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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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Target
Variants
Financial
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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 (discontinued: Ramelteon)
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
ramelteonANDA2026-09-01
rozeremNew Drug Application2026-04-15
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
80 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 disordersD007319—F51.01341713441
DeliriumD003693—R41.0—1—517
Bipolar disorderD001714EFO_0000289F30.9——41—5
Sleep wake disordersD012893—G47—2—114
ParasomniasD020447—G47.5—11114
Chronobiology disordersD021081—————213
DepressionD003863—F33.9——21—3
Depressive disorderD003866EFO_1002014F32.A——21—3
SchizophreniaD012559EFO_0000692F20———2—2
Sleep deprivationD012892—F51.12———112
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obstructive sleep apneaD020181EFO_0003918G47.33—11—13
Sleep apnea syndromesD012891EFO_0003877G47.3—11—13
ApneaD001049—R06.81—11——2
AsthmaD001249EFO_0000270J45——1——1
Gastroesophageal refluxD005764EFO_0003948K21——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1—1———1
Lung injuryD055370—S27.30—1———1
Tobacco use disorderD014029—F17—1———1
Delayed emergence from anesthesiaD055191———1———1
Emergence deliriumD000071257———1———1
Cognitive dysfunctionD060825—G31.84—1———1
Cognition disordersD003072———1———1
Neurocognitive disordersD019965—F09—1———1
Migraine without auraD020326EFO_0005296G43.0—1———1
Migraine with auraD020325EFO_0005295G43.1—1———1
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Marijuana abuseD002189EFO_0007191F121————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinsonian disordersD020734—G20.C————11
Healthy volunteers/patients———————11
NeuralgiaD009437EFO_0009430—————11
Panic disorderD016584EFO_0004262F41.0————11
Lewy body diseaseD020961EFO_0006792G31.83————11
DementiaD003704EFO_0003862F03————11
Huntington diseaseD006816Orphanet_399G10————11
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
Image (chem structure or protein)Loading
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 2,367 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,818 adverse events reported
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