Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Reason given: The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)
Key facts
- Where
- Durham, United StatesSee the site
Where in United States
- IQVIA US OfficeDurham, United StatesNo longer taking part
Trial details
- Who runs it
- Idorsia Pharmaceuticals Ltd.
- Trial code
- NCT06498128
- Record updated
- 29 October 2026
- Original description
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.Read full original descriptionShow less
QUVIVIQ® Pregnancy Registry
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Inclusion: 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: 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; 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; Eligibility criteria for retrospective pregnancies:.
Eligibility criteria for prospective pregnancies:.