None listed
Conditions
Interventions
Intervention1: Ramelteon: 8 mg tablet once daily for 10 days
Control Intervention1: Zolpidem : 10 mg tablet once daily for 10 days
Sponsors
Ranbaxy Laboratories Ltd., Plot No.20, Sector 18, Udyog Vihar Industrial Area, Gurgaon - 122015 , Haryana, India
Eligibility
Inclusion criteria
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 Rhythm Sleep Disorder or a Parasomnia. 4. The disturbance does not occur exclusively during the course of another mental disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder, a Delirium). 5. The disturbance is not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to ramelteon or related compounds including melatonin, zolpidem or other non-benzodiazepines with imidazopyridine class. 2. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening. 3. Patients with clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness (es). 4. Patients with current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia. 5. Patients who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea. 6. Patients with SGOT/AST or SGPT/ALT, total serum bilirubin or serum alkaline phosphatase > 1.5 times upper limit of normal or serum creatinine >1.2 times upper limit of normal. 7. Patients receiving treatment with cytochrome P450 enzyme inhibitor drugs like fluvoxamine, itraconazole, ketoconazole, fluconazole or enzyme inducer like rifampin during the last 14 days prior to screening. 8. Patients currently receiving treatment with zolpidem or ramelteon or its related compounds. 9. Patients receiving treatment with flurazepam, sertraline and other CNS depressants during last 3 weeks prior to screening. 10. Patients who have received following medications in the period shown in parentheses : Triazolam (1 day); Alprazolam (2 days); Chlordiazepoxide (2 days); Temezepam (2 days); Estazolam (3 days); Lorazepam (3 days); Diazepam (7 days). 11. Patients with substance dependence/ abuse in the past one year or with alcohol abuse are ineligible. 12. Patients using tobacco products during night awakenings. 13. Patients with history of seizures or significant head trauma. 14. Patients who travelled across 4 or more time zones or worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period. 15. Patients in whom another investigational drug was used within three months prior to entry in this study. 16. Patients who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Sleep Onset.Timepoint: At the end of 10±2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
India
Contacts
Public ContactKanchan Tyagi
Outcome results
None listed