A clinical trial to study the effects of Ramelteon in patients of insomnia

INTERVENTION: Intervention1: Ramelteon: 8 mg tablet once daily for 10 days Control Intervention1: Zolpidem : 10 mg tablet once daily for 10 days CONDITION: Insomnia PRIMARY OUTCOME: Time to Sleep Onset.‐‐‐‐‐‐Timepoint: At the end of 10±2 days SECONDARY OUTCOME: ‐ Total sleep duration.; ‐ Nocturnal awakenings after sleep onset (NAASO).; ‐ Difficulty in falling asleep.; ‐ Mental alertness on rising.; ‐ sleep quality.; ‐‐‐‐‐‐Timepoint: At the end of 10±2 days INCLUSION CRITERIA: Patients of either sex, aged 18 to 60 years, suffering from insomnia characterized by the following criteria at the time of randomization 1. Diagnosis of primary insomnia based on DSM‐IV* criteria. 2. More than 30 minutes to fall asleep and subjective total sleep time of ≤ 6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep. 3. Habitual bedtime between 8.30 pm and midnight. 4. Body Mass Index between 16.5 to 30# * DSM‐IV Diagnostic criteria for Primary Insomnia 1. The predominant complaint is difficulty initiating or maintaining sleep, or nonrestorative sleep, for at least 1 month. 2. The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning. 3. The sleep disturbance does not occur exclusively during the course of Narcolepsy, Breathing‐Related Sleep Disorder, Circadian Rhy