Phase
Condition
Insomnia
Treatment
Daridorexant
No insomnia medication
Non-orexin receptor antagonist medications for insomnia
Clinical Study ID
Ages 15-50 Female
Study Summary
Eligibility Criteria
Inclusion
A) Eligibility criteria for prospective pregnancies:
Inclusion Criteria:
Diagnosis of insomnia disorder prior to pregnancy.
Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth)is not known.
One of the following:
Exposure to QUVIVIQ at any time during the current pregnancy or within 5half-lives prior to conception.
Exposure to other, non-orexin receptor antagonist medications for insomniaduring pregnancy or within 5 half-lives of the respective insomnia medicationprior to conception.
No exposure to any insomnia medication during pregnancy and within 5 half-livesof any insomnia medication taken prior to conception.
Exclusion
Exclusion Criteria:
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approvedduring the study period, or any orexin receptor antagonist in pre-market clinicalstudies - during the current pregnancy or within 5 half-lives of the respectivemedication prior to conception.
B) Eligibility criteria for retrospective pregnancies:
Inclusion criteria:
Diagnosis of insomnia disorder prior to pregnancy.
Pregnancy has ended.
Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Exclusion criteria:
- Exposure to any orexin receptor antagonist other than QUVIVIQ - includingsuvorexant, lemborexant, any orexin receptor antagonist newly approved during thestudy period, or any orexin receptor antagonist in pre-market clinical studies -during pregnancy or within 5 half-lives of the respective medication prior toconception.
Study Design
Connect with a study center
Jodha Tishon
Toronto, Ontario
CanadaSite Not Available
Hôpital Gui de Chauliac
Montpellier,
FranceSite Not Available
Charité - Universitätsmedizin Berlin
Berlin,
GermanySite Not Available
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome,
ItalySite Not Available
Hospital Txagorritxu
Vitoria,
SpainSite Not Available
University College London Hospitals
London,
United KingdomSite Not Available
IQVIA
Boston, Massachusetts 02210
United StatesSite Not Available
IQVIA US Office
Durham, North Carolina 27703
United StatesActive - Recruiting
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