sodium oxybate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4566	502-85-2

Description:

Molecule	Description
Synonyms: gamma hydroxybutyric acid sodium oxybate sodium hydroxybutyrate xyrem oxybate	The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA. Molecular weight: 126.09 Formula: C4H7NaO3 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 60.36 ALOGS: ROTB: None

Molecule

Description

Synonyms:

gamma hydroxybutyric acid
sodium oxybate
sodium hydroxybutyrate
xyrem
oxybate

The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.

Molecular weight: 126.09
Formula: C4H7NaO3
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 60.36
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
7.50	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
July 17, 2002	FDA	JAZZ PHARMS

FDA Adverse Event Reporting System (Female)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pre-existing condition improved	1277.13	18.57	402	48050	7842	63432728
Sleep apnoea syndrome	1226.84	18.57	546	47906	28587	63411983
Anxiety	822.05	18.57	917	47535	216624	63223946
Suicidal ideation	718.19	18.57	497	47955	61924	63378646
Somnolence	655.14	18.57	742	47710	177943	63262627
Depression	637.13	18.57	766	47686	195726	63244844
Somnambulism	634.29	18.57	215	48237	5328	63435242
Feeling abnormal	534.68	18.57	611	47841	147781	63292789
Surgery	509.54	18.57	326	48126	35586	63404984
Product administration interrupted	500.46	18.57	174	48278	4662	63435908

Showing 1 to 10 of 322 entries

Previous1 2 3 4 5…33Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Sleep apnoea syndrome	746.64	24.84	303	16694	20018	34919916
Pre-existing condition improved	488.42	24.84	133	16864	2459	34937475
Suicidal ideation	347.03	24.84	226	16771	40162	34899772
Depression	330.28	24.84	314	16683	96784	34843150
Product use issue	256.75	24.84	226	16771	62990	34876944
Product administration interrupted	250.36	24.84	73	16924	1742	34938192
Somnambulism	240.14	24.84	80	16917	2992	34936942
Somnolence	232.91	24.84	278	16719	110838	34829096
Anxiety	205.38	24.84	247	16750	99181	34840753
Feeling abnormal	204.22	24.84	199	16798	63036	34876898

Showing 1 to 10 of 120 entries

Previous1 2 3 4 5…12Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Sleep apnoea syndrome	775.66	19.59	366	36839	36112	79671071
Somnolence	676.35	19.59	686	36519	238295	79468888
Pre-existing condition improved	556.51	19.59	173	37032	5390	79701793
Feeling abnormal	503.49	19.59	486	36719	158713	79548470
Anxiety	472.61	19.59	580	36625	247932	79459251
Somnambulism	469.42	19.59	153	37052	5568	79701615
Depression	456.50	19.59	533	36672	216257	79490926
Suicidal ideation	377.99	19.59	301	36904	76039	79631144
Enuresis	352.55	19.59	107	37098	3069	79704114
Product administration interrupted	306.65	19.59	101	37104	3798	79703385

Showing 1 to 10 of 256 entries

Previous1 2 3 4 5…26Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	N01AX11	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, GENERAL Other general anesthetics
ATC	N07XX04	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
CHEBI has role	CHEBI:35717	hypnotics
CHEBI has role	CHEBI:38869	general anaesthetic
CHEBI has role	CHEBI:50910	agente neurotoxico
CHEBI has role	CHEBI:53353	GHB receptor agonists
MeSH PA	D000759	Adjuvants, Anesthesia
MeSH PA	D000777	Anesthetics
MeSH PA	D018686	Anesthetics, Intravenous
MeSH PA	D002491	Central Nervous System Agents

Showing 1 to 10 of 11 entries

Previous1 2Next

Drug Use | Suggest Off label Use Form| |View source of the data|

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Narcolepsy	indication	60380001	DOID:8986
Cataplexy and narcolepsy	indication	193042000
Suicidal thoughts	contraindication	6471006
Alcoholism	contraindication	7200002
Alcohol intoxication	contraindication	25702006
Depressive disorder	contraindication	35489007
Hypertensive disorder	contraindication	38341003	DOID:10763
Chronic heart failure	contraindication	48447003
Succinate-semialdehyde dehydrogenase deficiency	contraindication	49748000
Acute nephropathy	contraindication	58574008

