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

Recruitingn/aAges 15 Years - 50 YearsFemaleIdorsia Pharmaceuticals Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Daridorexant
  • Non-orexin receptor antagonist medications for insomnia
  • No insomnia medication
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Where

7 sites
IQVIA US Office
Durham, United States
Jodha Tishon
Toronto, 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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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