A PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY & SAFETY OF INSTAVIT® SWEET DREAMS ORAL SPRAY IN THE TREATMENT OF OCCASIONAL SLEEPLESSNESS.”

*Dr. Harisha S., Director

ABSTRACT

Background: NEW Instavit® Sweet Dreams is a Melatonin based oral spray supplement that has been physician formulated. It is designed to promote a natural sleep cycle and a soothing night’s sleep with just 2 sprays. Melatonin is a natural hormone made by the pineal gland, a small gland in the brain. Melatonin helps control your sleep and wake cycles. Melatonin is sometimes called the "Dracula of hormones" - it only comes out in the dark. Objectives: The aim of the study is to evaluate the safety and efficacy of Instavit sweet Dreams oral spray in the treatment of occasional sleeplessness. Conclusion: Considering all data evaluations for Primary and secondary end-points it has been clearly determined that Instavit sweet Dreams oral spray is more efficacious than Placebo in the treatment of occasional sleeplessness. All the scales used i.e., Insomnia Severity Index, Pittsburgh Insomnia scale and Epworth sleepiness scale showed improvement in the sleeping disorders of the patients for Instavit sweet Dreams oral spray arm up to major extent in comparison to Placebo arm. No serious adverse events were observed during the clinical trial, though 6 adverse events were reported in Visit II and 7 adverse events were reported in Visit III but none of them is related with the study drug and this concludes that investigational product is safe enough to use.

Keywords: Melatonin, End of Treatment (EOT) seasonal affective disorder (SAD).