QUVIVIQ® Pregnancy Registry

Idorsia Pharmaceuticals Ltd.

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

Age range: 15–50 years
Sex: Female
Healthy volunteers: No

Detailed 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 pr…

Interventions

Drug
Daridorexant
Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
Drug
Non-orexin receptor antagonist medications for insomnia
Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
Other
No insomnia medication
No insomnia medication was administered.

Locations (7)

IQVIA US Office
Durham, North Carolina
Jodha Tishon
Toronto, Ontario
Hôpital Gui de Chauliac
Montpellier
Charité - Universitätsmedizin Berlin
Berlin
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome
Hospital Txagorritxu
Vitoria-Gasteiz