Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea

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