, Fixed, 95% CI)	10.68 [‐16.22, 37.59]
1.1.1 Melatonin immediate‐release	2	106	Mean Difference (IV, Fixed, 95% CI)	‐1.34 [‐37.13, 34.45]
1.1.2 Melatonin slow‐release	1	78	Mean Difference (IV, Fixed, 95% CI)	26.30 [‐14.49, 67.09]
1.2 Sleep efficiency	1	151	Mean Difference (IV, Fixed, 95% CI)	‐0.01 [‐0.04, 0.03]
1.2.1 Melatonin immediate‐release	1	73	Mean Difference (IV, Fixed, 95% CI)	‐0.01 [‐0.06, 0.04]
1.2.2 Melatonin slow‐release	1	78	Mean Difference (IV, Fixed, 95% CI)	0.00 [‐0.05, 0.05]
1.3 Nocturnal time awake (minutes)	1	151	Mean Difference (IV, Fixed, 95% CI)	9.08 [‐7.51, 25.66]
1.3.1 Melatonin immediate‐release	1	73	Mean Difference (IV, Fixed, 95% CI)	10.80 [‐11.90, 33.50]
1.3.2 Melatonin slow‐release	1	78	Mean Difference (IV, Fixed, 95% CI)	7.10 [‐17.20, 31.40]
1.4 Number of nocturnal awakenings	1	33	Mean Difference (IV, Fixed, 95% CI)	6.00 [‐2.65, 14.65]
1.5 Mean duration of nocturnal sleep bouts (minutes)	1	33	Mean Difference (IV, Fixed, 95% CI)	‐2.00 [‐8.27, 4.27]
1.6 Ratio of daytime sleep to night‐time sleep	2	184	Mean Difference (IV, Fixed, 95% CI)	‐0.13 [‐0.29, 0.03]
1.6.1 Melatonin immediate‐release	2	106	Mean Difference (IV, Fixed, 95% CI)	‐0.12 [‐0.28, 0.05]
1.6.2 Melatonin slow‐release	1	78	Mean Difference (IV, Fixed, 95% CI)	‐0.25 [‐0.78, 0.28]
1.7 Carer‐rated sleep quality, change from baseline	3	195	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.02 [‐0.32, 0.28]
1.7.1 Melatonin immediate‐release	2	104	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.25 [‐0.65, 0.16]
1.7.2 Melatonin slow‐release	2	91	Std. Mean Difference (IV, Fixed, 95% CI)	0.25 [‐0.19, 0.69]
1.8 MMSE, change from baseline	2	162	Mean Difference (IV, Fixed, 95% CI)	0.09 [‐0.85, 1.03]
1.8.1 Melatonin immediate‐release	1	73	Mean Difference (IV, Fixed, 95% CI)	‐0.54 [‐1.99, 0.91]
1.8.2 Melatonin slow‐release	2	89	Mean Difference (IV, Fixed, 95% CI)	0.54 [‐0.69, 1.76]
1.9 ADAS‐cog, change from baseline	2	162	Mean Difference (IV, Fixed, 95% CI)	‐1.03 [‐2.70, 0.65]
1.9.1 Melatonin immediate‐release	1	73	Mean Difference (IV, Fixed, 95% CI)	‐0.43 [‐2.95, 2.09]
1.9.2 Melatonin slow‐release	2	89	Mean Difference (IV, Fixed, 95% CI)	‐1.50 [‐3.74, 0.74]
1.10 ADL, change from baseline	3	193	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐0.34, 0.26]
1.10.1 Melatonin immediate‐release	2	104	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.05 [‐0.45, 0.36]
1.10.2 Melatonin slow‐release	2	89	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐0.48, 0.41]
1.11 Carer burden	1	31	Mean Difference (IV, Fixed, 95% CI)	‐6.20 [‐19.81, 7.41]