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Clinical Trials in the UK / NCT06498128
Recruiting Observational

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

NCT06498128 · tracked via the Priya Life Science UK tracker
Sponsor
Idorsia Pharmaceuticals Ltd.
Phase
Observational
Started
2024-11-21
Last updated
2025-12-02

Condition(s) studied

Insomnia

Investigational drug(s) / intervention(s)

DaridorexantNon-orexin receptor antagonist medications for insomniaNo insomnia medication

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.

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.

No insomnia medication: No insomnia medication was administered.

Study 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

Sex
FEMALE
Min age
15 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
IQVIA US Office Durham North Carolina Recruiting
Jodha Tishon Toronto Ontario Not Yet Recruiting
Hôpital Gui de Chauliac Montpellier France Not Yet Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Not Yet Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Rome Italy Not Yet Recruiting
Hospital Txagorritxu Vitoria-Gasteiz Spain Not Yet Recruiting
University College London Hospitals London United Kingdom Not Yet Recruiting

More Idorsia Pharmaceuticals Ltd. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06498128 on ClinicalTrials.gov ↗ ← All trials in the UK