QUVIVIQ® Pregnancy Registry
Research type
Research Study
Full title
QUVIVIQ® Pregnancy Registry
IRAS ID
343039
Contact name
Hugh Solomon Selsick
Contact email
Sponsor organisation
Idorsia Pharmaceuticals Deutschland GmbH
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
8 years, 4 months, 30 days
Research summary
QUVIVIQ® Pregnancy Registry will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ (daridorexant) during pregnancy compared to an unexposed comparator control group.
While research is limited, Insomnia and sleep loss in pregnant women may be associated with adverse maternal and fetal outcomes. QUVIVIQ (daridorexant)is a medication for adults with insomnia. In clinical trials, it was found that daridorexant was associated with improvement in sleep onset, sleep maintenance, total reported sleep duration, and daytime functioning when compared to placebo.
The goal of this pregnancy registry is to provide safety information on maternal, fetal, and infant outcomes for women who were exposed to QUVIVIQ prior to conception through their pregnancy. This registry will monitor the health and safety of these women, and their infants will also be monitored for 1 year.
This observational study will collect primary data from pregnant women with insomnia in a standard-of-care setting. In routine care settings, patients are seen regularly by their treating HCPs either for insomnia treatment or for regular assessment after insomnia treatment. Thus, no study specific visits or evaluations are required by this protocol. The data will be provided by the patients and their Healthcare Professionals (HCPs) and the infant’s HCPs.
Planned study duration is approximately 8 years (2025-2033). Study will be conducted in USA, Canada and European countries.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0553
Date of REC Opinion
5 Nov 2025
REC opinion
Further Information Favourable Opinion