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

NCT ID: NCT06744673

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 861 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2025-12-30

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.

Detailed Description

As this is a Retrospective Database study, the Study Start Date for this study references the date at which data will become available

Conditions

Sleep Initiation and Maintenance Disorders; Pregnancy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

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.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

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.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

Interventions

No Intervention

This is a non-interventional study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Must be female.

2. Must be 16 to 49 years of age

3. Has a clinically recognized pregnancy that overlaps with the data collection period between 01 Jun 2020 and the end of the data collection period

4. 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:

1. 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

2. 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:

1. 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)

2. 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:

1. 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

2. 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

Exclusion Criteria

1. Identified pregnancies with exposure to known teratogens during pregnancy, that is, from 14 days after the LMP to pregnancy outcome (any trimester) or to dual orexin receptor antagonists other than lemborexant (this includes, but it is not limited to, exclusion of suvorexant and daridorexant) from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (any trimester) will be excluded

2. Pregnancies not associated with a known pregnancy outcome.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Trial Site #1

Nutley, New Jersey, United States

Countries

United States

Other Identifiers

E2006-A001-604

Identifier Type: -

Identifier Source: org_study_id