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

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.