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What the FDA labels say about taking them together

Ramelteon and testosterone

Ramelteon's FDA label of April 15, 2026 names testosterone in its warnings and precautions section; the testosterone labels PlainMeds reads (4) do not name ramelteon. The ramelteon label: “… vehicle, after ingesting the drug. Reproductive effects: Include decreased testosterone and increased prolactin levels.”

Check it at the source: the ramelteon FDA label on DailyMed (effective April 15, 2026, Takeda Pharmaceuticals America, Inc.); the testosterone FDA label on DailyMed (effective July 25, 2025, Azurity Pharmaceuticals, Inc.).

What does the ramelteon label say about testosterone?

Ramelteon label, warnings and precautions

Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug. ( 5.4 ) Reproductive effects: Include decreased testosterone and increased prolactin levels.

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

What does the testosterone label say about ramelteon?

Testosterone's label (effective July 25, 2025) and its 3 other brand-application labels do not name ramelteon in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (AZMIRO), Azurity Pharmaceuticals, Inc., effective July 25, 2025 (SPL set 235b5625-570d-3fba-e063-6394a90aa2d1), 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

27Ramelteon generic labelers
33Testosterone generic labelers
RamelteonTestosterone
Labeled forInsomniaBreast cancer
Boxed warningNoNo
Pharmacy cost (NADAC)$0.660 per tablet 8 mg tablet$11.39 per mL 200 mg/mL
Shortage nowA presentation being discontinuedNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?