Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

Exclusion Criteria

• •Any history of insomnia.
• •Spent one or more nights in a sleep laboratory.
• •Epworth Sleepiness Scale score of greater than 10.
• •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, whichever is longer.
• •Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening.
• •Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day 1.
• •History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
• •History of a psychiatric disorder (including anxiety or depression) within the past 12 months.
• •History of drug addiction or drug abuse within the past 12 months.
• •Any physical or psychiatric disorder that may be associated with sleep disturbance.
• •History of alcohol abuse within the past 12 months, as defined in 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.
• •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.
• •Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in.
• •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
• •* 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
• •* All beta blockers
• •* St. John's Wort
• •* Kava-kava
• •* gingko biloba