Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

Inclusion Criteria 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. Body mass index between 18 and 34, inclusive. Based on sleep history, has had chronic insomnia for at least 3 months. Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min and a subjective total sleep time less than or equal to 6.5 hours. Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM. Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes. Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months. Exclusion Criteria Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds. 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. Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication. Flown across greater than three time zones within 7 days prior to or during screening. Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication. Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia. History of psychiatric disorder within the past 6 months. History of alcohol abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits. History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised. Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication. Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night. Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night. Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits. Positive breathalyzer test on any of the polysomnogram assessment visits. Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings. Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders. Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and over the counter medications taken in the three weeks prior to screening. 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: Anxiolytics Sedatives Hypnotics CNS 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 Melatonin and all other drugs or supplements known to affect sleep/wake function Any additional condition(s) that in the Investigator's opinion would affect sleep/wake function prohibit the subject from completing the study indicate that continuation in the study would not be in the best interests of the subject. History of hepatitis B or hepatitis C.