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

QUVIVIQ® Pregnancy Registry

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

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: Daridorexant; Drug: Non-orexin receptor antagonist medications for insomnia; Other: No insomnia medication

• Study Type: Observational
• Enrollment (Estimated): 785

Contacts and Locations

• Study Contact: Name: Clinical Trial Information USA; Phone Number: +1 856 661 37 21; Email: idorsiaclinicaltrials@idorsia.com
• Study Contact Backup: Name: Clinical Trial Information Europe; Phone Number: +41 58 844 19 77; Email: idorsiaclinicaltrials@idorsia.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Not yet recruiting
      • Jodha Tishon
• France
  • Montpellier, France
    • Not yet recruiting
    • Hopital Gui de Chauliac
• Germany
  • Berlin, Germany
    • Not yet recruiting
    • Charité - Universitätsmedizin Berlin
• Italy
  • Rome, Italy
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
• Spain
  • Vitoria-Gasteiz, Spain
    • Not yet recruiting
    • Hospital Txagorritxu
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • University College London Hospitals
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Recruiting
      • IQVIA US Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

A) Eligibility criteria for prospective pregnancies:

Inclusion Criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.

3. One of the following:

   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
   2. 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.
   3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Exclusion Criteria:

• 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:

Inclusion criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy has ended.
3. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QUIVIQ (Cohort A); Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.	Drug: Daridorexant; 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.; Other Names: QUVIVIQ
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; 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.
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; No insomnia medication was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy complications - number of participants with pre-eclampsia	The presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with previously normal blood pressure) and proteinuria; or, in the absence of proteinuria, a new onset of hypertension accompanied by one of the following conditions: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms.	20 weeks gestation until delivery/birth/labor
Pregnancy complications - number of participants with pregnancy-induced hypertension	High blood pressure associated with pregnancy, as diagnosed by the treating healthcare provider, i.e., elevated (systolic between 120-129 mmHg and diastolic less than 80 mmHg); Stage 1 hypertension (systolic between 130-139 mmHg or diastolic between 80-89 mmHg); or Stage 2 hypertension (systolic at least 140 mmHg or diastolic at least 90 mmHg).	20 weeks gestation until delivery/birth/labor
Pregnancy complications - number of participants with pre-term labor	Regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy.	Start of pregnancy up to 37 weeks gestation
Pregnancy complications - number of participants with gestational diabetes	Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy.	Start of pregnancy until delivery/birth/labor
Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination	Any induced or voluntary fetal loss during pregnancy.	Start of pregnancy until delivery/birth/labor
Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion	Loss of a fetus due to natural causes at less than 20 weeks of gestation.	Start of pregnancy up to 20 weeks gestation
Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth	Death of a fetus at or after 20 weeks of gestation.	20 weeks gestation up to birth
Pregnancy outcomes - number of participants with pregnancy outcome of live birth	Birth of a surviving neonate.	37 weeks gestation up to 40 weeks gestation
Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth	Live birth prior to 37 weeks gestation: early preterm (< 34 weeks), late preterm (34-36 weeks), and early term (37-38 weeks).	Less than 34 weeks gestation up to 37 weeks gestation
Infant outcomes - number of infants with outcome of minor congenital malformations classified according to MACDP	Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential minor congenital malformations will be evaluated by at least 3, qualified, independent 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
Infant outcomes - infants categorized according to size for gestational age	All live births will be classified using the World Health Organization definition of birth weight, i.e., small (below the 10th percentile), appropriate (between the 10th and 90th percentile), or large (above the 90th percentile) for gestational age.	At birth of infant
Infant outcomes - number of infants with outcome of low birth weight	Birth weight of less than 2500 g; subclassified into very low birth weight (< 1500 g) and moderately low birth weight (1500 g to 2499 g).	At birth of infant
Infant outcomes - number of infants with outcome of infant death	Death of a live-born infant within the first year of life; subclassified as neonatal deaths (≤ 28 days of life) and infant deaths (29 to 365 days of life).	Birth of infant up to 1 year of infant age
Infant outcomes - number of infants with outcome of hospitalization for serious illness	In-patient admissions for treatment of potentially life threatening illnesses among live-born infants within the first year of life.	Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - weight-for-length	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-length percentiles (weight in kilograms, length in centimeters).	Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - head circumference-for-age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific head circumference-for-age percentiles (head circumference in centimeters, age in months and years).	Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - length-for-age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific length-for-age percentiles (length in centimeters, age in months and years).	Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - weight-for-age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-age percentiles (weight in kilograms, age in months and years).	Birth of infant up to 1 year of infant age

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Collaborators: IQVIA Pty Ltd
• Investigators: Study Director: Clinical Trials Study Director, Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; daridorexant
• Other Study ID Numbers: ID-078A403; 1000000033 (Other Identifier: Catalogue of RWD studies)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No