A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
An ideal treatment for chronic insomnia would include administration of therapy for an extended period. Specifically, it should be safe and effective for a period longer than the 7 to 10 days to which use of the current drugs approved for short-term use are limited.
Because of the absence of evidence of residual effects in pre-clinical studies and phase 2 and 3 clinical trials, ramelteon may be a candidate for extended use. As chronic insomnia becomes more prevalent, there is a need to assess the long-term efficacy and safety of nightly dosing with ramelteon in the general population. Study participation is anticipated to be about 8 months and 3 weeks.
Inclusion Criteria
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:
Any additional condition(s) that in the Investigator's opinion would
History of hepatitis B or hepatitis C.
Victoria, Australia
Ostrava-Poruba, Czechia
Yekateringburg, Russia