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 day of single-blind study medication, whichever is longer.
• •Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day 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 day of single-blind study medication.
• •Has 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 within the past 12 months.
• •History of alcohol abuse within the past 12 months.
• •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 day of single-blind 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 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 that may interfere with evaluation of the study medication, including:
• •* melatonin or other drugs or supplements known to affect sleep/wake function.
• •* anxiolytics
• •* hypnotics
• •* antidepressants
• •* anticonvulsants
• •* sedating H1 antihistamines
• •* systemic steroids
• •* respiratory stimulants and 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
• •* beta blockers
• •* melatonin
• •* St. John's Wort
• •* kava-kava
• •* gingko biloba