Wednesday, July 8, 2026

Drug profile · INN

ramelteon

ramelteon (ROZEREM) is a melatonin receptor agonist. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 1
Pipeline programs 33
News articles 0
Drug details — ramelteon
US status
approved
Class
Route
ORAL
Patents
1
Programs
33
Data quality
0.89

Quick answer

ramelteon (ROZEREM) is a melatonin receptor agonist. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ramelteon
Brand ROZEREM
Mechanism Melatonin receptor agonist
Target Melatonin receptor
Route ORAL
Formulation TABLET
Originator Takeda

Mechanism of action

Melatonin receptor agonist

Primary target: Melatonin receptor

Approval history

Authority Status Date
FDA approved
PMDA approved

Pipeline programs

  1. Ramelteon Phase 3 · Takeda · Balance
  2. Ramelteon Phase 3 · Takeda · Sleep Initiation and Maintenance Disorders
  3. Ramelteon Phase 3 · Takeda · Transient Insomnia
  4. Ramelteon SL Phase 3 · Takeda · Bipolar Disorder
  5. Ramelteon SL Phase 3 · Takeda · Acute Depressive Episode
  6. Ramelteon SL (Dose 1) Phase 3 · Takeda · Bipolar Disorder
  7. Ramelteon and Placebo (9 possible combinations total) Phase 3 · Takeda · Chronic Insomnia
  8. rozerem Phase 3 · Takeda · Insomnia

Related & competitor drugs

  1. tasimelteon Nervous system (N05)
  2. agomelatine Nervous system (N06)
  3. melatonin Nervous system (N05)
  1. US 8084630

    Process for the synthesis of ramelteon and its intermediates

    Expires Mon Dec 22 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ramelteon?

ramelteon (ROZEREM) is a melatonin receptor agonist. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ramelteon?

ROZEREM is a marketed brand name for ramelteon. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ramelteon?

ramelteon has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.