Efficacy of Ramelteon in Subjects With Chronic Insomnia

Exclusion Criteria

• •Known hypersensitivity to Ramelteon or related compounds, including melatonin.
• •Participated in any other investigational study, and/or taken any investigational drug within 30 days or five half-lives prior to Day 1 of study medication, whichever is longer. The only exception to this is prior participation in an allowed Ramelteon study.
• •Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 of 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 Day 1 of study medication.
• •Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, 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 with the past 12 months.
• •History of alcohol abuse within the past 12 months, as defined in the 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 Day 1 of study medication.
• •Uses tobacco products during nightly awakenings.
• •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.
• •Any additional condition(s) that in the Investigator's opinion would:
• •* affect sleep/wake function
• •* prohibit the subject from completing the study, or
• •* not be in the best interest of the subject to participate in the study.
• •Morning serum cortisol at the Baseline visit of less than 7.0 micro-g per dl.
• •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
• •* Narcotic analgesics
• •* Beta blockers
• •* St. John's Wort
• •* Kava-kava
• •* Gingko biloba
• •* Melatonin