TheraRadar
Data updated: May 26, 2026

RAMELTEON

Melatonin Receptor Agonists
Sleep Approved 2013-07-26

RAMELTEON is indicated for the treatment of Insomnia.

Source: FDA Label • GRANULES • Melatonin Receptor Agonist
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How RAMELTEON Works

Ramelteon is a selective melatonin MT

Source: FDA Label
10
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2013-07-26
Routes
ORAL
Dosage Forms
TABLET

Companies

GRANULES Aurobindo Pharma I3 PHARMS XIROMED ZYDUS PHARMS Teva Dr. Reddy's APPCO MICRO LABS ANDAS 5 HOLDING
Active Ingredient: RAMELTEON

RAMELTEON Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2013 to 2026
Apr 2026 SUPPL
Label · Labeling
Jul 2023 ORIGINAL
Update
Apr 2023 SUPPL
Label · Labeling

What RAMELTEON Treats

1 indications

RAMELTEON is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Insomnia
Source: FDA Label

RAMELTEON Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

TASIMELTEON
Apotex
2022 1 indic.
HETLIOZ LQ
VANDA PHARMS
2020 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

QUVIVIQ
IDORSIA
2022 1 indic.
DAYVIGO
EISAI INC
2019 1 indic.
Unlock 9 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RAMELTEON

3 of 17

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMBIEN
ZOLPIDEM TARTRATE
1 shared
COSETTE
Shared indications:
Insomnia
AMBIEN CR
ZOLPIDEM TARTRATE
1 shared
COSETTE
Shared indications:
Insomnia
BELSOMRA
SUVOREXANT
1 shared
Merck
Shared indications:
Insomnia
View all 17 similar drugs Pro
📋

Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT07382843 C202205038 Ph 4 completed Melatonin Agonist for Shift-time Workers.
NCT06512363 LMTAP2022-III Ph 3 not yet recruiting A Study of Ramelteon in Chinese Patients With Chronic Insomnia
NCT03931070 1364075 Ph 4 completed The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU
NCT03265951 DORMI RF-1070471 Ph 4 withdrawn Ramelteon for Complex Insomnia in Veterans With PTSD
NCT02324153 RECOVER results posted IRB00097232 1R21AG050850-01A1 Ph 2 completed Ramelteon in the Prevention of Post-operative Delirium
NCT03165695 2017P000656 Ph 4 withdrawn Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
NCT02560324 RAP results posted 823286 R21DA040902 Ph 2 completed Effect of Ramelteon on Smoking Abstinence
NCT02669082 results posted Ramelteon-4002 JapicCTI-163143, U1111-1177-4116 Ph 4 completed The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
NCT02840591 042016-063 Ph 4 withdrawn Ramelteon and Citicoline for Delirium
NCT00539110 Sleep3 results posted 09-04-07-01 Ph 2 completed Differential Effects of Zolpidem Versus Ramelteon in Burned Children
NCT01677182 results posted TAK-375SL_301 2012-001357-10, U1111-1129-5184 Ph 3 terminated Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
NCT00893269 NA_00017909 R21DA025794 Ph 1 completed The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
NCT00622427 results posted F071204001 Ph 4 completed Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
NCT00869167 results posted 07-052R Ph 3 terminated Ramelteon for Insomnia Comorbid With Asthma
NCT00595504 results posted 2007P-001929 FWA00003136 Ph 4 completed Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
NCT00739024 results posted CRC 0690 Ph 2 terminated A Study of a Melatonin Receptor Agonist to Prevent Migraine
NCT00914862 results posted TAK-375_110 U1111-1112-5188 Ph 1 completed Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
NCT01401413 NEU1640207B Ph 4 completed Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RAMELTEON FDA Label Details

Indications & Usage

RAMELTEON is indicated for the treatment of Insomnia.

Looking for the branded version?

ROZEREM

Full clinical data, patents, trials, and competitive landscape for ramelteon.

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Data Sources

FDA Approval: ANDA213186 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.