Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

NCT06498128 | Recruiting FDA Drug

• 2 other identifiers: ID-078A4031000000033
• Study Type: observational
• Target: 785
• Locations: 7 countries
• Sites: 7

Brief Summary

This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

Conditions

Insomnia

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Major congenital malformations classified according to MACDP

  Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.

  Start of pregnancy up to 1 year of infant age

Secondary Outcomes (18)

• Pregnancy complications - number of participants with pre-eclampsia

  20 weeks gestation until delivery/birth/labor

• Pregnancy complications - number of participants with pregnancy-induced hypertension

  20 weeks gestation until delivery/birth/labor

• Pregnancy complications - number of participants with pre-term labor

  Start of pregnancy up to 37 weeks gestation

• Pregnancy complications - number of participants with gestational diabetes

  Start of pregnancy until delivery/birth/labor

• Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination

  Start of pregnancy until delivery/birth/labor

Study Arms (3)

QUIVIQ (Cohort A)

Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Drug: Daridorexant

Non-orexin receptor antagonist medications for insomnia (Cohort B1)

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.

Drug: Non-orexin receptor antagonist medications for insomnia

No insomnia medications (Cohort B2)

Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Other: No insomnia medication

Interventions

Daridorexant DRUG

Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.

Also known as: QUVIVIQ

QUIVIQ (Cohort A)

Non-orexin receptor antagonist medications for insomnia DRUG

Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.

Non-orexin receptor antagonist medications for insomnia (Cohort B1)

No insomnia medication OTHER

No insomnia medication was administered.

No insomnia medications (Cohort B2)

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with insomnia disorder, monitored in a standard-of-care setting, and pregnant at time of enrollment (prospective pregnancies) will be assigned to a specific cohort according to the insomnia medication received. Women with insomnia disorder for whom the outcome of pregnancy is known prior to enrollment (retrospective pregnancies) will be analyzed in a separate case series.

You may qualify if:

• 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 5 half-lives prior to conception.
• Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
• No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

You may not qualify if:

• Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.
• B) Eligibility criteria for retrospective pregnancies:
• Diagnosis of insomnia disorder prior to pregnancy.
• Pregnancy has ended.
• Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
• Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (7)

IQVIA US Office

Durham, North Carolina, 27703, United States

RECRUITING

Jodha Tishon

Toronto, Ontario, Canada

NOT YET RECRUITING

Hôpital Gui de Chauliac

Montpellier, France

NOT YET RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, Germany

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Italy

NOT YET RECRUITING

Hospital Txagorritxu

Vitoria-Gasteiz, Spain

NOT YET RECRUITING

University College London Hospitals

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Clinical Trials Study Director

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Central Study Contacts

Clinical Trial Information USA

CONTACT

+1 856 661 37 21; idorsiaclinicaltrials@idorsia.com

Clinical Trial Information Europe

CONTACT

+41 58 844 19 77; idorsiaclinicaltrials@idorsia.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 12, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1); DE (1); CA (1); IT (1); FR (1); ES (1)