Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia Einschlusskriterien Ausschlusskriterien Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds Ja
Nein
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 Ja
Nein
Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication Ja
Nein
Flown across greater than three time zones within 7 days prior to or during screening Ja
Nein
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 Ja
Nein
Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia Ja
Nein
History of psychiatric disorder within the past 6 months Ja
Nein
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 Ja
Nein
History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised Ja
Nein
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 Ja
Nein
Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night Ja
Nein
Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night Ja
Nein
Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits Ja
Nein
Positive breathalyzer test on any of the polysomnogram assessment visits Ja
Nein
Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings Ja
Nein
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. Ja
Nein
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 Ja
Nein
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: Ja
Nein
Anxiolytics Ja
Nein
Sedatives Ja
Nein
Hypnotics Ja
Nein
CNS active drugs (including herbal) Ja
Nein
Antidepressants Ja
Nein
Narcotic analgesics Ja
Nein
Anticonvulsants Ja
Nein
Beta blockers Ja
Nein
Sedating H1 antihistamines Ja
Nein
St. John's Wort Ja
Nein
Systemic steroids Ja
Nein
Kava-kava Ja
Nein
Respiratory stimulants Ja
Nein
Ginkgo-biloba Ja
Nein
Decongestants Ja
Nein
Over-the-counter and prescription stimulants Ja
Nein
Antipsychotics Ja
Nein
Over-the-counter and prescription diet aids Ja
Nein
Muscle Relaxants Ja
Nein
Melatonin and all other drugs or supplements known to affect sleep/wake function Ja
Nein
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 Ja
Nein
History of hepatitis B or hepatitis C Ja
Nein
