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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000403-15 | Registry Identifier | EudraCT | |
| U1111-1115-2084 | Registry Identifier | WHO |
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The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.
In the western world, there are several people affected by chronic insomnia. Numerous studies estimate that 30% to 40% of the general population is affected at some time in their lives 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 morbidities 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.
Although normal control of the sleep-wake cycle is exerted by the suprachiasmatic nucleus via melatonin receptor subtype 1 and 2 (MT1 and MT2) receptors (melatonin receptor subtype), most current pharmacologic treatments for insomnia mainly involve GABAergic (gamma-aminobutyric acid) mechanisms. Most currently prescribed sleep agents are benzodiazepine receptor agonists, which induce sleep by binding to the benzodiazepine receptor site of the gamma-aminobutyric acid-A receptor complex. Gamma-aminobutyric acid is the major inhibitory transmitter in the central nervous system, and its receptors are distributed widely throughout the brain. In addition to sleep, benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly related to sleep, depending on the precise subset of gamma-aminobutyric acid-A receptors activated. These include sedative, anxiolytic, muscle-relaxant, and amnesic effects. The risk of tolerance, dependence development, and abuse potential associated with the benzodiazepine receptor agonists also may reflect effects of these drugs on the gamma-aminobutyric acid-A receptor complex.
The sleep-wake cycle results from the interaction of circadian and homeostatic mechanisms. The homeostatic mechanism refers to the accumulation of sleep load during time awake; the organism falls asleep when the sleep load is high, and the reduction of sleep load during sleep results in waking.
A circadian rhythm is superimposed on the homeostatic mechanism. Circadian rhythms are controlled by the suprachiasmatic nucleus, which emits alerting signals; this signal is believed to be attenuated by melatonin, which is produced in response to darkness. It is believed that binding of melatonin to MT1 and MT2 receptors in the suprachiasmatic nucleus inhibits firing of specific neurons, and this is thought to attenuate the alerting signal, allowing the homeostatic mechanism to express itself and promote sleep.
An agent that is selective for the MT1 and MT2 receptors would be expected to be devoid of the ancillary effects of agents that act at the gamma-aminobutyric acid-A receptor complex. It would promote sleep by specifically targeting the alerting signal in the suprachiasmatic nucleus, allowing the homeostatic mechanism to produce sleep.
Ramelteon is under global development by Takeda Pharmaceuticals as a nonscheduled sleep agent for the treatment of difficulty with sleep initiation, and is marketed under the brand name of Rozeremâ„¢ in the United States. In vitro, ramelteon demonstrates affinity and selectivity for human melatonin MT1 and MT2 receptors compared to melatonin. It also demonstrates full agonist activity in cells expressing human MT1 or MT2 receptors relative to melatonin.
In the European Union, Takeda is seeking marketing approval for the long-term treatment of transient and chronic insomnia as characterized by difficulty with sleep onset. Because most of the European clinical studies to date have used the 8 mg dose, the aim of this study is to assess the safety and efficacy of 4mg of ramelteon in a larger number of adults with chronic insomnia.
Subjects participating in this study will be required to report to a sleep laboratory and have polysomnography recordings over two consecutive nights for three sittings during a five week period. The total duration of the study is approximately 10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon 4 mg QD | Experimental |
| |
| Placebo QD | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated. | Nights 1-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured. | Nights 15-16 |
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). |
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Inclusion Criteria:
A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study.
Has a body mass index between 18 and 34, inclusive.
Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
Based on sleep history, the subject reports a history of subjective sleep latency ≥45 minutes and a subjective total sleep time ≤6.5 hours for at least 3 months.
Based on sleep history, the subject's habitual bedtime is between 10:00 PM and 1:00 AM.
On at least 3 of the first 5 nights of single blind run-in placebo treatment, the subject must have an subjective sleep latency of ≥45 minutes and a subjective total sleep time of <6.5 hours.
The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in must be ≤30 minutes.
The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in must be ≤30 minutes.
The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in must be ≤30 minutes.
Is willing to have a fixed bedtime and agrees to go to bed within ± 30 minutes of the habitual bedtime during the entire study, exceptions will be allowed at weekends that are not within 2 days of a polysomnography visit.
