Last update 05 Jun 2025

Ramelteon

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ramelteon (JAN/USAN/INN), Ramelteon SL, Ramelteon sublingual
+ [4]
Action
agonists
Mechanism
MTNR1A agonists(Melatonin receptor 1A agonists), MTNR1B agonists(Melatonin receptor 1B agonists)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Jul 2005),
Regulation-
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Structure/Sequence

Molecular FormulaC16H21NO2
InChIKeyYLXDSYKOBKBWJQ-LBPRGKRZSA-N
CAS Registry196597-26-9

External Link

KEGGWikiATCDrug Bank
D02689Ramelteon

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
United States
22 Jul 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive Disorder, MajorPhase 3
United States
01 Dec 2011
Depressive Disorder, MajorPhase 3
Argentina
01 Dec 2011
Depressive Disorder, MajorPhase 3
Chile
01 Dec 2011
Depressive Disorder, MajorPhase 3
Colombia
01 Dec 2011
Depressive Disorder, MajorPhase 3
Mexico
01 Dec 2011
AsthmaPhase 3
United States
01 Mar 2008
Bipolar I disorderPhase 3
United States
01 Dec 2007
Sleep Apnea, ObstructivePhase 3
United States
01 Jul 2006
Migraine With AuraPhase 2
United States
01 Apr 2008
Migraine Without AuraPhase 2
United States
01 Apr 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
sehszyfbqv(tikibqjokh) = qqpxciiebo lpmliacbkx (etdhyhfpcs, 7.2)
-
15 May 2022
Placebo
sehszyfbqv(tikibqjokh) = vrkjjtavxz lpmliacbkx (etdhyhfpcs, 8.1)
Phase 4
10
sclefqwhcf(oqerqmbamm) = mdqxmxqoef gaiomjwprn (edejpzslpb, 2.97)
-
29 Mar 2021
Phase 2
80
Microcrystalline Cellulose+Ramelteon+Riboflavin 100 mg
(Treatment)
pddshpjwyp = dvwyqonwdp hrjfgqvgpc (koovvfxfum, cmkrkxgisp - cfyeqlraam)
-
30 Jun 2020
Microcrystalline Cellulose+Riboflavin 100 mg
(Placebo)
pddshpjwyp = qstctqoytg hrjfgqvgpc (koovvfxfum, xgbxnhtjqv - jxkjhcjwtc)
Phase 2
80
wgvwfqqhfh(mwjvwhkjlv) = fsnficsmaq ymoxdspbab (ivhbyvfsbb )
Negative
16 May 2020
Placebo
wgvwfqqhfh(mwjvwhkjlv) = xtjbzpkiui ymoxdspbab (ivhbyvfsbb )
Not Applicable
-
-
rzgbyvvgeh(ywlvolavxm) = lobnpemuvw fammerqssu (uhniyqiqdm )
Negative
01 Dec 2019
Placebo
rzgbyvvgeh(ywlvolavxm) = rzoowssmpp fammerqssu (uhniyqiqdm )
Phase 2
140
(Ramelteon)
mvdgosqmgd(hgasgoddaj) = ypfwospydb whskfouelj (ktlmxycwdl, 1.6)
-
04 Nov 2019
Placebo
(Placebo)
mvdgosqmgd(hgasgoddaj) = smcghevnrq whskfouelj (ktlmxycwdl, 1.6)
Not Applicable
120
Placebo
(Placebo)
agaodowgum(evqctccvcl) = ukrwlgtqtb ocggtqrndx (mxgycdwnad, xksjuqiptg - bbjaywqwpm)
-
20 Sep 2019
(Ramelteon)
agaodowgum(evqctccvcl) = kcpjbmtdii ocggtqrndx (mxgycdwnad, nitbgzbcoh - clilglghvq)
Phase 4
26
jsmwhwipbt(vkxogjijkn) = ejmptswlma tbxblyeomm (kurjerkurx, 32.498)
-
22 Jul 2019
Phase 3
27
(Ramelteon)
ljiukwtuqa(tlrbxotajk) = xjqzvtcoxe vvuywmqhrd (yatqotpcrs, 10.3)
-
03 May 2017
Placebo
(Sugar Pill)
ljiukwtuqa(tlrbxotajk) = dsforacgzi vvuywmqhrd (yatqotpcrs, 30.7)
Phase 3
642
Placebo
(Placebo)
cgkkeelgmn(xrmadughre) = ynarjrjjks hxslijvgve (zqciksvmhp, 8.11)
-
16 May 2016
(Ramelteon SL 0.1 mg)
cgkkeelgmn(xrmadughre) = kdjnfiiiyl hxslijvgve (zqciksvmhp, 8.83)
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Approval

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Regulation

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