Wechselwirkungen · Quviviq
QUVIVIQ 25 mg film-coated tablets QUVIVIQ 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6
HOS-148260 · Präparat HOS-099866
Substrates of CYP3A4 In a clinical study conducted in healthy subjects receiving daridorexant and midazolam, a sensitive CYP3A4 substrate, daridorexant at a dose of 25 mg did not affect the PK of midazolam, indicating an absence of CYP3A4 induction or inhibition at this dose. In a clinical study conducted in healthy subjects receiving 50 mg daridorexant and midazolam, exposure (AUC) to midazolam increased by 42%, indicating a mild CYP3A4 inhibition. Simultaneous administration of 50 mg QUVIVIQ with sensitive CYP3A4 substrates with a narrow therapeutic index (e.g., high-dose simvastatin, tacrolimus) should be handled with caution. In the same study, daridorexant 50 mg administered for 7 days did not induce CYP3A4, therefore contraceptives can be co-administered with QUVIVIQ.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): simvastatin (HOS-086158) tacrolimus (HOS-085202) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-03-12T16:40:00Z · SHA-256 5355155af856aafb53e689e2fbc2ec06efe5415b8ac06dc050f95e8259efdb63 · Passage f68d59e78bb4a0b923f9700949a3ea787b4bbbdf8e322880ab21781db295caf0 · Zeichen 1799–2583 im Abschnitt