Safety of Ramelteon in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease

Inclusion Criteria * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Clinical history of chronic obstructive pulmonary disease and a confirmatory diagnosis based on pulmonary function tests at screening. * Moderate: forced expiratory volume in one second/ forced vital capacity less than 70% and forced expiratory volume 135-75% of predicted. * Post-bronchodilator forced expiratory volume in one second change from baseline of less than 12%. * Negative chest x-ray at screening, other than findings consistent with mild to moderate chronic obstructive pulmonary disease, within the last 6 months. * Arterial oxygen saturation during sleep greater than 85% for at least 99% of the recording period, with no arterial oxygen saturation readings less than 80% as assessed by pulse oximetry at polysomnography screening. * Arterial oxygen saturation during wakefulness greater than 91% (both supine and sitting) as assessed by pulse oximetry at screening. * Habitual bedtime is between 8:30 p.m. and 12:00 a.m. * Body mass index between 18 and 34, inclusive. * Agrees to remain in the study center for three overnight stays. Exclusion Criteria: * Known hypersensitivity to ramelteon or related compounds, including melatonin. * Known hypersensitivity to Ventolin® or related compounds. * 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 study medication, whichever is longer. * Clinical history of acute or chronic respiratory failure, severe chronic obstructive pulmonary disease, or hypercapnia (Partial Pressure of Oxygen in Arterial Blood greater than or equal to45 mmHg). * History of or currently has right ventricular hypertrophy on electrocardiogram or right heart failure. * Periodic leg movement with arousal index (per hour of sleep) greater than 20 as seen at polysomnography screening. * Apnea hypopnea index greater than 15 as seen at polysomnography screening. * Acute clinically significant illness within 2 weeks or has been hospitalized within 4 weeks of study participation. * Sleep schedule changes required by employment 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 medications. * History of seizures, sleep apnea, restless leg syndrome, period limb movement disorder, other known sleep disorders, schizophrenia, bipolar disease, mental retardation, or cognitive disorder. * History of psychiatric disorder 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 and/or regularly consumes 4 or more alcoholic drinks per day. * Unable to discontinue the use of hypnotics for the duration of the study. * Any clinically important abnormal finding, other than chronic obstructive pulmonary disease, as determined by medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator. * 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. * Hematocrit value greater than 55% at screening. * 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 * 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 * Decongestants * Over-the-counter and prescription stimulants * Over-the-counter and prescription diet aids * Central nervous system active drugs and narcotic analgesics * Lipophilic beta blockers * Melatonin * St. John's Wort * Kava-kava * Gingko biloba