InsomniaNCT06498128
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
An observational study of Insomnia, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Daridorexant, Non-orexin receptor antagonist medications for insomnia and No insomnia medication
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 22 Sep 2026
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
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- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy has ended.
- Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Who cannot join
- 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.
- Eligibility criteria for retrospective pregnancies:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Insomnia
- Being tested
- Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication
- Keywords
- Pregnancy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Also called QUVIVIQ
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.
Non-orexin receptor antagonist medications for insomniaDrug
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 medicationOther
No insomnia medication was administered.
| Study group | Role | What they receive |
|---|---|---|
| QUIVIQ (Cohort A) | Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception. Receives: 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. Receives: 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. Receives: Other: No insomnia medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of pregnancy up to 1 year of infant age
Secondary outcomes (18)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 weeks gestation up to birth
Pregnancy outcomes - number of participants with pregnancy outcome of live birth
Birth of a surviving neonate.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Birth of infant up to 1 year of infant age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start21 Nov 2024
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Why it stopped: The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3 participants (actual)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Study Director, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498128
- Sponsor's protocol ID
- ID-078A403
- Other IDs
- 1000000033
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUVIVIQ® Pregnancy Registry
- ClinicalTrials.gov ID
- NCT06498128
- Acronym / sponsor ID
- ID-078A403
- Conditions
- Insomnia
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 22 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 21 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QUIVIQ (Cohort A) | – | Drug: DaridorexantWomen with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception. |
| Non-orexin receptor antagonist medications for insomnia (Cohort B1) | – | Drug: Non-orexin receptor antagonist medications for insomniaWomen 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. |
| No insomnia medications (Cohort B2) | – | Other: No insomnia medicationWomen who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy has ended.
Key exclusion criteria (3 listed)
- 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.
- Eligibility criteria for retrospective pregnancies:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaridorexantAlso: QUVIVIQDosing 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. | Drug | QUIVIQ (Cohort A) |
| Non-orexin receptor antagonist medications for insomniaDosing 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. | Drug | Non-orexin receptor antagonist medications for insomnia (Cohort B1) |
| No insomnia medicationNo insomnia medication was administered. | Other | No insomnia medications (Cohort B2) |
Primary outcome
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.
18 secondary outcomes
Pregnancy complications - number of participants with pre-eclampsia
Time frame: 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
Pregnancy complications - number of participants with pre-term labor
Time frame: 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
Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination
Time frame: 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
Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth
Time frame: 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
Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth
Time frame: 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
Infant outcomes - infants categorized according to size for gestational age
Time frame: At birth of infant
Infant outcomes - number of infants with outcome of low birth weight
Time frame: 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
Infant outcomes - number of infants with outcome of hospitalization for serious illness
Time frame: 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
Infant outcomes - postnatal growth and development - head circumference-for-age
Time frame: 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
Infant outcomes - postnatal growth and development - weight-for-age
Time frame: Birth of infant up to 1 year of infant age
Results and safety
The study was stopped early (reason given: The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials Study Director study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major congenital malformations classified according to MACDP (time frame: Start of pregnancy up to 1 year of infant age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.