Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

NCT06393504 | Active Not Recruiting FDA Drug

• 1 other identifier: ID-078A404
• Study Type: observational
• Target: 2,095
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy

Conditions

Insomnia Disorder

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  From May 2022 to April 2028 (6 years)

Secondary Outcomes (5)

• Prevalence of spontaneous abortions (SABs)

  From May 2022 to April 2028 (6 years)

• Prevalence of stillbirths (SBs)

  From May 2022 to April 2028 (6 years)

• Prevalence of small for gestational age infants (SGAs)

  From May 2022 to April 2028 (6 years)

• Prevalence of preterm births (PTBs)

  From May 2022 to April 2028 (6 years)

• Prevalence of induced abortions (IABs)

  From May 2022 to April 2028 (6 years)

Study Arms (3)

QUVIVIQ-exposed group

Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception.

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.

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.

Other: No insomnia medication

Interventions

Daridorexant DRUG

Daridorexant received during or shortly prior to pregnancy.

Also known as: QUVIVIQ

QUVIVIQ-exposed group

Non-orexin receptor antagonist insomnia medication DRUG

Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.

Active comparator group

No insomnia medication OTHER

No insomnia medication received during or shortly prior to pregnancy.

Unexposed comparator group

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 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.

1. Evidence of a singleton end of pregnancy event during the intake period. 2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy. 3. 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). 4. Age 15 to 50 years at the date of conception. 5. 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. 6. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead
• Carelon Research: collaborator

Study Sites (1)

Carelon Research

Wilmington, Delaware, 19801, United States

Location

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: November 30, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)