Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10333083primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received22/07/2014receiptdateformat102Date Last Updated22/07/2014fulfillexpeditecriteria2companynumbUS-SANOFI-AVENTIS-2013SA083437duplicate1

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SANOFI-AVENTIS-2013SA083437

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age74Unit of Onset Ageyearspatientagegroup6SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionNauseaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.1ReactionWeight decreasedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.1ReactionHeadacheOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.1ReactionDizzinessOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.1ReactionFeeling abnormalOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.1ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLPIDEM TARTRATE EXTENDED RELEASEdrugbatchnumbUNKNOWNdrugauthorizationnumb021774drugstructuredosagenumb6.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformMODIFIED-RELEASE TABLETdrugadministrationroute048drugstartdateformat102drugstartdate10/08/2013drugenddateformat102drugenddate01/09/2013actiondrug1

activesubstance

activesubstancenameZOLPIDEM TARTRATE

2)

drugcharacterization2medicinalproductSONATA

activesubstance

activesubstancenameZALEPLON

3)

drugcharacterization2medicinalproductALL OTHER THERAPEUTIC PRODUCTS

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

4)

drugcharacterization2medicinalproductLUNESTAdrugbatchnumbUNKNOWNdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextTAKEN FROM-10 YEARSdrugadministrationroute065

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