Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study

Figures & data

Figure 1 Overall patient disposition. Analysis of the short-term period included eligible patients who completed three weeks of double-blind treatment with prolonged-release melatonin or placebo. Analysis of the long-term period included patients treated open-label with prolonged-release melatonin for 5 months. Analyses of actigraphic motion recordings included eligible patients who completed 3 weeks of treatment with prolonged-release melatonin and placebo and provided actigraphy data by the end of the treatment period.

Abbreviation: PRM, prolonged-release melatonin.

Table 1 Actigraphy-derived sleep parameters (mean ± standard deviation) following 3 weeks of administration of prolonged-release melatonin or placebo (crossover, n = 22)

Parameter	Placebo	PRM	Order effect P value	Treatment by order P value	Treatment effect P value
Sleep efficiency (%)	79.2 ± 9.8	83.0 ± 11.7	0.86	0.31	<0.04
Sleep latency (minutes)	18.1 ± 13.2	20.7 ± 18.0	0.66	0.90	0.36
Wake after sleep onset (minutes)	66.3 ± 38.7	38.0 ± 22.1	0.58	0.85	<0.001
Total sleep time (minutes)	366.1 ± 66.2	355.1 ± 74.5	0.84	0.09	0.41
Number of awakenings	16.5 ± 8.5	10.8 ± 5.4	0.28	0.35	<0.003

Abbreviation: PRM, prolonged-release melatonin.