Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Sponsored by Idorsia Pharmaceuticals Ltd.
About this trial
Last updated a year ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the Participation Requirements?
1. Evidence of a singleton end of pregnancy event during the intake period.
2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of
conception and ends at the end of pregnancy.
3. Date of conception ≥ 42 weeks before the end of the intake period.
4. Age 15 to 50 years at the date of conception.
5. Continuous medical and pharmacy insurance coverage during the period which begins 6
months prior to the date of conception and ends at the end of pregnancy.
6. No dispensing of known or suspected teratogenic medications during the period which
begins 5 half lives of that medication prior to the date of conception and ends at
the end of pregnancy.
7. No exposure to other orexin receptor antagonists during the exposure period, i.e.,
suvorexant, lemborexant, and any orexin receptor antagonists newly approved during
the intake period.