Collecting information on pregnancy outcomes for women exposed to QUVIVIQ

QUVIVIQ® Pregnancy Registry

This study is trying to see how using QUVIVIQ during pregnancy affects the health of mothers and their babies compared to women who didn't use it.

Quick facts

• Study type: Observational
• Enrollment: 785 (estimated)
• Ages: 15 Years to 50 Years
• Sex: Female
• Sponsor: Idorsia Pharmaceuticals Ltd. (Industry-sponsored)
• Locations: 7 sites (Durham, North Carolina and 6 other locations)
• Trial ID: NCT06498128 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on pregnancy, neonatal, and infant outcomes in women who have been exposed to QUVIVIQ during pregnancy compared to those who have not been exposed. It will include women diagnosed with insomnia prior to pregnancy and will track their pregnancy outcomes, including live births and pregnancy losses. The study will also consider women who have used other insomnia medications or none at all during their pregnancy. The goal is to better understand the effects of QUVIVIQ on pregnancy and infant health.

Who should consider this trial

Good fit: Ideal candidates are pregnant women with a diagnosis of insomnia who have been exposed to QUVIVIQ or other insomnia medications.

Not a fit: Patients who are not pregnant or who have not been diagnosed with insomnia prior to pregnancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effects of QUVIVIQ on pregnant women and their infants.

How similar studies have performed: While there may be studies on insomnia medications during pregnancy, this specific focus on QUVIVIQ is relatively novel and untested.

Eligibility criteria

A) Eligibility criteria for prospective pregnancies:

Inclusion Criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
3. One of the following:

   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
   2. 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.
   3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Exclusion Criteria:

* 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:

Inclusion criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy has ended.
3. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Exclusion criteria:

* 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.

Where this trial is running

Durham, North Carolina and 6 other locations

• IQVIA US Office — Durham, North Carolina, United States (Recruiting)
• Jodha Tishon — Toronto, Ontario, Canada (Not_yet_recruiting)
• Hôpital Gui de Chauliac — Montpellier, France (Not_yet_recruiting)
• Charité - Universitätsmedizin Berlin — Berlin, Germany (Not_yet_recruiting)
• Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome, Italy (Not_yet_recruiting)
• Hospital Txagorritxu — Vitoria-Gasteiz, Spain (Not_yet_recruiting)
• University College London Hospitals — London, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: Clinical Trial Information USA

Conditions Insomnia; Pregnancy