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

Idorsia Pharmaceuticals

Status: Enrolling

Conditions: Insomnia

Treatments: Other: No insomnia medication; Drug: Daridorexant; Drug: Non-orexin receptor antagonist medications for insomnia

Study type: Observational

Funder types: Industry

Identifiers

NCT06498128

ID-078A403

1000000033 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 785 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

785 participants in 3 patient groups

QUIVIQ (Cohort A)

Description:

Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Treatment:

Drug: Daridorexant

Non-orexin receptor antagonist medications for insomnia (Cohort B1)

Description:

Women exposed to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.

Treatment:

Drug: Non-orexin receptor antagonist medications for insomnia

No insomnia medications (Cohort B2)

Description:

Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Treatment:

Other: No insomnia medication