Prolonged release melatonin in the treatment of primary insomnia: evaluation of the age cut-off for short- and long-term response

Abstract

The results demonstrate short- and long-term efficacy of PRM in insomnia patients aged 18-80 years, particularly those aged 55 and over. PRM was well-tolerated over the entire 6-month period with no rebound or withdrawal symptoms following discontinuation. Study Registry No: ClinicalTrials.gov ID: NCT00397189.

The role of the melatoninergic system in epilepsy and comorbid psychiatric disorders

“…Indeed, long-term treatment with a combination of melatonin and low doses of the 5-HT1A receptor agonist buspirone exerted a beneficial activity and few side effects in patients with acute MDD (Fava et al, 2012). It seems that the beneficial effect of melatonin treatment as an adjuvant to other antidepressants is associated with its ability to synchronize disturbed circadian rhythms in patients with depression and a deficit of melatonin secretion (Haimov et al, 1995;Garfinkel et al, 1995;Jan et al, 2001;Mittal et al, 2010;Wade et al, 2010).…”

Evidence for the efficacy of melatonin in the treatment of primary adult sleep disorders

“…Quantitative analysis of the five eligible RCTs [44,[46][47][48][49] showed an overall significant reduction in the time to fall asleep between the effect on sleep onset latency for melatonin in patients with primary insomnia compared with placebo (Total mean difference = -5.05 minutes, 95% CI: -8.51, -1.59). The overall estimated score of melatonin treatment was significant (Z=2.86, P=0.004) (Fig.2).…”

“…In all five studies for primary insomnia [44][45][46][47][48][49] there were large sample sizes, which increased reliability of results (n=40-791). The studies used a thorough prescreening assessment which was deployed to reduce confounding factors and use of medications such as benzodiazepines were stopped beforehand.…”

“…[84] Wade et al [48] preformed a trial over six months of daily melatonin use and demonstrated no adverse effects or rebound withdrawal symptoms. Two studies [62,85] that arise from sleep restriction (e.g., jet lag, shift-work), [4] but the results of their review may be partly attributable to trial limitations similar to those discussed in the current paper.…”

“…Participants unsuitable (n= 5) [26][27][28][29][30] Insufficient data for analysis (n= 2) [31,32] Inappropriate method and data collection (n= 4) [33][34][35][36] No clear comparison group (n= 4) [37][38][39][40] Number of studies included in review (n=13) [41][42][43][44][45][46][47][48][49][50][51][52] Publications handpicked (screening reference list) (n= 2) …”