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Table 3 Effects of 3 weeks treatment with prolonged release melatonin (PRM) and placebo on sleep diary-recorded sleep latency in the low excretors and the elderly patients.

From: Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety

 

Treatment

Treatment effect difference PRM - placebo; (95% confidence interval)

Pvalue*

effect PRM versus placebo

 

PRM

Placebo

  

Low excretor population

    

N

86

86

  

Baseline: mean (SD)

74.1 (54.9)

75.5 (58.5)

  

Treatment: mean (SD)

65.1 (59.9)

66.5 (51.6)

  

Change from baseline: mean (SD)

-9.0 (50.5)

-9.0 (48.7)

-0.6 (-14.0, 12.7)

0.924

65-80 year population

    

N

137

144

  

Baseline: mean (SD)

76.7 (63.7)

72.5 (51.4)

  

Treatment: mean (SD)

57.6 (51.8)

70.9 (54.0)

  

Change from baseline: mean (SD)

-19.1 (47.3)

-1.7 (47.8)

-15.6 (-25.3, -6.0),

0.002

  1. *Linear regression model with terms for treatment (PRM versus placebo), baseline sleep latency and age group (≥65 or <65 - only for the low excretors).
  2. PRM, prolonged release melatonin; SD, standard deviation.