Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11294948primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received22/07/2015receiptdateformat102Date Last Updated22/07/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight49.9SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionDecreased activity

2)

reactionmeddraversionpt18.1ReactionSomnambulism

3)

reactionmeddraversionpt18.1ReactionRestlessness

4)

reactionmeddraversionpt18.1ReactionFeeling abnormal

5)

reactionmeddraversionpt18.1ReactionAbnormal dreams

6)

reactionmeddraversionpt18.1ReactionHallucination

Drug

1)

drugcharacterization2medicinalproductLUNESTA

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)

drugcharacterization1medicinalproductBELSOMRAdrugbatchnumb442192drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCOATED TABLETdrugadministrationroute048drugindicationSLEEP DISORDERdrugadditional1

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)

drugcharacterization2medicinalproductATIVAN

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, Hikma Pharmaceuticals USA Inc.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMRXCUI 104719, 197900, 197901, 197902, 206821, 206828, 206819, 206820, 238100, 238101, ... spl_id0c599118-4213-4a51-bd2d-a162ac18a940, 2d4cea58-1dfe-4bc0-bd5a-415ced5420dbspl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

summary

narrativeincludeclinicalCASE EVENT DATE: 20150718