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What the FDA labels say about taking them together

Eszopiclone and ketoconazole

Eszopiclone's FDA label of January 30, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name eszopiclone. The eszopiclone label: “Ketoconazole: Combination use increases exposure and effect of eszopiclone.”

Check it at the source: the eszopiclone FDA label on DailyMed (effective January 30, 2026, Glenmark Pharmaceuticals Inc. USA); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the eszopiclone label say about ketoconazole?

Eszopiclone label, drug interactions

Ketoconazole: Combination use increases exposure and effect of eszopiclone.

Eszopiclone label, warnings and precautions

The dose of eszopiclone should be reduced in patients who are administered potent inhibitors of CYP3A4, such as ketoconazole, while taking eszopiclone.

Lunesta label (Waylis Therapeutics LLC, January 8, 2025), drug interactions

Use with ethanol causes additive psychomotor impairment ( 7.1 ) Rifampicin: Combination use may decrease exposure and effects of LUNESTA ( 7.2 ) Ketoconazole: Combination use increases exposure and effect of LUNESTA.

Source: FDA drug label (Lunesta, NDA021476), Waylis Therapeutics LLC, effective January 8, 2025 (SPL set 3821f4b7-a3c8-4920-ba80-18aa96532c09), via openFDA

Source: FDA drug label (Eszopiclone), Glenmark Pharmaceuticals Inc. USA, effective January 30, 2026 (SPL set 584dc66c-063a-4552-a056-74b811e2bc80), via openFDA; the full label on DailyMed

What does the ketoconazole label say about eszopiclone?

Ketoconazole's label (effective January 28, 2026) does not name eszopiclone in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), 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

27Eszopiclone generic labelers
30Ketoconazole generic labelers
EszopicloneKetoconazole
Labeled forInsomniaFungal infections
Boxed warningYesNo
Pharmacy cost (NADAC)$0.0993 per tablet 1 mg tablet$0.249 per gram 2% cream
Shortage nowNo current entryNo 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?