Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10871781occurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnessother1receivedateformat102Date Received26/02/2015receiptdateformat102Date Last Updated26/02/2015fulfillexpeditecriteria1companynumb2015SP000572duplicate1

Report Duplicate

duplicatesourceSUNOVIONduplicatenumb2015SP000572

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionAnxietyOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionDiabetes mellitusOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionHypertensionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductGENERIC ESZOPICLONEdrugauthorizationnumb021476drugstructuredosagenumb3drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAactiondrug4

activesubstance

activesubstancenameESZOPICLONE

2)

drugcharacterization2medicinalproductAMBIEN

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)

drugcharacterization2medicinalproductCLONAZEPAM.

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductXANAX

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

5)

drugcharacterization2medicinalproductLUNESTAdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIA

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

6)

drugcharacterization2medicinalproductDALMANE

activesubstance

activesubstancenameFLURAZEPAM HYDROCHLORIDE

7)

drugcharacterization2medicinalproductWELLBUTRIN XL

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515Brand NameWELLBUTRIN XLGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLCproduct_ndc0187-0730, 0187-0731Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21Package NDC0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07UNIIZG7E5POY8O

8)

drugcharacterization2medicinalproductDESYREL

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

9)

drugcharacterization2medicinalproductREMERON

activesubstance

activesubstancenameMIRTAZAPINE

openFDA Info on Medication

Application NumberNDA020415Brand NameREMERONGeneric NameMIRTAZAPINEManufacturersOrganon LLCproduct_ndc78206-160, 78206-161, 78206-156, 78206-158, 78206-159Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINEspl_id3dc49c6b-23a6-41ed-909e-98b5c179130fspl_set_id98ad1917-a094-44f5-a28f-a64a8cfcd887Package NDC 78206-160-01, 78206-161-01, 78206-156-99, 78206-156-01, 78206-158-99, 78206-158- ... UNIIA051Q2099Q