Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
QUVIVIQ® Pregnancy Registry
Idorsia Pharmaceuticals Ltd.
785 participants
Nov 21, 2024
OBSERVATIONAL
Conditions
Summary
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Eligibility
Inclusion Criteria10
- A) Eligibility criteria for prospective pregnancies:
- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
- One of the following:
- Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
- Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
- No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy has ended.
- Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Exclusion Criteria3
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.
- B) Eligibility criteria for retrospective pregnancies:
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
No insomnia medication was administered.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06498128