A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

NCT06744673 | Active Not Recruiting FDA Drug

• 1 other identifier: E2006-A001-604
• Study Type: observational
• Target: 861
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are not exposed to any prescription insomnia drugs at any time during the pregnancy and to compare the occurrence of MCMs among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.

Conditions

Sleep Initiation and Maintenance Disorders; Pregnancy

Keywords

Insomnia; Pregnancy; Dayvigo; Lemborexant; E2006

Outcome Measures

Primary Outcomes (2)

• Percentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort C

  MCM will be defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Congenital anomalies will be classified using the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) system. Live birth will be defined as birth of a living fetus at greater than or equal to (\>=) 20 gestational weeks or, if gestational age is unknown, a fetus weighing \>=350 grams (g). Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy.

  At estimated date of delivery (EDD)/pregnancy outcome (up to 1 year 10 months)

• Percentage of Live Births Reported With MCM in Women of Cohort A and Cohort B Subsets

  MCM will be defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and Cohort B subset is defined as women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.

  At EDD/pregnancy outcome (up to 1 year 10 months)

Secondary Outcomes (19)

• Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A and Cohort B Subsets

  At EDD/pregnancy outcome (up to 1 year 10 months)

• Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A Subset and Cohort C

  At EDD/pregnancy outcome (up to 1 year 10 months)

• Percentage of Participants With Spontaneous Abortion (SAB) in Cohort A and Cohort B Subsets

  From enrollment up to pregnancy outcome (up to 1 year 10 months)

• Percentage of Participants With SAB in Cohort A Subset and Cohort C

  From enrollment up to pregnancy outcome (up to 1 year 10 months)

• Percentage of Participants With Stillbirth in Cohort A and Cohort B Subsets

  From 20 gestational weeks up to pregnancy outcome (up to 1 year 10 months)

Study Arms (3)

Cohort A: Dayvigo-exposed Cohort

Pregnant women participants with a diagnosis of insomnia within the 6 months before the estimated date of conception (DOC) and who have received at least 1 dose of Dayvigo at any time from 10 days after the last menstrual period (LMP) that is, 4 days prior to the DOC, which is 5 times the product's half-life, until the pregnancy outcome (that is, any trimester) will be observed retrospectively.

Other: No Intervention

Cohort B: Comparator-exposed Cohort

Pregnant women participants with a diagnosis of insomnia within the 6 months before the estimated DOC and who have received at least 1 dose of drug indicated for the treatment of insomnia other than Dayvigo from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome, and no exposure to Dayvigo between 10 days after the LMP and the pregnancy outcome (that is, any trimester) will be observed retrospectively.

Other: No Intervention

Cohort C: Untreated Unexposed Comparator Cohort

Pregnant women participants with a diagnosis of insomnia within the 6 months before the estimated DOC and who were not exposed to any prescribed medication for the treatment of insomnia during pregnancy, that is, from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (that is, any trimester) will be observed retrospectively.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Cohort A: Dayvigo-exposed Cohort; Cohort B: Comparator-exposed Cohort; Cohort C: Untreated Unexposed Comparator Cohort

Eligibility Criteria

• Age: 16 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant women with insomnia.

You may qualify if:

• Must be female.
• Must be 16 to 49 years of age
• Has a clinically recognized pregnancy that overlaps with the data collection period between 01 Jun 2020 and the end of the data collection period
• Has continuous medical and pharmacy benefit coverage for a minimum of 6 months (Baseline Period) before the estimated date of conception and through the date of pregnancy outcome.
• Cohort A:
• Exposed to at least 1 dose of Dayvigo at any time from 10 days after the LMP, that is, approximately 4 days prior to the estimated DOC, defined as 14 days after the LMP, based on the product's half-life, until the pregnancy outcome
• Has a diagnosis of insomnia recorded in her electronic healthcare data within 6 months before the estimated DOC, insomnia defined as an International Classification of Disease (ICD) 10-CM code G47.0x Insomnia or ICD 10 CM code F51.0x Insomnia not due to a substance or known physiological condition or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) code 780.52. Or if the first exposure to Dayvigo occurs after the DOC, then must have a diagnostic code for insomnia prior to or on the first exposure to this drug.
• Cohort B:
• Exposed to at least 1 dose of prescription medication for insomnia other than Dayvigo from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (that is, any trimester)
• Has a diagnosis of insomnia recorded in her electronic healthcare data within 6 months before the estimated DOC, insomnia defined as an ICD 10-CM code G47.0x Insomnia or ICD 10 CM code F51.0x Insomnia not due to a substance or known physiological condition or DSM-5 code 780.52. Or if the first exposure to the prescription insomnia medication occurs after the DOC, then must have a diagnostic code for insomnia prior to or on the first exposure to this drug
• Cohort C:
• Not exposed to any prescription medication for the treatment of insomnia during pregnancy that is, from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (that is, any trimester). NB: May be exposed during pregnancy to other drugs (that is, not for insomnia), but only provided that these are not associated with potential or known teratogenicity
• Has a diagnosis of insomnia recorded in her electronic healthcare data within 6 months before the estimated DOC, insomnia defined as an ICD 10-CM code G47.0x Insomnia or ICD 10 CM code F51.0x Insomnia not due to a substance or known physiological condition or DSM-5 code 780.52

You may not qualify if:

• Pregnancies not associated with a known pregnancy outcome.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Eisai Trial Site #1

Nutley, New Jersey, 07110, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 3, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)