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

December 1, 2025 updated by: Idorsia Pharmaceuticals Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
785

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Jodha Tishon
  • France
      • Montpellier, France
        • Not yet recruiting
        • Hôpital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major congenital malformations classified according to MACDP
Time Frame: Start of pregnancy up to 1 year of infant age
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pregnancy complications - number of participants with pre-eclampsia
Time Frame: 20 weeks gestation until delivery/birth/labor
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
Time Frame: 20 weeks gestation until delivery/birth/labor
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
Time Frame: Start of pregnancy up to 37 weeks gestation
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
Time Frame: Start of pregnancy until delivery/birth/labor
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
Time Frame: Start of pregnancy until delivery/birth/labor
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
Time Frame: Start of pregnancy up to 20 weeks gestation
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
Time Frame: 20 weeks gestation up to birth
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
Time Frame: 37 weeks gestation up to 40 weeks gestation
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
Time Frame: Less than 34 weeks gestation up to 37 weeks gestation
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
Time Frame: Start of pregnancy up to 1 year of infant age
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
Time Frame: At birth of infant
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
Time Frame: At birth of infant
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
Time Frame: Birth of infant up to 1 year of infant age
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
Time Frame: Birth of infant up to 1 year of infant age
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
Time Frame: Birth of infant up to 1 year of infant 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-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
Time Frame: Birth of infant up to 1 year of infant 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
Time Frame: Birth of infant up to 1 year of infant 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
Time Frame: Birth of infant up to 1 year of infant 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idorsia Pharmaceuticals Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials Study Director, Idorsia Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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