Back to Trials
NCT06498128Recruiting

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

Idorsia Pharmaceuticals Ltd.

Start Date

11/21/2024

Completion Date

3/1/2033

Summary

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

Eligibility Criteria

Age Range: 15 years to 50 years

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.

Interventions

DRUG

Daridorexant

DRUG

Non-orexin receptor antagonist medications for insomnia

OTHER

No insomnia medication

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Insomnia

Locations

IQVIA US Office

Durham, North Carolina 27703

United States

Jodha Tishon

Toronto, Ontario

Canada

Hôpital Gui de Chauliac

Montpellier,

France

Charité - Universitätsmedizin Berlin

Berlin,

Germany

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome,

Italy

Hospital Txagorritxu

Vitoria-Gasteiz,

Spain

University College London Hospitals

London,

United Kingdom