Darunavir and Midazolam Interaction

Drug interaction information between Darunavir and Midazolam.

Darunavir and Midazolam have a documented major interaction in FDA labeling.

FDA drug labeling documents a major-severity interaction between Darunavir and Midazolam. This page displays the available source-record category and label text. The category is not an individual risk estimate or medication-combination direction.

Drug A

Darunavir

HIV Protease Inhibitor

Drug B

Midazolam

Benzodiazepine

How They Interact

Darunavir blocks the enzyme that breaks down midazolam, causing the sedative to build up in your body. This can lead to dangerously deep sleep or breathing problems.

FDA Label Information

Sedatives/hypnotics: orally administered midazolam, triazolam ↑ midazolam ↑ triazolam Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression. Triazolam and orally administered midazolam are extensively metabolized by CYP3A. Co-administration of triazolam or orally administered midazolam with darunavir may cause large increases in the concentrations of these benzodiazepines.

Frequently Asked Questions

What SPL severity band is on file for Darunavir + Midazolam?

Compiled FDA labeling labels this pair major. That is a source-record field, not an individual medication-combination decision.

Which drug in this pair has the larger labeled-interaction portfolio?

Darunavir has 101 labeled pairs on file vs Midazolam's 39. In the major band specifically: Darunavir has 15 (also Lovastatin, Sildenafil, Lurasidone, Pimozide); Midazolam has 3 (also Itraconazole, Nirmatrelvir/Ritonavir).

What mechanism field is on file for Darunavir and Midazolam?

Darunavir blocks the enzyme that breaks down midazolam, causing the sedative to build up in your body. This can lead to dangerously deep sleep or breathing problems.

Darunavir carries more major-labeled pairs than Midazolam

SPL source-record counts only. This page's band is major · classes on file: Darunavir (HIV Protease Inhibitor); Midazolam (Benzodiazepine).

Darunavir has 15 major-labeled pairs vs Midazolam's 3.

Darunavir

15 major · 16 moderate · 70 minor · 101 total

Midazolam

3 major · 9 moderate · 27 minor · 39 total

Sources: FDA Drug Labels (SPL) via openFDA (2026). This is for informational purposes only and is not medical advice. This registry does not provide individual medication-combination directions.