Has consistent access to a touch-tone phone and is willing to complete all telephone questionnaires within 60 minutes of wake time each morning throughout the entire duration of the study.
Is willing to remain in bed for at least 6.5 hours each night during the entire study.
Based on sleep history, the subject normally uses pharmacologic assistance to sleep 0 to 4 (maximum allowable) times per week in the last 3 months. Subjects must agree to discontinue the use of all sleep aids beginning 1 week prior to the first dose of single-blind study medication and throughout the entire duration of the study.
The subject must complete the post-sleep questionnaire morning questionnaire on at least 5 of 7 mornings for all 3 weeks of single-blind run-in.
Has a mean latency to persistent sleep of ≥20 minutes on 2 consecutive screening nights, with neither night less than 15 minutes, via polysomnography screening assessment during the single-blind placebo run-in period.
Exclusion Criteria:
Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
Has participated in a study involving ramelteon within 6 months of initial Screening Visit.
Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first night of single-blind study medication.
Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or has flown across greater than 3 time zones within 7 days prior to Screening.
Has participated in a weight loss program or has substantially altered his or her exercise routine within 30 days prior to the first night of single-blind study medication.
Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movements during sleep, chronic obstructive pulmonary disease, fibromyalgia, schizophrenia, bipolar disorder, mental retardation or a cognitive disorder.
Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months.
Has a history of drug addiction or alcohol abuse and/or regularly consumes 4 or more alcoholic drinks per day within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.
Has a current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single blind study medication.
The subject uses tobacco products (including nicotine gum and patch) during nightly awakenings.
The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Has a positive urine drug screen for an illegal substance at the initial Screening Visit.
Has a positive urine drug screen at polysomnography screening or a positive alcohol breathalyzer test at polysomnography screening or randomization.
Exhibits a placebo response during the single-blind placebo run-in period. A placebo response is defined as having:
Has periodic leg movements during sleep with arousal index (per hour of sleep) >10 as seen on polysomnography on the first night of polysomnography screening.
Has any additional condition(s) that in the Investigator's opinion would:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
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| Label | URL |
|---|---|
| Rozerem Package Insert. | View source |
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Sleep quality was assessed by postsleep questionnaires during a 21-day placebo run-in. Subjects were enrolled in Ramelteon or Placebo once-daily (QD) treatment group.
488 subjects entered placebo Run-in Period. 229 failed randomization criteria for entry into double-blind study medication phase of the study. 259 were randomized into the study.
Subjects were enrolled at 19 sites in Europe and Russia from 21 August 2007 to 28 March 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD | Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets. |
| FG001 | Ramelteon 4 mg QD | Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Run-in |
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| Double-Blind Treatment Period |
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| Placebo Run-out |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets. |
| BG001 | Ramelteon 4 mg QD |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated. | The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 1-2 |
|
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No Serious Adverse Events Reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QD | Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr VP, Clinical Science | Takeda Global Research & Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Placebo | Drug | Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks. |
|
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured. |
| Nights 29-30 |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab. | Nights 1-2 |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab. | Nights 15-16 |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30). | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab. | Nights 29-30 |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2). | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 2 |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4). | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 4 |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5). | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 5 |
| Total Sleep Time, Per Polysomnography (Nights 1-2). | All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | Nights 1-2 |
| Total Sleep Time, Per Polysomnography (Nights 15-16). | All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | Nights 15-16 |
| Total Sleep Time, Per Polysomnography (Nights 29-30). | All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | Nights 29-30 |
| Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2). | Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit. | Nights 1-2 |
| Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16). | Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit. | Nights 15-16 |
| Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30). | Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit. | Nights 29 -30 |
| Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2). | Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 2 |
| Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4). | Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 4 |
| Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5). | Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 5 |
| Sleep Efficiency, Per Polysomnography (Nights 1-2). | The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100. | Nights 1-2 |
| Sleep Efficiency, Per Polysomnography (Nights 15-16). | The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100. | Nights 15-16 |
| Sleep Efficiency, Per Polysomnography (Nights 29-30). | The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100. | Nights 29-30 |
| Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2). | Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | Nights 1-2 |
| Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16). | Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | Nights 15-16 |
| Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30). | Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | Nights 29-30 |
| Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2). | The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | Week 2 |
| Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4). | The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | Week 4 |
| Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5). | The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | Week 5 |
| Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2). | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | Nights 1-2 |
| Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16). | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | Nights 15-16 |
| Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30). | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | Nights 29-30 |
| Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2). | Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. | Nights 1-2 |
| Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16). | Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. | Nights 15-16 |
| Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30). | Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. | Nights 29-30 |
| Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2). | The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 2 |
| Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4). | The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 4 |
| Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5). | The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 5 |
| Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2). | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | Nights 1-2 |
| Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16). | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | Nights 15-16 |
| Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30). | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | Nights 29-30 |
| Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2). | Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit. | Nights 1-2 |
| Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16). | Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit. | Nights 15-16 |
| Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30). | Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit. | Nights 29-30 |
| Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2). | The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 2 |
| Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4). | The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 4 |
| Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5). | The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | Week 5 |
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Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| OG001 | Ramelteon 4 mg QD | Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets. |
