An observational study in Insomnia, sponsored by Idorsia Pharmaceuticals Ltd.. Terminated at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Idorsia Pharmaceuticals Ltd. · Observational
The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)
Canada, France, Germany, Italy, Spain, United Kingdom
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 3 is below the median of 138 across 318 observational studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Idorsia Pharmaceuticals Ltd. is the lead sponsor of 103 studies on the registry; 4 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 9 (31%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
A) Eligibility criteria for prospective pregnancies:
Inclusion Criteria:
One of the following:
Exclusion Criteria:
B) Eligibility criteria for retrospective pregnancies:
Inclusion criteria:
Exclusion criteria:
Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Drug: Daridorexant
Women exposed to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
Drug: Non-orexin receptor antagonist medications for insomnia
Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
Other: No insomnia medication
Dosing 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.
Also known as: QUVIVIQ
Dosing 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 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.
Time frame: Start of pregnancy up to 1 year of infant age
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.
Time frame: 20 weeks gestation until delivery/birth/labor
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).
Time frame: 20 weeks gestation until delivery/birth/labor
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.
Time frame: Start of pregnancy up to 37 weeks gestation
Pregnancy complications - number of participants with gestational diabetes
Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy.
Time frame: Start of pregnancy until delivery/birth/labor
Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination
Any induced or voluntary fetal loss during pregnancy.
Time frame: Start of pregnancy until delivery/birth/labor
Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion
Loss of a fetus due to natural causes at less than 20 weeks of gestation.
Time frame: Start of pregnancy up to 20 weeks gestation
Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth
Death of a fetus at or after 20 weeks of gestation.
Time frame: 20 weeks gestation up to birth
Pregnancy outcomes - number of participants with pregnancy outcome of live birth
Birth of a surviving neonate.
Time frame: 37 weeks gestation up to 40 weeks gestation
Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth
Live birth prior to 37 weeks gestation: early preterm (\< 34 weeks), late preterm (34-36 weeks), and early term (37-38 weeks).
Time frame: Less than 34 weeks gestation up to 37 weeks gestation
Infant outcomes - number of infants with outcome of minor congenital malformations classified according to MACDP
Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential minor congenital malformations will be evaluated by at least 3, qualified, independent teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
Time frame: Start of pregnancy up to 1 year of infant age
Infant outcomes - infants categorized according to size for gestational age
All live births will be classified using the World Health Organization definition of birth weight, i.e., small (below the 10th percentile), appropriate (between the 10th and 90th percentile), or large (above the 90th percentile) for gestational age.
Time frame: At birth of infant
Infant outcomes - number of infants with outcome of low birth weight
Birth weight of less than 2500 g; subclassified into very low birth weight (\< 1500 g) and moderately low birth weight (1500 g to 2499 g).
Time frame: At birth of infant
Infant outcomes - number of infants with outcome of infant death
Death of a live-born infant within the first year of life; subclassified as neonatal deaths (≤ 28 days of life) and infant deaths (29 to 365 days of life).
Time frame: Birth of infant up to 1 year of infant age
Infant outcomes - number of infants with outcome of hospitalization for serious illness
In-patient admissions for treatment of potentially life threatening illnesses among live-born infants within the first year of life.
Time frame: Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - weight-for-length
World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-length percentiles (weight in kilograms, length in centimeters).
Time frame: Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - head circumference-for-age
World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific head circumference-for-age percentiles (head circumference in centimeters, age in months and years).
Time frame: Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - length-for-age
World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific length-for-age percentiles (length in centimeters, age in months and years).
Time frame: Birth of infant up to 1 year of infant age
Infant outcomes - postnatal growth and development - weight-for-age
World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-age percentiles (weight in kilograms, age in months and years).
Time frame: Birth of infant up to 1 year of infant age
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Sep 2026, 22 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Mar 2033 → Sep 2026 and completion Mar 2033 → Sep 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)
Canada, France, Germany, Italy, Spain, United Kingdom
The study, in its current operational format, has been terminated. However, data collection will continue through the National Pregnancy Registry for Psychiatric Medications (NPRPM), which is conducted by Massachusetts General Hospital (NCT01246765)
Canada, France, Germany, Italy, Spain, United Kingdom
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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