[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554364":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":131,"collaborators":133,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":10,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":149,"studyType":150,"phases":10,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Idorsia Pharmaceuticals Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"QUIVIQ (Cohort A)",null,"Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.",[13],"Drug: Daridorexant",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-orexin receptor antagonist medications for insomnia (Cohort B1)","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.",[18],"Drug: Non-orexin receptor antagonist medications for insomnia",{"label":20,"type":10,"description":21,"interventionNames":22},"No insomnia medications (Cohort B2)","Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.",[23],"Other: No insomnia medication",[25,32,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Daridorexant","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.",[9],[31],"QUVIVIQ",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Non-orexin receptor antagonist medications for insomnia","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.",[15],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"OTHER","No insomnia medication","No insomnia medication was administered.",[20],[42],{"name":43,"affiliation":5,"role":44},"Clinical Trials Study Director","STUDY_DIRECTOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Clinical Trial Information USA","CONTACT","+1 856 661 37 21","idorsiaclinicaltrials@idorsia.com",{"name":52,"role":48,"phone":53,"phoneExt":10,"email":50},"Clinical Trial Information Europe","+41 58 844 19 77",[55,69,81,91,101,111,121],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":10},"IQVIA US Office","RECRUITING","Durham","North Carolina","27703","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-78.89862,35.99403,{"lat":67,"lon":66},{"facility":70,"status":71,"city":72,"state":73,"zip":10,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":10},"Jodha Tishon","NOT_YET_RECRUITING","Toronto","Ontario","Canada","CA",{"type":64,"coordinates":77},[78,79],-79.39864,43.70643,{"lat":79,"lon":78},{"facility":82,"status":71,"city":83,"state":10,"zip":10,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":10},"Hôpital Gui de Chauliac","Montpellier","France","FR",{"type":64,"coordinates":87},[88,89],3.87635,43.61093,{"lat":89,"lon":88},{"facility":92,"status":71,"city":93,"state":10,"zip":10,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":10},"Charité - Universitätsmedizin Berlin","Berlin","Germany","DE",{"type":64,"coordinates":97},[98,99],13.41053,52.52437,{"lat":99,"lon":98},{"facility":102,"status":71,"city":103,"state":10,"zip":10,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":10},"Azienda Ospedaliera Universitaria Policlinico Tor Vergata","Rome","Italy","IT",{"type":64,"coordinates":107},[108,109],12.51133,41.89193,{"lat":109,"lon":108},{"facility":112,"status":71,"city":113,"state":10,"zip":10,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":10},"Hospital Txagorritxu","Vitoria-Gasteiz","Spain","ES",{"type":64,"coordinates":117},[118,119],-2.67268,42.84998,{"lat":119,"lon":118},{"facility":122,"status":71,"city":123,"state":10,"zip":10,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":10},"University College London Hospitals","London","United Kingdom","UK",{"type":64,"coordinates":127},[128,129],-0.12574,51.50853,{"lat":129,"lon":128},{"type":132,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[134],{"name":135,"class":6},"IQVIA Pty Ltd","100554364","registry-to-collect-information-on-pregnancy-neonatal-and-infant-outcomes-in-pregnant-women-exposed-to-quviviq-100554364",false,"NCT06498128","Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®","QUVIVIQ® Pregnancy Registry","A) Eligibility criteria for prospective pregnancies:\n\nInclusion Criteria:\n\n1. Diagnosis of insomnia disorder prior to pregnancy.\n2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.\n3. One of the following:\n\n   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.\n   2. 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.\n   3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.\n\nExclusion Criteria:\n\n* 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.\n\nB) Eligibility criteria for retrospective pregnancies:\n\nInclusion criteria:\n\n1. Diagnosis of insomnia disorder prior to pregnancy.\n2. Pregnancy has ended.\n3. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.\n\nExclusion criteria:\n\n* Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.","FEMALE","15 Years","50 Years",{"count":147,"type":148},785,"ESTIMATED","21 Months","OBSERVATIONAL","This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.",[153],"Insomnia",[155],"Pregnancy","2025-12-01",{"date":158,"type":159},"2025-12-02","ACTUAL",{"date":161,"type":159},"2024-11-21",{"date":163,"type":148},"2033-03",{"name":5,"class":6},7]