Safety of Ramelteon in Elderly Subjects

Exclusion Criteria

• •Performance outside of normal limits on the EquiTest Motor Control Test at the Screening Visit.
• •Average score on the EquiTest Sensory Organization Test #5 of less than 40 at the Screening Visit.
• •Average score on the EquiTest Sensory Organization Test #6 of less than 40 at the Screening Visit.
• •History of sleep apnea, restless leg syndrome, period limb movement syndrome, or other known disorders which affect sleep with the exception of insomnia.
• •Current vestibular system disorder or inner ear disease.
• •Recent history of clinically significant head injury.
• •Significant visual acuity or field abnormalities that are not improved with the use of corrective lenses.
• •History of balance disturbance or frequent falling.
• •History of seizures, strokes, degenerative neurological disease, fibromyalgia, diabetic neuropathy, thyroid dysfunction, hypotension, clinically significant arthritis or musculoskeletal disorder.
• •History of cancer, other than basal cell carcinoma, that has not been in remission for at least five years prior to the first dose of study drug.
• •Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable.
• •Acute clinically significant illness within two weeks or has been hospitalized within four weeks prior to the Screening Visit.
• •History of treatment for a psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past six months.
• •History of drug addiction or drug abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.
• •History of alcohol abuse within the past 12 months.
• •Any clinically important abnormal finding, as determined by medical history, physical examination, electrocardiogram or clinical laboratory tests, as determined by the investigator.
• •Positive hepatitis panel.
• •Positive urine drug screen for drugs known to alter sleep.
• •Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
• •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 and all other drugs or supplements known to affect sleep/wake function
• •* Anxiolytics
• •* Sedatives
• •* Hypnotics
• •* Central nervous system active drugs (including herbal)
• •* Antidepressants
• •* Narcotic analgesics
• •* Anticonvulsants
• •* Beta blockers
• •* Sedating H1 antihistamines
• •* St. John's Wort
• •* Systemic steroids
• •* Kava-kava
• •* Respiratory stimulants
• •* Ginkgo-biloba
• •* Decongestants
• •* Over-the-counter and prescription stimulants
• •* Antipsychotics
• •* Over-the-counter and prescription diet aids
• •* Muscle relaxants