Insomnia DisorderNCT06393504
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
An observational study of Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
Trial summary
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Daridorexant, Non-orexin receptor antagonist insomnia medication and No insomnia medication
- How many people
- 2,095 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 an end of pregnancy event between 1 May 2022 and 31 May 2027 (called the "intake period") and a diagnosis of insomnia disorder are included in the base cohort, from which the exposure- and outcome-specific analytic cohorts will be created.
- Evidence of a singleton end of pregnancy event during the intake period.
- ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy.
- Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the date of conception plus 40 weeks (equivalent to 42 gestational weeks).
- Age 15 to 50 years at the date of conception.
- No dispensing of known or suspected teratogenic medications during the period which begins 5 half lives of that medication prior to the date of conception and ends at the end of pregnancy.
- No exposure to other orexin receptor antagonists during the exposure period, i.e., suvorexant, lemborexant, and any orexin receptor antagonists newly approved during the intake period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthcare Claims Database Study to Provide Safety Information on Maternal, Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) During Pregnancy
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
Read the detailed description
This is a longitudinal observational cohort study using an electronic database of healthcare claims data. Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes. The study will include two phases, a patient accrual phase (Phase 1) and an analysis phase (Phase 2).
Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses. Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 1:4 ratio of exposed:active comparator patients.
Analysis of the prevalence of each specific pregnancy or infant outcome will comprise: (1) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy (active comparator group); (2) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy (unexposed comparator group).
- Conditions
- Insomnia Disorder
- Being tested
- Daridorexant, Non-orexin receptor antagonist insomnia medication, 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
Daridorexant received during or shortly prior to pregnancy.
Non-orexin receptor antagonist insomnia medicationDrug
Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.
No insomnia medicationOther
No insomnia medication received during or shortly prior to pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| QUVIVIQ-exposed group | Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception. Receives: Drug: Daridorexant | |
| Active comparator group | Pregnant women with insomnia exposed to non-orexin receptor antagonist insomnia medications during pregnancy or within 5 half-lives of the respective insomnia medication prior to date of conception. Receives: Drug: Non-orexin receptor antagonist insomnia medication | |
| Unexposed comparator group | Pregnant women with insomnia unexposed to insomnia medications during pregnancy and within 5 half-lives of any insomnia medication taken prior to date of conception. Receives: Other: No insomnia medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of major congenital malformations (MCMs)
MCMs will be identified as pre-specified diagnostic codes for malformations included in the National Birth Defects Prevention Network's birth defects descriptions (identified through maternal and infant claims).
MCMs with etiologies presumed not to be associated with drug exposure, such as chromosomal abnormalities, genetic syndromes, prematurity-related defects, and positional effects, will be excluded from the definition of MCMs.
Measured: From May 2022 to April 2028 (6 years)
Secondary outcomes (5)
Prevalence of spontaneous abortions (SABs)
An SAB is defined as the loss of an embryo before 20 gestational weeks (identified through maternal claims).
Measured: From May 2022 to April 2028 (6 years)
Prevalence of stillbirths (SBs)
An SB is defined as the loss of a fetus at or after 20 gestational weeks (identified through maternal claims).
Measured: From May 2022 to April 2028 (6 years)
Prevalence of small for gestational age infants (SGAs)
SGA is defined as birth weight less than or equal to the tenth percentile for gestational age (identified through maternal and infant claims).
Measured: From May 2022 to April 2028 (6 years)
Prevalence of preterm births (PTBs)
PTB is defined as a live birth before 37 gestational weeks (identified through maternal and infant claims).
Measured: From May 2022 to April 2028 (6 years)
Prevalence of induced abortions (IABs)
An IAB is defined as the elective termination of the pregnancy (identified through maternal claims).
Measured: From May 2022 to April 2028 (6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 Nov 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies 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
- Retrospective
- Enrolment
- 2,095 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carelon Research
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Study Director, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393504
- Sponsor's protocol ID
- ID-078A404
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2024
- Last updated
- 19 Aug 2025
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Claims Database Study to Provide Safety Information on Maternal, Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) During Pregnancy
- ClinicalTrials.gov ID
- NCT06393504
- Acronym / sponsor ID
- ID-078A404
- Conditions
- Insomnia Disorder
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,095 participants (estimated)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Carelon Research
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 May 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.
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
Detailed description
This is a longitudinal observational cohort study using an electronic database of healthcare claims data. Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes. The study will include two phases, a patient accrual phase (Phase 1) and an analysis phase (Phase 2).
Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses. Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 1:4 ratio of exposed:active comparator patients.
Analysis of the prevalence of each specific pregnancy or infant outcome will comprise: (1) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy (active comparator group); (2) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy (unexposed comparator group).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QUVIVIQ-exposed group | – | Drug: DaridorexantPregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception. |
| Active comparator group | – | Drug: Non-orexin receptor antagonist insomnia medicationPregnant women with insomnia exposed to non-orexin receptor antagonist insomnia medications during pregnancy or within 5 half-lives of the respective insomnia medication prior to date of conception. |
| Unexposed comparator group | – | Other: No insomnia medicationPregnant women with insomnia unexposed to insomnia medications during pregnancy and within 5 half-lives of any insomnia medication taken prior to date of conception. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women with an end of pregnancy event between 1 May 2022 and 31 May 2027 (called the "intake period") and a diagnosis of insomnia disorder are included in the base cohort, from which the exposure- and outcome-specific analytic cohorts will be created.
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: QUVIVIQDaridorexant received during or shortly prior to pregnancy. | Drug | QUVIVIQ-exposed group |
| Non-orexin receptor antagonist insomnia medicationNon-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy. | Drug | Active comparator group |
| No insomnia medicationNo insomnia medication received during or shortly prior to pregnancy. | Other | Unexposed comparator group |
Primary outcome
Prevalence of major congenital malformations (MCMs)
Time frame: From May 2022 to April 2028 (6 years)
MCMs will be identified as pre-specified diagnostic codes for malformations included in the National Birth Defects Prevention Network's birth defects descriptions (identified through maternal and infant claims). MCMs with etiologies presumed not to be associated with drug exposure, such as chromosomal abnormalities, genetic syndromes, prematurity-related defects, and positional effects, will be excluded from the definition of MCMs.
5 secondary outcomes
Prevalence of spontaneous abortions (SABs)
Time frame: From May 2022 to April 2028 (6 years)
Prevalence of stillbirths (SBs)
Time frame: From May 2022 to April 2028 (6 years)
Prevalence of small for gestational age infants (SGAs)
Time frame: From May 2022 to April 2028 (6 years)
Prevalence of preterm births (PTBs)
Time frame: From May 2022 to April 2028 (6 years)
Prevalence of induced abortions (IABs)
Time frame: From May 2022 to April 2028 (6 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- 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 Disorder, 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?
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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of major congenital malformations (MCMs) (time frame: From May 2022 to April 2028 (6 years)). 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 19 Aug 2025.