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| Secondary | Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 15-16 |
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| Secondary | Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 29-30 |
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| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 1-2 |
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| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 15-16 |
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| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30). | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 29-30 |
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| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2). | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 2 |
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| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4). | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 4 |
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| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5). | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 5 |
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| Secondary | Total Sleep Time, Per Polysomnography (Nights 1-2). | All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 1-2 |
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| Secondary | Total Sleep Time, Per Polysomnography (Nights 15-16). | All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 15-16 |
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| Secondary | Total Sleep Time, Per Polysomnography (Nights 29-30). | All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 29-30 |
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| Secondary | Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2). | Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 1-2 |
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| Secondary | Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16). | Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 15-16 |
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| Secondary | Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30). | Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 29 -30 |
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| Secondary | Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2). | Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 2 |
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| Secondary | Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4). | Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 4 |
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| Secondary | Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5). | Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 5 |
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| Secondary | Sleep Efficiency, Per Polysomnography (Nights 1-2). | The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | percentage of time asleep to time in bed | Nights 1-2 |
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| Secondary | Sleep Efficiency, Per Polysomnography (Nights 15-16). | The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | percentage of time asleep to time in bed | Nights 15-16 |
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| Secondary | Sleep Efficiency, Per Polysomnography (Nights 29-30). | The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | percentage of time asleep to time in bed | Nights 29-30 |
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| Secondary | Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2). | Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Nights 1-2 |
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| Secondary | Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16). | Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Nights 15-16 |
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| Secondary | Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30). | Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Nights 29-30 |
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| Secondary | Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2). | The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 2 |
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| Secondary | Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4). | The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 4 |
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| Secondary | Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5). | The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 5 |
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| Secondary | Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2). | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 1-2 |
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| Secondary | Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16). | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 15-16 |
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| Secondary | Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30). | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 29-30 |
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| Secondary | Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2). | Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 1-2 |
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| Secondary | Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16). | Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 15-16 |
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| Secondary | Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30). | Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Nights 29-30 |
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| Secondary | Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2). | The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 2 |
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| Secondary | Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4). | The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 4 |
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| Secondary | Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5). | The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | minutes | Week 5 |
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| Secondary | Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2). | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | awakenings after persistent sleep | Nights 1-2 |
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| Secondary | Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16). | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | awakenings after persistent sleep | Nights 15-16 |
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| Secondary | Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30). | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | awakenings after persistent sleep | Nights 29-30 |
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| Secondary | Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2). | Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | Number of awakenings per night | Nights 1-2 |
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| Secondary | Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16). | Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | Number of awakenings per night | Nights 15-16 |
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| Secondary | Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30). | Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | Number of awakenings per night | Nights 29-30 |
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| Secondary | Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2). | The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 2 |
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| Secondary | Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4). | The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 4 |
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| Secondary | Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5). | The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 5 |
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|
| 0 |
| 129 |
| 34 |
| 129 |
| EG001 | Ramelteon 4 mg QD | Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets. | 0 | 130 | 35 | 130 |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Arrhythmia supraventricular | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Visual disturbance | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Pyrexia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Upper respiratory tract infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Lymphocyte count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Back pain | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Cervicobrachial syndrome | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Post-traumatic headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Early morning awakenings | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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The sponsor can review results communications prior to public release; such communications can be embargoed for a period up to 150 days to permit actions necessary to preserve sponsor's intellectual property. Sponsor can request changes to the results communication only for the purpose of removing non study related information that is proprietary and confidential to sponsor. Sponsor can require delay of a results communication until the study has been completed at all participating sites.