What the FDA labels say about taking them together
Fluvoxamine and ramelteon
Fluvoxamine's FDA label of June 27, 2026 names ramelteon in its contraindications section, and ramelteon's label names fluvoxamine too. The fluvoxamine label: “CONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated.”
Check it at the source: the fluvoxamine FDA label on DailyMed (effective June 27, 2026, Zydus Pharmaceuticals USA Inc.); the ramelteon FDA label on DailyMed (effective April 15, 2026, Takeda Pharmaceuticals America, Inc.).
What does the fluvoxamine label say about ramelteon?
Fluvoxamine label, contraindicationsCONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [ 5.4 to 5.8 ] ).
Fluvoxamine label, warnings and precautionsWhen immediate-release fluvoxamine maleate tablets 100 mg twice daily were administered for 3 days prior to single-dose coadministration of ramelteon 16 mg and immediate-release fluvoxamine maleate tablets, the AUC for ramelteon increased approximately 190-fold and the C max increased approximately 70-fold compared to ramelteon administered alone.
Source: FDA drug label (Fluvoxamine Maleate, NDA021519), ANI Pharmaceuticals, Inc., effective August 4, 2025 (SPL set 7ecd83ec-88f5-4f85-9cc2-9068375d8820), via openFDA
Source: FDA drug label (Fluvoxamine maleate extended-release), Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
What does the ramelteon label say about fluvoxamine?
Ramelteon label, contraindicationsPatients should not take ROZEREM in conjunction with fluvoxamine [see Drug Interactions (7) ].
Ramelteon label, drug interactionsDrugs 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.
Source: FDA drug label (Rozerem), Takeda Pharmaceuticals America, Inc., effective April 15, 2026 (SPL set 9de82310-70e8-47b9-b1fc-6c6848b99455), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Fluvoxamine | Ramelteon | |
|---|---|---|
| Labeled for | n/a | Insomnia |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $4.08 per capsule 100 mg capsule | $0.660 per tablet 8 mg tablet |
| Shortage now | No current entry | A presentation being discontinued |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once