Safety of Ramelteon in Elderly Subjects

Inclusion Criteria * Self-reported sleep latency of 30 minutes or greater on at least 3 nights per week during the last 3 months. * Body mass index between 18 and 34, inclusive * Habitual bedtime between 9 pm and 1 am. 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