Table 7.

Efficacy and safety outcomes and subgroup and sensitivity analyses for trials of people with sleep disorders accompanying sleep restriction

Outcome	No of studies	No in melatonin group	No in placebo group	Summary measure	Point estimate (95% CI)
Efficacy
Sleep onset latency (min)	9	309	199	WMD	−1.0 (−2.3 to 0.3)
Sleep efficiency (%)	5	78	78	WMD	0.5 (−0.6 to 1.6)
Sleep quality (SD)	5	248	138	SMD	0.2 (−0.2 to 0.6)
Wakefulness after sleep onset (min)	2	44	48	WMD	−10.4 (−21.0 to 0.2)
Total sleep time (min)	7	100	100	WMD	18.2 (8.1 to 28.3)
% REM sleep	1	10	10	WMD	−3.6 (−7.3 to 0.1)
Adverse events
Headaches	9	342	218	RD	−0.01 (−0.05 to 0.02)
Dizziness	9	342	218	RD	0.00 (−0.03 to 0.03)
Nausea	10	356	235	RD	0.00 (−0.03 to 0.02)
Drowsiness	10	356	235	RD	0.00 (−0.03 to 0.03)
Subgroup and sensitivity analyses of sleep onset latency
Dosage*:
<1 mg	1	58	60	WMD	−11.8 (−23.6 to −0.0)
1-3 mg	2	77	79	WMD	−4.5 (−17.3 to 8.3)
4-5 mg	5	124	130	WMD	−1.0 (−4.0 to 2.1)
10-20 mg	1	18	18	WMD	−2.0 (−7.5 to 3.5)
Type of sleep disorder:
Jet lag	3	218	108	WMD	−4.7 (−12.6 to 3.1)
Shiftwork	5	81	81	WMD	−0.8 (−1.9 to 0.3)
Deprivation	1	10	10	WMD	−9.0 (−19.2 to 1.2)
Study design:
Parallel	4	228	118	WMD	−6.1 (−11.9 to −0.2)
Crossover	5	81	81	WMD	−0.8 (−1.9 to 0.3)
Quality:
High (Jadad score 4-5)	5	264	154	WMD	−1.2 (−4.6 to 2.3)
Moderate (Jadad score 2-3)	4	45	45	WMD	−0.9 (−2.7 to 0.8)
Allocation concealment:
Unclear	6	254	144	WMD	−1.4 (−3.8 to 1.1)
Adequate	3	55	55	WMD	−0.5 (−3.7 to 2.7)

WMD = weighted mean difference; SMD = standardised mean difference; RD= risk difference.

^*No studies with 6-9 mg dose range.