Overview
Ramelteon is the first in a new class of sleep agents that selectively binds to the melatonin receptors in the suprachiasmatic nucleus (SCN). It is used for insomnia, particularly delayed sleep onset. Ramelteon has not been shown to produce dependence and has shown no potential for abuse.
Indication
用于失眠症，特别适用于治疗难以入睡型失眠症。
Associated Conditions
- Insomnia
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2011/11/09 | Phase 3 | Terminated | |||
2011/11/09 | Phase 3 | Terminated | |||
2011/07/25 | Phase 4 | Completed | Sleep Medicine Centers of WNY | ||
2010/09/22 | Phase 4 | UNKNOWN | Kessler Foundation | ||
2010/08/12 | Phase 4 | UNKNOWN | |||
2010/05/24 | Phase 3 | UNKNOWN | Southern Arizona VA Health Care System | ||
2010/01/13 | Phase 3 | Completed | |||
2009/06/05 | Phase 1 | Completed | |||
2009/06/05 | Phase 2 | Completed | |||
2009/05/22 | Not Applicable | Withdrawn |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0343 | ORAL | 8 mg in 1 1 | 6/15/2023 | |
| i3 Pharmaceuticals, LLC | 72319-005 | ORAL | 8 mg in 1 1 | 4/28/2023 | |
| Bryant Ranch Prepack | 71335-1853 | ORAL | 8 mg in 1 1 | 8/16/2021 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0203 | ORAL | 8 mg in 1 1 | 11/11/2022 | |
| Zydus Lifesciences Limited | 70771-1495 | ORAL | 8 mg in 1 1 | 9/27/2023 | |
| Unit Dose Services | 50436-3980 | ORAL | 8 mg in 1 1 | 1/12/2022 | |
| Asclemed USA, Inc. | 76420-628 | ORAL | 8 mg in 1 1 | 11/27/2023 | |
| TruPharma, LLC | 52817-235 | ORAL | 8 mg in 1 1 | 4/28/2023 | |
| Takeda Pharmaceuticals America, Inc. | 64764-805 | ORAL | 8 mg in 1 1 | 11/12/2021 | |
| Physicians Total Care, Inc. | 54868-5649 | ORAL | 8 mg in 1 1 | 1/20/2010 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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