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Ramelteon

Melatonin Receptor Agonist — NERVOUS SYSTEM

Also known as: rozerem, TAK-375

OfpFDA approvedATC N05CH02

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 classMelatonin Receptor Agonist

Molecular targets (3)

TargetGeneActionActivity
Melatonin receptor type 1AMTNR1AagonistKi 10.90
Melatonin receptor type 1BMTNR1BagonistKi 10.39
Sigma non-opioid intracellular receptor 1SIGMAR1unknownKi 5.05

Regulatory approvals (1)

DateAgencyMarketed asApplicantOrphan
2005-07-22FDA—TAKEDA PHARMS USA

ATC classification

ATC codeTherapeutic hierarchy
N05CH02NERVOUS 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 termLLR
Abnormal dreams216.0
Nightmare196.3
Initial insomnia196.3
Somnolence195.7
Middle insomnia169.3
Pneumonia aspiration112.5
Hepatic function abnormal109.2
Hangover101.8
Poor quality sleep99.9
Altered state of consciousness94.6
Product dispensing error78.0
Restlessness76.2

Chemical structure

Molecular formulaC16H21NO2
Molecular weight259.35 g/mol
CAS number196597-26-9
InChIKeyYLXDSYKOBKBWJQ-LBPRGKRZSA-N
PubChem CID208902
CCC(=O)NCC[C@@H]1CCC2=C1C1=C(OCC1)C=C2

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.

Browse: all drugs starting with R · drug guides by category · protein targets A–Z.

Sources

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For research and educational use only — not medical advice. This page is compiled automatically from public databases. It is not written or reviewed by a clinician. Do not start, stop or change any treatment based on it; consult a qualified healthcare professional. Spotted an error? See our corrections policy or email hello@molforge.ai.

Quick facts

StatusOFP
First approval2005-07-22
AgencyFDA
Targets3
Indications1
FormulaC16H21NO2
DrugCentral ID2355
Interactive profile