Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ramelteon and doxepin · 4 trials · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Ramelteon 4 mg QD | EXPERIMENTAL | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Ramelteon 8 mg QD | EXPERIMENTAL | - |
| Ramelteon 16 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Doxepin 3 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Doxepin Placebo QD | EXPERIMENTAL | - |
| Ramelteon Placebo QD and Doxepin 3 mg QD | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Ramelteon 4 mg QD and Gabapentin 400 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Gabapentin 800 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Gabapentin Placebo QD | EXPERIMENTAL | - |
| Gabapentin 800 mg QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ramelteon | DRUG | Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks. |
| Placebo | DRUG | Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks. |
| Ramelteon and doxepin | DRUG | Ramelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks. |
| Doxepin | DRUG | Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks. |
| Ramelteon and gabapentin | DRUG | Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week. |
| Gabapentin | DRUG | Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week. |
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 ...
Ramelteon is an investigational small molecule being developed for sleep-related conditions, including transient insomnia, chronic insomnia, sleep initiation and maintenance disorders, and circadian rhythm sleep disorders. It has been studied in Phase 2 and Phase 3 clinical trials for these indications.
Ramelteon is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted multiple clinical trials for the drug across various countries, including the United States, Australia, and several European nations.
Ramelteon has completed Phase 3 clinical trials for chronic insomnia, with a total of five trials completed and no active trials currently ongoing. The drug remains investigational and has not been reported as FDA approved based on the available clinical trial data.
Ramelteon has been studied in five completed trials, including NCT00247390, a Phase 3 study in adults with chronic insomnia, and NCT00325728, a Phase 2 trial in subjects with mild to moderate Alzheimer's disease. Other trials include NCT00593736 for delayed sleep phase syndrome and NCT00671190 in healthy subjects.
Ramelteon is also known by the brand name Rozerem, which is a melatonin receptor agonist used for insomnia. The clinical trials listed for Ramelteon, such as NCT00247390, evaluate the drug's efficacy and safety in conditions like chronic insomnia and circadian rhythm disorders.