Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia Inclusion Criteria Exclusion Criteria Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds Yes
No
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 Yes
No
Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication Yes
No
Flown across greater than three time zones within 7 days prior to or during screening Yes
No
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 Yes
No
Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia Yes
No
History of psychiatric disorder within the past 6 months Yes
No
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 Yes
No
History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised Yes
No
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 Yes
No
Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night Yes
No
Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night Yes
No
Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits Yes
No
Positive breathalyzer test on any of the polysomnogram assessment visits Yes
No
Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings Yes
No
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. Yes
No
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 Yes
No
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: Yes
No
Anxiolytics Yes
No
Sedatives Yes
No
Hypnotics Yes
No
CNS active drugs (including herbal) Yes
No
Antidepressants Yes
No
Narcotic analgesics Yes
No
Anticonvulsants Yes
No
Beta blockers Yes
No
Sedating H1 antihistamines Yes
No
St. John's Wort Yes
No
Systemic steroids Yes
No
Kava-kava Yes
No
Respiratory stimulants Yes
No
Ginkgo-biloba Yes
No
Decongestants Yes
No
Over-the-counter and prescription stimulants Yes
No
Antipsychotics Yes
No
Over-the-counter and prescription diet aids Yes
No
Muscle Relaxants Yes
No
Melatonin and all other drugs or supplements known to affect sleep/wake function Yes
No
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 Yes
No
History of hepatitis B or hepatitis C Yes
No
