Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10963300primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received27/03/2015receiptdateformat102Date Last Updated27/03/2015fulfillexpeditecriteria2companynumbUS-009507513-1503USA012937duplicate1

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1503USA012937

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionLethargyOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionAbdominal discomfortOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductBELSOMRAdrugauthorizationnumb204569drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QPMdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAactiondrug5

activesubstance

activesubstancenameSUVOREXANT

openFDA Info on Medication

Application NumberNDA204569Brand NameBELSOMRAGeneric NameSUVOREXANTManufacturersMerck Sharp & Dohme LLCproduct_ndc0006-0005, 0006-0033, 0006-0325, 0006-0335Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUVOREXANTRXCUI1547104, 1547110, 1547112, 1547114, 1547116, 1547118, 1547573, 1547575spl_id170ce41c-112a-46c9-956f-91ab07287bbfspl_set_ide5b72731-1acb-45b7-9c13-290ad12d3951Package NDC 0006-0005-10, 0006-0005-30, 0006-0005-13, 0006-0033-10, 0006-0033-30, 0006-0033- ... NUIN0000191000, N0000190998, N0000185503, N0000190114Established Pharmacologic ClassOrexin Receptor Antagonist [EPC]Mechanism of Action Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Cytochrome P ... UNII081L192FO9

2)

drugcharacterization2medicinalproductAMBIENdrugrecurreadministration3

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

3)

drugcharacterization2medicinalproductLUNESTAdrugrecurreadministration3

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE