Safety and Efficacy of Ramelteon in Elderly Subjects 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 Day 1 of single-blind study medication, whichever is longer.
• •Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 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 Day 1 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.
• •Had an acute clinically significant illness, as determined by the investigator, within 30 days prior to Day 1 of single-blind study medication.
• •Current significant neurological (including cognitive and psychiatric disorders), 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 single-blind study medication.
• •Used tobacco products within 90 days prior to Day 1 of single-blind study medication.
• •Used melatonin, or other drugs or supplements known to affect sleep/wake function, or has consumed grapefruit or grapefruit juice within 5 days (or 5 half lives, whichever is longer) prior to Day 1 of single-blind study medication.
• •Used any central nervous system medication within 3 weeks (or 5 half lives of the drug, whichever is longer) prior to Day 1 of singleblind 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 including anti-hepatitis A virus (only immunoglobulin M is exclusionary), anti- hepatitis B surface (except in subjects who have received hepatitis B virus vaccination), hepatitis B surface antigen, anti- hepatitis B core (only immunoglobulin M is exclusionary), or anti-hepatitis C virus.
• •Positive urine drug screen including alcohol at screening and each check-in or a positive breathalyzer test at each check-in.
• •Apnea hypopnea index (per hour of sleep) greater than 15 as seen on polysonography, on the first night of the polysonography screening.
• •Periodic leg movement with arousal index (per hour of sleep) greater than 20 as seen on polysonography, on the first night of polysonography screening.
• •Any additional condition(s) that in the Investigator.s opinion would: a) affect sleep/wake function, b) prohibit the subject from completing the study, or c) not be in the best interest of the subject to participate in the study.
• •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:
• •* Within 3 weeks prior to Day 1 of single-blind study medication and during the study:
• •* anxiolytics
• •* hypnotics
• •* antidepressants
• •* anticonvulsants
• •* sedating H1 antihistamines
• •* systemic steroids
• •* respiratory stimulants (eg, theophylline) 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
• •* St. John.s wort
• •* kava-kava
• •* gingko biloba, any other supplements
• •* Within 5 days prior to Day 1 of single-blind study medication and during the study:
• •* melatonin, or other drugs or supplements known to affect sleep/wake function.