Ramelteon

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

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Ramelteon in Chinese Patients With Chronic Insomnia	2024/07/22	NCT06512363	Phase 3	Not yet recruiting	Nanjing Chia-tai Tianqing Pharmaceutical
Insomnia Prevalence and Treatment Impact on Systemic Hypertension	2022/06/10	NCT05414864	Phase 4	Terminated	University of Sao Paulo
Delirium Reduction With Ramelteon	2021/10/06	NCT05069428	Phase 4	Recruiting	Centennial Medical Center
Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19	2020/07/14	NCT04470297	Phase 2	UNKNOWN	Associação Fundo de Incentivo à Pesquisa
The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU	2019/04/30	NCT03931070	Phase 4	Completed	Rhode Island Hospital
The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia	2018/03/09	NCT03461042	Phase 4	Completed	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Ramelteon for Complex Insomnia in Veterans With PTSD	2017/08/29	NCT03265951	Phase 4	Withdrawn	State University of New York at Buffalo
Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults	2017/05/24	NCT03165695	Phase 4	Withdrawn	Brigham and Women's Hospital
Ramelteon for Treatment of Insomnia in Cirrhosis	2017/03/27	NCT03091738	Phase 4	Completed	Virginia Commonwealth University
Ramelteon and Citicoline for Delirium	2016/07/21	NCT02840591	Phase 4	Withdrawn	University of Texas Southwestern Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ramelteon	Bryant Ranch Prepack	63629-8531	ORAL	8 mg in 1 1	11/12/2021
Ramelteon	Bryant Ranch Prepack	72162-2169	ORAL	8 mg in 1 1	12/11/2023
Ramelteon	Westminster Pharmaceuticals, LLC	69367-356	ORAL	8 mg in 1 1	9/8/2023
Ramelteon	Bryant Ranch Prepack	71335-2186	ORAL	8 mg in 1 1	1/12/2022
Ramelteon	AvPAK	50268-708	ORAL	8 mg in 1 1	5/6/2022
Ramelteon	AvKARE	42291-776	ORAL	8 mg in 1 1	1/10/2024
Rozerem	Rebel Distributors Corp	21695-183	ORAL	8 mg in 1 1	10/8/2009
Ramelteon	Direct_Rx	72189-369	ORAL	8 mg in 1 1	3/10/2023
Ramelteon	Bryant Ranch Prepack	72162-2176	ORAL	8 mg in 1 1	12/11/2023
Ramelteon	Dr.Reddys Laboratories Inc	43598-741	ORAL	8 mg in 1 1	12/8/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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