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)
Major congenital malformations classified according to MACDP — Start of pregnancy up to 1 year of infant age Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
Trial sites (7)
Facility
City
Region
Status
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
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.
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