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

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
Drug
summary

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

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

summary

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