Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
• Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes.
• Body mass index between 18 and 34, inclusive.

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