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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia Disorder
• Intervention / Treatment: Drug: Daridorexant; Drug: Non-orexin receptor antagonist insomnia medication; Other: No insomnia medication

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 Type: Observational
• Enrollment (Estimated): 2095

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19801
      • Carelon Research

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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. Date of conception ≥ 42 weeks before the end of the intake period.
4. Age 15 to 50 years at the date of conception.
5. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the end of pregnancy.
6. 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.
7. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QUVIVIQ-exposed group; Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception.	Drug: Daridorexant; Daridorexant received during or shortly prior to pregnancy.; Other Names: QUVIVIQ
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; Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.
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; No insomnia medication received during or shortly prior to pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of spontaneous abortions (SABs)	An SAB is defined as the loss of an embryo before 20 gestational weeks (identified through maternal claims).	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).	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).	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).	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).	From May 2022 to April 2028 (6 years)

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Collaborators: Carelon Research
• Investigators: Study Director: Clinical Trials Study Director, Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: ID-078A404

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