Safety of Ramelteon in Elderly Subjects

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Aged, Postural Balance, Drug Therapy Read More

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