Showing 1 to 10 of 21 entries

Previous1 2 3Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	10675258	Jan. 11, 2033	TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	10213400	March 15, 2033	METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS SUFFERING FROM EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY WHO ARE CONCOMITANTLY ADMINISTERED SODIUM OXYBATE AND DIVALPROEX SODIUM
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	10864181	March 15, 2033	METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	11253494	March 15, 2033	METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS WHO ARE CONCOMITANTLY ADMINISTERED A SALT OF GAMMA-HYDROXYBUTYRATE AND DIVALPROEX SODIUM
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	11253494	March 15, 2033	METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	8772306	March 15, 2033	METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	8772306	March 15, 2033	METHOD OF TREATING PATIENTS WITH IDIOPATHIC HYPERSOMNIA WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	9050302	March 15, 2033	METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	9486426	March 15, 2033	METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	11426373	Sept. 19, 2037	TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB ADMINISTERED BETWEEN 2 AND 4 HOURS AFTER EATING

Showing 1 to 10 of 42 entries

Previous1 2 3 4 5Next

Orange Book exclusivity data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	July 21, 2023	NEW PRODUCT
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	Aug. 12, 2024	INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	July 21, 2027	INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	Aug. 12, 2028	THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	Oct. 26, 2025	INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	April 26, 2026	PEDIATRIC EXCLUSIVITY
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2026	NEW PRODUCT
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2030	TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2026	NEW PRODUCT
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2030	TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY

Showing 1 to 10 of 14 entries

Previous1 2Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
GABA-B receptor	GPCR	O75899 Q9UBS5	GABR2_HUMAN GABR1_HUMAN	AGONIST			CHEMBL	CHEMBL
Calcium/calmodulin-dependent protein kinase type II subunit alpha	Kinase	Q9UQM7	KCC2A_HUMAN		Ki	5.37	CHEMBL
Gamma-hydroxybutyrate receptor	Unclassified		Q6RY99_RAT		IC50	5.18	CHEMBL

Showing 1 to 3 of 3 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
006073	NDDF
006074	NDDF
1546380	RXNORM
16840	MMSL
23663870	PUBCHEM_CID
259470008	SNOMEDCT_US
326245	MMSL
4021348	VUID
4021348	VANDF
410917003	SNOMEDCT_US

Showing 1 to 10 of 25 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lumryz	HUMAN PRESCRIPTION DRUG LABEL	1	13551-001	FOR SUSPENSION, EXTENDED RELEASE	4.50 g	ORAL	NDA	21 sections
Lumryz	HUMAN PRESCRIPTION DRUG LABEL	1	13551-002	FOR SUSPENSION, EXTENDED RELEASE	6 g	ORAL	NDA	21 sections
Lumryz	HUMAN PRESCRIPTION DRUG LABEL	1	13551-003	FOR SUSPENSION, EXTENDED RELEASE	7.50 g	ORAL	NDA	21 sections
Lumryz	HUMAN PRESCRIPTION DRUG LABEL	1	13551-004	FOR SUSPENSION, EXTENDED RELEASE	9 g	ORAL	NDA	21 sections
sodium oxybate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-9628	SOLUTION	0.50 g	ORAL	NDA authorized generic	31 sections
sodium oxybate	HUMAN PRESCRIPTION DRUG LABEL	1	69238-2391	SOLUTION	0.50 g	ORAL	NDA authorized generic	31 sections
Xyrem	HUMAN PRESCRIPTION DRUG LABEL	1	68727-100	SOLUTION	0.50 g	ORAL	NDA	31 sections
Xyrem	HUMAN PRESCRIPTION DRUG LABEL	1	68727-100	SOLUTION	0.50 g	ORAL	NDA	31 sections
Xyrem	HUMAN PRESCRIPTION DRUG LABEL	1	68727-100	SOLUTION	0.50 g	ORAL	NDA	31 sections
Xyrem	HUMAN PRESCRIPTION DRUG LABEL	1	68727-100	SOLUTION	0.50 g	ORAL	NDA	31 sections

Showing 1 to 10 of 14 entries

Previous1 2Next