Clinical Research Directory

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.