XYREM

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Ireland, Italy, Lithuania, Netherlands, Poland, Spain, Turkey, UK.

Active ingredients

The drug XYREM contains one active pharmaceutical ingredient (API):

1	Sodium oxybate UNII 7G33012534 - SODIUM OXYBATE
	Sodium oxybate is a central nervous system depressant which reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented nighttime sleep. The precise mechanism by which sodium oxybate produces an effect is unknown, however sodium oxybate is thought to act by promoting slow (delta) wave sleep and consolidating night-time sleep.
	Read more about Sodium oxybate

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
XYREM Oral solution	MPI, US: SPL/PLR	FDA, National Drug Code (US)
XYREM Oral solution	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
N07XX04	Hydroxybutyric acid	N Nervous system → N07 Other nervous system drugs → N07X Other nervous system drugs → N07XX Other nervous system drugs
Discover more medicines within N07XX04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02268272
EE	Ravimiamet	1220870
ES	Centro de información online de medicamentos de la AEMPS	05312001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	020333
FR	Base de données publique des médicaments	60913012
GB	Medicines & Healthcare Products Regulatory Agency	100709
IE	Health Products Regulatory Authority	88567
IT	Agenzia del Farmaco	036964017
LT	Valstybinė vaistų kontrolės tarnyba	1031426
PL	Rejestru Produktów Leczniczych	100000362
TR	İlaç ve Tıbbi Cihaz Kurumu	8699624650047
US	FDA, National Drug Code	68727-100