Prolonged release melatonin for improving sleep in totally blind subjects: a pilot placebo-controlled multicenter trial.

ABSTRACT:

Introduction

Melatonin, secreted by the pineal gland during the night phase, is a regulator of the biological clock and sleep tendency. Totally blind subjects frequently report severe, periodic sleep problems, with 50%-75% of cases displaying non-24-hour sleep-wake disorder (N24HSWD) due to inability to synchronize with the environmental day-night cycle. Melatonin immediate-release preparations are reportedly effective in N24HSWD. Here, we studied the efficacy and safety of prolonged-release melatonin (PRM), a registered drug for insomnia, for sleep disorders in totally blind subjects living in normal social environments. The primary endpoint was demonstration of clinically meaningful effects on sleep duration (upper confidence interval [CI] limit >20 minutes whether significant or

SUBMITTER: Roth T 

PROVIDER: S-EPMC4319556 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature