This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

ID-078A404

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
15 to 50 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy

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.