Ramelteon is an orally active hypnotic chemically designated as ( S )- N -[2-(1,6,7,8-tetrahydro-2 H -indeno-[5,4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S )-enantiomer, with an empirical formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure: Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. ramelteon-structure-jpg

What kind of drug is ramelteon?

The FDA classifies ramelteon as a melatonin receptor agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take ramelteon with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ramelteon against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is ramelteon sold under?

We track 2 ramelteon-containing products in the U.S.: Ramelteon and Rozerem. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does ramelteon come in?

Across the brands we track, ramelteon is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic ramelteon?

Yes. Our catalog lists 1 generic ramelteon product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Ramelteon: uses, dosing, side effects & brands

Ramelteon is a melatonin receptor agonist sold in the U.S. under 2 brand and generic names, for sleep initiation and maintenance disorders. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Drug class: Melatonin Receptor Agonist
Treats: Sleep Initiation and Maintenance Disorders
Available as: Tablet
Sold as: 2 products — Ramelteon and Rozerem
Prescription?: Prescription only
Generic available?: Yes
Typical price: about $21 for a 30-count supply

How ramelteon is dosed

From the FDA label for Ramelteon (application ANDA213186). Other ramelteon products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Dosage in Adults The recommended dose of ramelteon tablets is 8 mg taken within 30 minutes of going to bed. It is recommended that ramelteon tablets not be taken with or immediately after a high-fat meal. The total ramelteon tablets dose should not exceed 8 mg per day. • Adult dose: 8 mg taken within 30 minutes of going to bed. (2.1) • Should not be taken with or immediately after a high-fat meal. ( 2.1 ) • Total daily dose should not exceed 8 mg. ( 2.1 ) 2.1 Dosage in Adults The recommended dose of ramelteon tablets is 8 mg taken within 30 minutes of going to bed. It is recommended that ramelteon tablets not be taken with or immediately after a high-fat meal. The total ramelteon tablets dose should not exceed 8 mg per day. 2.2 Dosing in Patients with Hepatic Impairment Ramelteon tablets are not recommended in patients with severe hepatic impairment. Ramelteon tablets should be used with caution in patients with moderate hepatic impairment [see Warnings and Precaution ( 5.6 ), Clinical Pharmacology ( 12.4 )]. 2.3 Administration with Other Medications Ramelteon tablets should not be used in combination with fluvoxamine. Ramelteon tablets should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions ( 7 ), Clinical Pharmacology ( 12.5 )]. 2.1 Dosage in Adults The recommended dose of ramelteon tablets is 8 mg taken within 30 minutes of going…

Ramelteon side effects

The following serious adverse reactions are discussed in greater detail in other sections: • Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.1) ] • Abnormal thinking, behavior changes, and complex behaviors [see Warnings and Precautions (5.3) ] • CNS effects [see Warnings and Precautions (5.4) ] • Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment The data described in this section reflect exposure to ramelteon tablets in 5,373 subjects, including 722 exposed for six months or longer and 448 subjects for one year. Six percent of the 5,373 individual subjects exposed to Ramelteon tablets in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2,279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ramelteon tablets were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less. Ramelteon Tablets Most Commonly Observed Adverse Events Table 1 displays the incidence…

Every ramelteon product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Ramelteon products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Ramelteon	72/100	Prescription	Tablet	Generic	$21	View →
2	Rozerem	Not yet rated	Prescription	Tablet	Generic	$21

What ramelteon pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Ramelteon pill imprints
Imprint	Strength	Colour	Shape	Maker
RM	8 mg	yellow	round	—
196;I	8 mg	yellow	round	—
RM	8 mg	yellow	round	—
196;I	8 mg	yellow	round	—
TAK;RAM;8	8 mg	orange	round	—

Frequently asked questions

What is ramelteon?: Ramelteon is an orally active hypnotic chemically designated as ( S )- N -[2-(1,6,7,8-tetrahydro-2 H -indeno-[5,4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S )-enantiomer, with an empirical formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure: Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. ramelteon-structure-jpg
What kind of drug is ramelteon?: The FDA classifies ramelteon as a melatonin receptor agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ramelteon with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ramelteon against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is ramelteon sold under?: We track 2 ramelteon-containing products in the U.S.: Ramelteon and Rozerem. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does ramelteon come in?: Across the brands we track, ramelteon is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Ramelteon drug interactions

Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. (7.1) • Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution. (7.1) • Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon; administer with caution. (7.1) • Donepezil: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with donepezil. (7.1) • Doxepin: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin. (7.1) • Alcohol: Causes additive psychomotor impairment; should not be used in combination. (7.2) 7.1 Effects of Other Drugs on Ramelteon Tablets Fluvoxamine (strong CYP1A2 inhibitor): AUC 0-inf for ramelteon increased approximately 190-fold, and the C max increased approximately 70-fold upon coadministration of fluvoxamine and ramelteon, compared to ramelteon administered alone. Ramelteon tablets should not be used in combination with fluvoxamine [see Contraindications (4), Clinical Pharmacology (12.5) ]. Other less strong CYP1A2 inhibitors have not been adequately studied. Ramelteon tablets should be administered with caution to patients taking less strong CYP1A2 inhibitors. Rifampin (strong CYP enzyme inducer): Administration of multiple doses of rifampin resulted in a…