This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Diagnosis of insomnia disorder prior to pregnancy.
Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.
Diagnosis of insomnia disorder prior to pregnancy.
Pregnancy has ended.
Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Women with insomnia disorder, monitored in a standard-of-care setting, and pregnant at time of enrollment (prospective pregnancies) will be assigned to a specific cohort according to the insomnia medication received. Women with insomnia disorder for whom the outcome of pregnancy is known prior to enrollment (retrospective pregnancies) will be analyzed in a separate case series.
Cohort
Other
Daridorexant
DrugDosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
Non-orexin receptor antagonist medications for insomnia
DrugDosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
No insomnia medication
Other interventionNo insomnia medication was administered.
Major congenital malformations classified according to MACDP
Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
Pregnancy complications - number of participants with pre-eclampsia
The presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with previously normal blood pressure) and proteinuria; or, in the absence of proteinuria, a new onset of hypertension accompanied by one of the following conditions: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms.
Pregnancy complications - number of participants with pregnancy-induced hypertension
High blood pressure associated with pregnancy, as diagnosed by the treating healthcare provider, i.e., elevated (systolic between 120-129 mmHg and diastolic less than 80 mmHg); Stage 1 hypertension (systolic between 130-139 mmHg or diastolic between 80-89 mmHg); or Stage 2 hypertension (systolic at least 140 mmHg or diastolic at least 90 mmHg).
Pregnancy complications - number of participants with pre-term labor
Regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy.
Pregnancy complications - number of participants with gestational diabetes
Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy.
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Idorsia Pharmaceuticals Ltd.
Lead sponsor
IQVIA Pty Ltd
Collaborator
