Ramelteon
Melatonin Receptor Agonist — NERVOUS SYSTEM
Also known as: rozerem, TAK-375
Data last refreshed: (DrugCentral release 2024-11-01)
Key facts
Ramelteon is an ofp drug in the Melatonin Receptor Agonist class catalogued in DrugCentral. It was first approved by the FDA in 2005. Its mechanism of action is classified as Melatonin Receptor Agonists. DrugCentral lists 3 molecular targets, including MTNR1A, MTNR1B and SIGMAR1. Recorded indications include Initial insomnia.
- Approval status: ofp (first approved 2005 by the FDA).
- Drug class: Melatonin Receptor Agonist.
- Mechanism of action: Melatonin Receptor Agonists.
- Molecular targets: MTNR1A, MTNR1B and SIGMAR1 (3 listed in DrugCentral).
- Indications: Initial insomnia.
- ATC code: N05CH02 (Melatonin receptor agonists).
- Molecular formula: C16H21NO2; molecular weight 259.35 g/mol.
Indications & contraindications
Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).
Indications (1)
- Initial insomnia
Contraindications (8)
- Alcoholism
- Depressive disorder
- Disease of liver
- Hepatic failure
- Hyperprolactinemia
- Sleep apnea
- Sleep automatism
- Suicidal thoughts
Mechanism & targets
| Mechanism of action (MoA) | Melatonin Receptor Agonists |
|---|---|
| Established pharmacologic class | Melatonin Receptor Agonist |
Molecular targets (3)
| Target | Gene | Action | Activity |
|---|---|---|---|
| Melatonin receptor type 1A | MTNR1A | agonist | Ki 10.90 |
| Melatonin receptor type 1B | MTNR1B | agonist | Ki 10.39 |
| Sigma non-opioid intracellular receptor 1 | SIGMAR1 | unknown | Ki 5.05 |
Regulatory approvals (1)
| Date | Agency | Marketed as | Applicant | Orphan |
|---|---|---|---|---|
| 2005-07-22 | FDA | — | TAKEDA PHARMS USA |
ATC classification
| ATC code | Therapeutic hierarchy |
|---|---|
N05CH02 | NERVOUS SYSTEM › PSYCHOLEPTICS › HYPNOTICS AND SEDATIVES › Melatonin receptor agonists |
Reported adverse-event signals
Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.
| MedDRA term | LLR |
|---|---|
| Abnormal dreams | 216.0 |
| Nightmare | 196.3 |
| Initial insomnia | 196.3 |
| Somnolence | 195.7 |
| Middle insomnia | 169.3 |
| Pneumonia aspiration | 112.5 |
| Hepatic function abnormal | 109.2 |
| Hangover | 101.8 |
| Poor quality sleep | 99.9 |
| Altered state of consciousness | 94.6 |
| Product dispensing error | 78.0 |
| Restlessness | 76.2 |
Chemical structure
| Molecular formula | C16H21NO2 |
|---|---|
| Molecular weight | 259.35 g/mol |
| CAS number | 196597-26-9 |
| InChIKey | YLXDSYKOBKBWJQ-LBPRGKRZSA-N |
| PubChem CID | 208902 |
Frequently asked questions
Answers are generated from the structured data on this page, not written by hand.
What is Ramelteon used for?
DrugCentral lists the following indications for Ramelteon: Initial insomnia.
How does Ramelteon work?
Ramelteon is classified as Melatonin Receptor Agonists; its molecular targets in DrugCentral include MTNR1A (agonist), MTNR1B (agonist) and SIGMAR1.
When was Ramelteon first approved?
Ramelteon was first approved by the FDA in 2005.
What drug class does Ramelteon belong to?
Ramelteon is in the Melatonin Receptor Agonist class.
What is the chemical formula of Ramelteon?
Ramelteon has the molecular formula C16H21NO2 and a molecular weight of 259.35 g/mol.
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Sources
- DrugCentral drug card 2355 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
- ChEMBL CHEMBL1218 — compound record and bioactivity
- PubChem CID 208902 — chemical identifiers
- DrugBank DB00980 — drug record
- FDA UNII 901AS54I69 — substance identity
- DailyMed: FDA labels for Ramelteon — current prescribing information (label search)
- UniProt P48039 (MTNR1A) — target protein
- UniProt P49286 (MTNR1B) — target protein
- UniProt Q99720 (SIGMAR1) — target protein
- FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
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