Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

What this study is about

This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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:

✅ You may be able to join if…

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

🚫 You may not be able to join if…

• 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

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

Who to contact

Clinical Trial Information USA · +1 856 661 37 21 · idorsiaclinicaltrials@idorsia.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06498128.