Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

Exclusion Criteria

• •Known hypersensitivity to Ramelteon or related compounds, including melatonin.
• •Previously participated in a study involving Ramelteon.
• •Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night single-blind study medication, whichever is longer.
• •Sleep schedule changes required by employment (e.g. shift worker) within three months prior to the first night of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
• •Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single blind study medication.
• •Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
• •History of psychiatric disorder (including anxiety or depression) within the past 12 months.
• •History of drug addiction or drug abuse within the past 12 months.
• •History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
• •Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single-blind study medication.
• •Uses tobacco products during nightly awakenings.
• •Used melatonin, or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication.
• •Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
• •Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
• •Positive hepatitis panel.
• •Positive urine drug screen including alcohol at screening or a positive breathalyzer test at each check-in.
• •Apnea hypopnea index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of the polysomnogram screening.
• •Periodic leg movement with arousal index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of polysomnogram screening.
• •Any additional condition(s) that in the Investigator's opinion would:
• •* affect sleep/wake function
• •* prohibit the subject from completing the study
• •* not be in the best interest of the subject.
• •Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
• •* Anxiolytics
• •* Hypnotics
• •* Antidepressants
• •* Anticonvulsants
• •* Sedating H1 antihistamines
• •* Systemic steroids
• •* Respiratory stimulants (eg, theophylline)
• •* Decongestants
• •* Over-the-counter and prescription stimulants
• •* Over-the-counter and prescription diet aids
• •* Central nervous system active drugs (including herbal preparations with central nervous system effects)
• •* Narcotic analgesics
• •* All beta blockers
• •* Melatonin
• •* St. John's Wort
• •* Kavakava
• •* Gingko biloba