Daridorexant and Ketoconazole interaction

Daridorexant and Ketoconazole: 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 Daridorexant (QUVIVIQ) label · effective 2026-02-26

Major

Strong CYP3A4 inhibitors: Avoid concomitant use.

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Major

Concomitant use of QUVIVIQ with a strong inhibitor of CYP3A4 is not recommended [see Dosage and Administration (2.2) ] .

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Moderate

Moderate CYP3A4 inhibitors: Maximum recommended dose is 25 mg.

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Moderate

Table 2 Effects of Other Drugs on QUVIVIQ Strong or Moderate CYP3A4 Inhibitors Clinical Implications: Concomitant use with a strong or moderate CYP3A4 inhibitor increases exposure to daridorexant [see Clinical Pharmacology (12.3) ] , which may increase the risk of QUVIVIQ adverse reactions.

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Moderate

Prevention or Management: The recommended dose of QUVIVIQ is 25 mg when used with a moderate CYP3A4 inhibitor [see Dosage and Administration (2.2) ] .

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From the Ketoconazole label · effective 2026-07-07

Major

This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents.

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Major

…methadone when coadministered with ketoconazole tablets may increase the risk of serious cardiovascular events including QT prolongation and torsade de pointes, or respiratory or CNS depression [See CONTRAINDICATIONS .] Fentanyl: The potential increase in plasma concentrations of fentanyl when coadministered with ketoconazole tablets may increase the risk of…

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Moderate

Antipsychotics, Anxiolytics and Hypnotics Lurasidone, alprazolam, oral midazolam, pimozide, triazolam aripiprazole, buspirone, haloperidol, midazolam IV, quetiapine, ramelteon, risperidone The increase in plasma concentrations of lurasidone when coadministered with ketoconazole tablets may increase the risk of serious side effects (See CONTRAINDICATIONS ).

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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.