Jatin R Joshi
University of Oxford, UK
Title: A prospective, interventional, randomised, parallel, double blind and placebo controlled clinical trial to evaluate the efficacy and safety of low dose fine mist sublingual melatonin (Instavit®, London, UK) in the treatment of occasional sleeplessness
Biography
Biography: Jatin R Joshi
Abstract
Introduction: Sleep disorders affect over 70 million people in the USA representing 20% of the population. The problem has
been deemed a public health epidemic by the Center for Disease Control and Prevention (CDC) contributing to a host of
medical conditions including cancer, obesity, diabetes, depression, and hypertension.
Objective: To review the effectiveness and safety of low dose (0.8 mg) fine mist sublingual Melatonin for the treatment of
occasional sleeplessness.
Method: 50 subjects were selected for a single center, prospective; double-blind randomized controlled trial assessing the safety
and efficacy of low dose, fine mist sublingual melatonin spray versus placebo. Subjects were randomly allocated to one of two
arms and sleep quality was assessed over a 28-day period using sleep logs, sleep diaries and the Insomnia Severity Index.
Result: All 50 participants completed the trial and varying degrees of sleeplessness was noted at baseline. Low dose fine mist
sublingual Melatonin spray had a significant effect on the time taken to fall asleep within 30 minutes; 92% low dose, fine mist
melatonin, 23% placebo (p<0.001); sleep duration of more than 7 hours; 96% low dose, fine mist melatonin, 32% placebo
(p<0.001) and good/excellent sleep quality; 92% low dose, fine mist melatonin, 24% placebo (p<0.001). No adverse effects were
noted.
Conclusion: The results show that low dose, fine mist sublingual melatonin spray is very effective in the treatment of occasional
sleeplessness and results in less time taken to fall asleep, increased sleep duration and sleep quality versus placebo.