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Table 4 Sleep diary parameters in the low excretors.

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 effects
   Change from baseline Mean (SD) Short term Long term *
   Visit 3 Visit 7 Estimate (95% CI) P -value Estimate (95% CI) P -value
N MAX PRM 86 99   
  Placebo 86 31   
Sleep latency PRM -9.0 (50.5) -23.6 (42.1) -0.6 (-14.0, 12.7) -6.7 (-16.4, 3.0)
(min) Placebo -9.0 (48.7) -19.4 (79.5) P = 0.924 P = 0.174
Sleep PRM -0.27 (0.77) -0.31 (1.08) -0.16 (-0.39, 0.08) -0.04 (-0.24, 0.16)
maintenance Placebo -0.12 (1.04) -0.34 (0.71) P = 0.185 P = 0.677
Total sleep PRM 0.34 (0.88) 0.70 (1.00) 9.1 (-6.1, 24.4) 13.1 (1.0, 25.2)
time (h) Placebo 0.20 (0.91) 0.47 (1.18) P = 0.236 P = 0.035
Sleep onset PRM -0.15 (0.89) -0.46 (0.79) -0.08 (-0.33, 0.17) -0.16 (-0.34, 0.03)
(h) Placebo -0.05 (0.80) -0.24 (1.11) P = 0.530 P = 0.096
Sleep offset PRM 0.09 (0.79) 0.08 (0.84) 0.04 (-0.18, 0.25) 0.07 (-0.09, 0.22)
(h) Placebo 0.10 (0.75) 0.20 (1.00) P = 0.744 P = 0.392
Refreshed on PRM -0.09 (0.46) -0.23 (0.43) -0.01 (-0.13, 0.11) -0.03 (-0.12, 0.06)
waking Placebo -0.09 (0.40) -0.29 (0.47) P = 0.830 P = 0.540
Morning PRM -0.14 (0.67) -0.42 (0.65) 0.01 (-0.18, 0.19) -0.06 (-0.19, 0.08)
alertness Placebo -0.19 (0.63) -0.35 (0.73) P = 0.936 P = 0.426
Sleep quality PRM -0.20 (0.67) -0.43 (0.70) -0.04 (-0.24, 0.16) -0.08 (-0.23, 0.06)
  Placebo -0.16 (0.70) -0.34 (0.60) P = 0.688 P = 0.266
  1. *The global treatment effect is estimated using a mixed-effect model for repeated measures and takes into account the treatment effect difference over the 26-weeks (at Visits 3, 4, 5, 6 and 7) sleep latency (diary data) are repeated for completeness
  2. C, confidence interval; SD, standard deviation; PRM, prolonged release melatonin.