Fluvoxamine and Ramelteon interaction

Fluvoxamine and Ramelteon: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Fluvoxamine (fluvoxamine maleate) label · effective 2026-04-23

Major

Ramelteon: Should not be used in combination with fluvoxamine ( 5.8 ).

Warnings and precautionsnames RamelteonView label on DailyMed
Major

Ramelteon should not be used in combination with fluvoxamine.

Warnings and precautionsnames RamelteonView label on DailyMed
Moderate

Ramelteon: When fluvoxamine 100 mg twice daily was administered for 3 days prior to single-dose coadministration of ramelteon 16 mg and fluvoxamine, the AUC for ramelteon increased approximately 190-fold and the C max increased approximately 70-fold compared to ramelteon administered alone.

Warnings and precautionsnames RamelteonView label on DailyMed
Moderate

Ramelteon: See Warnings and Precautions ( 5.8 ) .

Drug interactionsnames RamelteonView label on DailyMed

From the Ramelteon (Rozerem) label · effective 2026-04-15

Major

Patients should not take ROZEREM in conjunction with fluvoxamine [see Drug Interactions (7) ] .

Contraindicationsnames FluvoxamineView label on DailyMed
Major

ROZEREM should not be used in combination with fluvoxamine [see Contraindications (4) , Clinical Pharmacology (12.5) ] .

Drug interactionsnames FluvoxamineView label on DailyMed
Major

Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination.

Contraindicationsby drug classView label on DailyMed
Moderate

Effects of Other Drugs on ROZEREM 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 ROZEREM, compared to ROZEREM administered alone.

Drug interactionsby drug classView label on DailyMed
Moderate

ROZEREM should be administered with caution to patients taking less strong CYP1A2 inhibitors.

Drug interactionsby drug classView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.