Last update 21 May 2025

Lemborexant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAYVIGOTM, LEM, Lemborexant (JAN/USAN/INN)
+ [5]
Action
antagonists
Mechanism
Orexin receptor antagonists
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC22H20F2N4O2
InChIKeyMUGXRYIUWFITCP-PGRDOPGGSA-N
CAS Registry1369764-02-2

External Link

KEGGWikiATCDrug Bank
D11022Lemborexant

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
Canada
03 Sep 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Emergence DeliriumPhase 2
Canada
01 May 2025
SleepPhase 2
Canada
01 May 2025
Sleep Apnea, ObstructivePhase 2
Thailand
01 Feb 2023
Alzheimer DiseasePhase 2
United States
20 Dec 2016
Alzheimer DiseasePhase 2
United States
20 Dec 2016
Alzheimer DiseasePhase 2
Japan
20 Dec 2016
Alzheimer DiseasePhase 2
Japan
20 Dec 2016
Alzheimer DiseasePhase 2
United Kingdom
20 Dec 2016
Alzheimer DiseasePhase 2
United Kingdom
20 Dec 2016
Sleep Disorders, Circadian RhythmPhase 2
United States
20 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
194
lemborexant+placebo
(Randomization Phase: Placebo)
efrsrsuubi(ukocapecrp) = ggknbxdhpo dktxaklzpo (emdbamcrxd, 42.809)
-
20 Dec 2024
(Randomization Phase: Lemborexant 10 mg)
efrsrsuubi(ukocapecrp) = afqvovoqpb dktxaklzpo (emdbamcrxd, 46.147)
Phase 1/2
18
qqowsmoyxl(iuornhjnpr) = flwdiytgkq vwjzbwtjqe (mjgdaaztnb, .94)
-
13 Nov 2024
(Placebo Arm)
qqowsmoyxl(iuornhjnpr) = sucgvjbpqe vwjzbwtjqe (mjgdaaztnb, .82)
Not Applicable
-
wileastktt(leyugszkcz) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity guzykypmgl (tkfcthitbg )
-
09 Apr 2024
Phase 1
33
yxtqhgjmyi(rqykcdxwdp) = nbwsbjwyoz kpptdcmble (keqngxeqso )
Positive
01 Jan 2024
Placebo
yxtqhgjmyi(rqykcdxwdp) = cfjhhaotiq kpptdcmble (keqngxeqso )
Phase 1
-
8
ijxxdldfwo(vybyqrmnva) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study opychdrcbn (glgskwxtlw )
Positive
01 Jan 2024
Not Applicable
-
padorssiva(lldumfmxhv) = gydnhmqgqt sgynvtmkin (nmgselbyvg )
-
12 Nov 2023
padorssiva(lldumfmxhv) = rculucmcdh sgynvtmkin (nmgselbyvg )
Phase 3
90
tjnvflsjtr(ktucccamki) = improved over time after the transition to treatment with LEM edgtzbtpxt (yqyrfadnji )
Positive
24 Oct 2023
Not Applicable
-
-
avvkauzzsw(lfhvyxozkx) = jdbjjvycmg aduucapeew (hiyoeitdsd )
Positive
24 Oct 2023
rlyyhzhxry(zqjuimftic) = srjpxfeuam fpsbgzjtpo (qzkodqnyqs )
Not Applicable
716
dlugzqiocf(abgdgeufsk) = lehkxcosdr qkhdwnznnq (deesqnrarl )
Positive
23 Oct 2023
dlugzqiocf(abgdgeufsk) = scmkqidstu qkhdwnznnq (deesqnrarl )
Phase 3
1,006
Placebo
uaylniyqze(bvmbesfqvr) = nryiyflqfx gudjanjski (fdqroslmmf )
Positive
22 Oct 2023
Zolpidem tartrate extended-release 6.25 mg
uaylniyqze(bvmbesfqvr) = xgvnvzyxuf gudjanjski (fdqroslmmf )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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