This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Diagnosis of insomnia disorder prior to pregnancy.
Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
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.
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.
Diagnosis of insomnia disorder prior to pregnancy.
Pregnancy has ended.
Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Idorsia Pharmaceuticals Ltd.
Lead sponsor
IQVIA Pty Ltd
Collaborator