QUVIVIQ for Insomnia During Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how taking QUVIVIQ, a medication for insomnia, affects pregnancy and the baby's health compared to not taking the medication. It includes different groups: women who took QUVIVIQ, women who took other insomnia medications, and women who didn't take any insomnia medications during pregnancy. The researchers seek women with insomnia who are currently pregnant or have recently been pregnant and fit one of these groups. The goal is to understand the outcomes for both mothers and their babies. As a Phase 4 trial, this research aims to provide insights into how QUVIVIQ benefits more patients and its effects during pregnancy.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any orexin receptor antagonist other than QUVIVIQ during pregnancy or shortly before conception.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that QUVIVIQ, also known as daridorexant, is generally safe for people. The most common side effects include sleepiness and fatigue, which are usually mild. No studies have been conducted on pregnant women, so its effects on them or unborn babies remain unknown. However, animal tests have not indicated any reproductive issues. It is important to consult a healthcare provider to understand the risks and benefits before joining a trial.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to gather important information on how different insomnia treatments might affect pregnancy, newborns, and infants. Unlike other studies that focus solely on the effects of medication on individuals with insomnia, this trial specifically looks at QUVIVIQ®, a new insomnia treatment, in comparison to other medications and no medication at all during pregnancy. This could help identify if QUVIVIQ® has unique effects or safety profiles for pregnant women and their babies. Such insights could be crucial for developing safer insomnia treatments for pregnant women, ensuring better health outcomes for both mothers and their children.
What evidence suggests that this trial's treatments could be effective for pregnancy outcomes?
Research has shown that QUVIVIQ, also known as daridorexant, helps treat insomnia in both younger and older adults by blocking certain parts of the brain that maintain wakefulness, thus facilitating sleep. However, no data exists on its use in pregnant women, leaving the risks of birth defects or miscarriage unknown. This trial will include some women with insomnia who are exposed to QUVIVIQ during pregnancy or shortly before conception. While QUVIVIQ effectively treats insomnia, its safety for pregnant women remains under investigation.23467
Who Is on the Research Team?
Clinical Trials Study Director
Principal Investigator
Idorsia Pharmaceuticals Ltd.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pregnancy Monitoring
Monitoring of pregnancy outcomes, including complications such as hypertension, pre-eclampsia, and gestational diabetes
Infant Follow-up
Monitoring of infant outcomes, including congenital malformations and postnatal growth and development
What Are the Treatments Tested in This Trial?
Interventions
- Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Women exposed to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Idorsia Pharmaceuticals Ltd.
Lead Sponsor
Antonio Olivieri
Idorsia Pharmaceuticals Ltd.
Chief Medical Officer since 2024
Not specified
André C. Muller
Idorsia Pharmaceuticals Ltd.
Chief Executive Officer
Not specified
Iqvia Pty Ltd
Industry Sponsor
Ari Bousbib
Iqvia Pty Ltd
Chief Executive Officer since 2016
MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris
Jeffrey Spaeder
Iqvia Pty Ltd
Chief Medical Officer
MD
Citations
Database Study to Provide Information on Pregnancy and ...
Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs ...
Quviviq - accessdata.fda.gov
There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse ...
QUVIVIQ® (daridorexant) - Insomnia Impact
There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse ...
Study Details | NCT06498128 | Registry to Collect ...
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during ...
Daridorexant in Insomnia Disorder: A Profile of Its Use - PMC
Daridorexant (Quviviq™) is a useful option for the treatment of insomnia disorder, which has shown efficacy in younger and older adults.
QUVIVIQ® (daridorexant) Demonstrated Safety Profile for HCPs
Review QUVIVIQ side effects and safety, including rates of next-day somnolence and fatigue. See info on withdrawal, dependence, and rebound insomnia.
7.
ema.europa.eu
ema.europa.eu/en/documents/product-information/quviviq-epar-product-information_en.pdfQuviviq, INN-daridorexant - European Medicines Agency
There are no data on the use of daridorexant in pregnant women. Animal studies did not indicate harmful effects with respect to reproductive ...
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