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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.