Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11210104primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious2receivedateformat102Date Received22/06/2015receiptdateformat102Date Last Updated04/11/2015fulfillexpeditecriteria2companynumbUS-009507513-1506USA005449duplicate1

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1506USA005449

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age27Unit of Onset AgeyearsWeight91.61SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionInsomniaOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionDissociationOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionInappropriate schedule of drug administrationOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionSleep disorderOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionCircadian rhythm sleep disorderOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionNightmareOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.1ReactionOverdoseOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionHallucination, visualOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.1ReactionSleep phase rhythm disturbanceOutcomeUnknown

10)

reactionmeddraversionpt18.1ReactionAttention deficit/hyperactivity disorderOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNKactiondrug5

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

2)

drugcharacterization1medicinalproductBELSOMRAdrugauthorizationnumb204569drugstructuredosagenumb.5drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 TAB,BIDdrugdosageformTABLETdrugadministrationroute048actiondrug1

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

3)

drugcharacterization1medicinalproductBELSOMRAdrugauthorizationnumb204569drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048actiondrug1

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20150516