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What the FDA labels say about taking them together

Darunavir and zolpidem

Darunavir's FDA label of August 29, 2025 names zolpidem in its drug interactions section; the zolpidem labels PlainMeds reads (4) do not name darunavir. The darunavir label: “Titration is recommended when co-administering PREZISTA/ritonavir with sedatives/hypnotics metabolized by CYP3A and a lower dose of the sedatives/hypnotics should be considered with monitoring for adverse events.”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the zolpidem FDA label on DailyMed (effective August 15, 2022, Viatris Specialty LLC).

What does the darunavir label say about zolpidem?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: metabolized by CYP3A e.g. buspirone, diazepam, estazolam, zolpidem; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ sedatives/hypnotics; Clinical Comment: Titration is recommended when co-administering PREZISTA/ritonavir with sedatives/hypnotics metabolized by CYP3A and a lower dose of the sedatives/hypnotics should be considered with monitoring for adverse events.

Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed

What does the zolpidem label say about darunavir?

Zolpidem's label (effective August 15, 2022) and its 3 other brand-application labels do not name darunavir in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Edluar), Viatris Specialty LLC, effective August 15, 2022 (SPL set a32884d0-85b5-11de-8a39-0800200c9a66), 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

13Darunavir generic labelers
39Zolpidem generic labelers
DarunavirZolpidem
Labeled forHIVInsomnia
Boxed warningNoYes
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$0.0344 per tablet 5 mg tablet
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?