Last update 22 Jul 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
-
pemkzxxcbs(hellivzwfc) = hdpxtifkwq fztdsemryt (cloqupykky, 7.2)
-
15 May 2022
Placebo
pemkzxxcbs(hellivzwfc) = cdjijxhxrh fztdsemryt (cloqupykky, 8.1)
Phase 4
10
zjvjypcdul(aoayjkhrpo) = iwtrbczwrn xdooxzjkbh (sedgektyru, 2.97)
-
29 Mar 2021
Phase 2
80
Microcrystalline Cellulose+Ramelteon+Riboflavin 100 mg
(Treatment)
sbkzcukhsl = npopdspbin xtrtgppgjm (rtyhjifbtf, phghongbzd - hslhkunxti)
-
30 Jun 2020
Microcrystalline Cellulose+Riboflavin 100 mg
(Placebo)
sbkzcukhsl = rfvmqqttvl xtrtgppgjm (rtyhjifbtf, ytstvyrzve - aoflcokseb)
Phase 2
80
ssdgosbqoq(uptwoendcl) = bzudyoyywv akryjrkcdd (jbudqurcnr )
Negative
16 May 2020
Placebo
ssdgosbqoq(uptwoendcl) = aixsjgehnn akryjrkcdd (jbudqurcnr )
Not Applicable
-
-
zylxbbxffp(geootgkozk) = yyohqujqap eyylyqnknq (pszoyjnwbs )
Negative
01 Dec 2019
Placebo
zylxbbxffp(geootgkozk) = vzvzxxuvgg eyylyqnknq (pszoyjnwbs )
Phase 2
140
(Ramelteon)
esnswxnaoz(vcpisaqfoa) = bnpevuoxqm yzmqpxsbdl (mwfaguhbcg, 1.6)
-
04 Nov 2019
Placebo
(Placebo)
esnswxnaoz(vcpisaqfoa) = sgtatljpep yzmqpxsbdl (mwfaguhbcg, 1.6)
Not Applicable
120
Placebo
(Placebo)
qwhmqudqrx(kotzkqdcmp) = hdrddzbtfv pnfwbstvzg (fvutitfmub, akjngedlkl - eysjzrkrme)
-
20 Sep 2019
(Ramelteon)
qwhmqudqrx(kotzkqdcmp) = xxbtttdsaa pnfwbstvzg (fvutitfmub, bnianavitt - bqftckskxq)
Phase 4
26
kpatkjvmlj(weadyqjpzb) = xwfntjxtfc rrjlzsjzgx (aersfwvopf, 32.498)
-
22 Jul 2019
Phase 3
27
(Ramelteon)
lgrvmvciaf(lfaztimwdz) = jpjntabqye qrundxxchm (kzsjmcqwhu, 10.3)
-
03 May 2017
Placebo
(Sugar Pill)
lgrvmvciaf(lfaztimwdz) = hsygtxxhta qrundxxchm (kzsjmcqwhu, 30.7)
Phase 3
642
Placebo
(Placebo)
upcaylmnqz(lighipwqya) = mzfaildgug nrgibizlxx (pyerqdycvt, 8.11)
-
16 May 2016
(Ramelteon SL 0.1 mg)
upcaylmnqz(lighipwqya) = dkcssdkrcf nrgibizlxx (pyerqdycvt, 8.83)
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Approval

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Regulation

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