A Randomized, Double Blind, Placebo Controlled Interventional Clinical Study to evaluate the efficacy and safety of Investigational Product SLEPOVIN in patients with Insomnia

Sleep disorders are a common ailment in currentsociety, one that has significant implications for public health1. Insomnia,the most common of those sleep disorders, is defined by the Diagnostic andStatistical Manual of Mental Disorders, Fourth Edition as difficultyinitiating sleep, difficulty maintaining sleep, or difficulty obtainingrestorative sleep with associated daytime dysfunction or distress due to thatlack of sleep2. It is associated with significant health problemsincluding reduced quality of life, work productivity, and mental health.Insomnia has a high prevalence in society; and although numbers vary,approximately two thirds of adults will have one or more episodes of insomniaeach year, and approximately 15% of adults per year will have a serious chronicepisode3. Insomnia is the most common sleep disorder affectingmillions of people as either a primary or comorbid condition4.Insomnia has been considered as both a symptom and a disorder, and thisdistinction may affect its conceptualization from both research and clinical perspectives.Thecurrent therapeutic options in Insomnia patients include pharmacological,psychological, and complementary approaches. Pharmacologic medications includebenzodiazepine hypnotics, non-benzodiazepine, and melatonin receptor agonists.  Due to associated adverse events withpharmacologic treatments, insomnia patients are switching to alternativetherapy such as herbal medications, alternative therapy encompasses a varietyof disciplines that include everything from diet and exercise to mental conditioningand lifestyle changes such as acupuncture, guided imagery, yoga, hypnosis, biofeedback, aromatherapy, relaxation, herbalremedies, massage, and many others.