Ramelteon is a melatonin receptor agonist indicated for the treatment of insomnia characterized by difficulty with sleep onset. It is available as tablets for oral use. MedsAcross supplies Ramelteon for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ROZEREM ® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly).
Source: US FDA prescribing information
Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT 1 and MT 2 receptors and relative selectivity over the MT 3 receptor. The activity of ramelteon at the MT 1 and MT 2 receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine, and opiates. Ramelteon also does not interfere with the activity of a number of selected enzymes in a standard panel.
Source: US FDA prescribing information
Adult dose: 8 mg taken within 30 minutes of going to bed. Should not be taken with or immediately after a high-fat meal. Total daily dose should not exceed 8 mg.
Source: US FDA prescribing information
Patients who develop angioedema after treatment with ROZEREM should not be rechallenged with the drug. Patients should not take ROZEREM in conjunction with fluvoxamine. History of angioedema while taking ROZEREM. Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination.
Source: US FDA prescribing information
Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. Need to evaluate for comorbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment. Abnormal thinking, behavioral changes, complex behaviors: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioral changes. Depression: Worsening of depression or suicidal thinking may occur. CNS effects: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug. Reproductive effects: Include decreased testosterone and increased prolactin levels. Effect on reproductive axis in developing humans is unknown. Patients with severe sleep apnea: ROZEREM is not recommended for use in this population.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections: Severe anaphylactic and anaphylactoid reactions Abnormal thinking, behavior changes, and complex behaviors CNS effects Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.
Source: US FDA prescribing information
Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon, administer with caution. Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon, administer with caution. Donepezil: Increases systemic exposure of ramelteon, patients should be closely monitored when ramelteon is coadministered with donepezil. Doxepin: Increases systemic exposure of ramelteon, patients should be closely monitored when ramelteon is coadministered with doxepin. Alcohol: Causes additive psychomotor impairment, should not be used in combination.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Keep container tightly closed and protected from moisture and humidity.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Ramelteon, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ramelteon 8 mg tabletOralGeneric name | — | US FDA | Available on request |
| Rozerem 8 mg tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 22 July 2005 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Ramelteon in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Ramelteon and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ramelteon, including Rozerem.
Yes. The US FDA first approved Ramelteon on 22 July 2005, according to Drugs@FDA.
No listed presentation of Ramelteon is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ramelteon is classified under ATC code N05CH02 (Ramelteon).
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