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Drug ReportsRamelteon
Ramelteon
Ramelteon, Rozerem (ramelteon) is a small molecule pharmaceutical. Ramelteon was first approved as Rozerem on 2005-07-22. It is used to treat sleep initiation and maintenance disorders in the USA. The pharmaceutical is active against melatonin receptor type 1A and melatonin receptor type 1B.
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Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Ramelteon, Rozerem
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ramelteon
Tradename
Company
Number
Date
Products
ROZEREMTakedaN-021782 RX2005-07-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ramelteonANDA2025-09-30
rozeremNew Drug Application2025-07-15
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05C: Hypnotics and sedatives
N05CH: Melatonin receptor agonists, hypnotics and sedatives
N05CH02: Ramelteon
HCPCS
No data
Clinical
Clinical Trials
78 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep initiation and maintenance disordersD007319F51.0124158332
Bipolar disorderD001714EFO_0000289F30.9415
Sleep wake disordersD012893G47213
DepressionD003863F33.9213
Depressive disorderD003866EFO_1002014F32.A213
Migraine disordersD008881EFO_0003821G43112
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9112
Lung diseasesD008171EFO_0003818J98.4112
Obstructive lung diseasesD008173112
Major depressive disorderD003865EFO_0003761F22112
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ParasomniasD020447G47.5112
Obstructive sleep apneaD020181EFO_0003918G47.33112
Sleep apnea syndromesD012891EFO_0003877G47.3112
ApneaD001049R06.81112
AsthmaD001249EFO_0000270J4511
DyssomniasD02092011
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinsonian disordersD020734G20.C11
Rem sleep behavior disorderD020187EFO_0007462G47.5211
Mental disordersD001523EFO_0000677F91.911
Healthy volunteers/patients11
NeuralgiaD009437EFO_000943011
Panic disorderD016584EFO_0004262F41.011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRamelteon
INNramelteon
Description
N-[2-[(8S)-2,6,7,8-tetrahydro-1H-cyclopenta[e]benzofuran-8-yl]ethyl]propanamide is a member of indanes.
Classification
Small molecule
Drug classselective melatonin receptor agonist
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Structure (InChI/SMILES or Protein Sequence)
CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Identifiers
PDB
CAS-ID196597-26-9
RxCUI
ChEMBL IDCHEMBL1218
ChEBI ID
PubChem CID208902
DrugBankDB00980
UNII ID901AS54I69 (ChemIDplus, GSRS)
Target
Agency Approved
MTNR1B
MTNR1B
Organism
Homo sapiens
Gene name
MTNR1B
Gene synonyms
NCBI Gene ID
Protein name
melatonin receptor type 1B
Protein synonyms
mel1b receptor, melatonin receptor MEL1B
Uniprot ID
Mouse ortholog
Mtnr1b (244701)
melatonin receptor type 1B (Q8CIQ6)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Ramelteon
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,980 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,778 adverse events reported
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