03.01.11
Nutraceutical: Prolonged Release Melatonin (PRM)
Indication: Insomnia
Source: Curr Med Res Opin, January 2011;27(1):87-98.
Research: A total of 930 males and females aged 18-80 years with primary insomnia who reported mean nightly sleep latency (SL) >20 minutes were enrolled; 791 entered the active phase of the study. The study comprised a 2-week, single-blind placebo run-in period followed by 3 weeks of double-blind treatment with PRM or placebo, one tablet per day at 2 hours before bedtime. PRM patients continued whereas placebo completers were re-randomized 1:1 to PRM or placebo for 26 weeks followed by 2-weeks run-out on placebo.
Results: In all, 746 patients completed the 3-week treatment and 555 (421 PRM, 134 placebo) completed the 6-month period. The principal reason for drop-out was patient decision. At 3 weeks, significant differences in SL (diary, primary variable) in favor of PRM vs. placebo treatment were found for the 55-80-year group but not the 18-80-year cut-off, which included younger patients. Other variables improved significantly with PRM in the 18-80-year population, more so than in the 55-80-year age group. Researchers believe the results demonstrate short- and long-term efficacy of PRM in insomnia patients aged 18-80 years, particularly those aged 55 and older. PRM was well-tolerated over the entire 6-month period with no rebound or withdrawal symptoms following discontinuation.
Indication: Insomnia
Source: Curr Med Res Opin, January 2011;27(1):87-98.
Research: A total of 930 males and females aged 18-80 years with primary insomnia who reported mean nightly sleep latency (SL) >20 minutes were enrolled; 791 entered the active phase of the study. The study comprised a 2-week, single-blind placebo run-in period followed by 3 weeks of double-blind treatment with PRM or placebo, one tablet per day at 2 hours before bedtime. PRM patients continued whereas placebo completers were re-randomized 1:1 to PRM or placebo for 26 weeks followed by 2-weeks run-out on placebo.
Results: In all, 746 patients completed the 3-week treatment and 555 (421 PRM, 134 placebo) completed the 6-month period. The principal reason for drop-out was patient decision. At 3 weeks, significant differences in SL (diary, primary variable) in favor of PRM vs. placebo treatment were found for the 55-80-year group but not the 18-80-year cut-off, which included younger patients. Other variables improved significantly with PRM in the 18-80-year population, more so than in the 55-80-year age group. Researchers believe the results demonstrate short- and long-term efficacy of PRM in insomnia patients aged 18-80 years, particularly those aged 55 and older. PRM was well-tolerated over the entire 6-month period with no rebound or withdrawal symptoms following discontinuation.
