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:

None

Approvals:

Date	Agency	Company	Orphan
July 17, 2002	FDA	JAZZ PHARMS

FDA Adverse Event Reporting System (Female)

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	1151.34	18.83	507	42200	23361	50539056
Pre-existing condition improved	1142.62	18.83	365	42342	6732	50555685
Anxiety	742.48	18.83	828	41879	176778	50385639
Somnolence	615.60	18.83	704	42003	154281	50408136
Somnambulism	575.51	18.83	199	42508	4725	50557692
Suicidal ideation	546.14	18.83	418	42289	54967	50507450
Depression	520.63	18.83	668	42039	164755	50397662
Feeling abnormal	501.19	18.83	572	42135	124920	50437497
Unevaluable event	437.25	18.83	340	42367	45726	50516691
Therapeutic response unexpected	406.27	18.83	219	42488	15696	50546721
Surgery	395.79	18.83	271	42436	29934	50532483
Enuresis	377.75	18.83	118	42589	2011	50560406
Migraine	301.51	18.83	344	42363	74936	50487481
Snoring	287.32	18.83	108	42599	3276	50559141
Initial insomnia	280.15	18.83	119	42588	4996	50557421
Weight decreased	244.55	18.83	561	42146	220684	50341733
Blood pressure increased	228.96	18.83	406	42301	132726	50429691
Insomnia	226.76	18.83	473	42234	174392	50388025
Feeling drunk	223.60	18.83	92	42615	3561	50558856
Hangover	205.29	18.83	67	42640	1322	50561095
Poor quality sleep	200.74	18.83	142	42565	16504	50545913
Parasomnia	185.13	18.83	47	42660	355	50562062
Condition aggravated	182.85	18.83	608	42099	296450	50265967
Panic attack	175.22	18.83	139	42568	19203	50543214
Bipolar disorder	172.42	18.83	93	42614	6664	50555753
Hunger	171.81	18.83	80	42627	4183	50558234
Product use issue	168.17	18.83	382	42325	149093	50413324
Sleep paralysis	167.43	18.83	46	42661	486	50561931
Abnormal dreams	166.77	18.83	102	42605	9275	50553142
Acute kidney injury	166.06	18.83	6	42701	228052	50334365
Tremor	147.78	18.83	310	42397	114593	50447824
Rash	147.49	18.83	94	42613	437377	50125040
Restless legs syndrome	141.33	18.83	113	42594	15784	50546633
Drug ineffective	140.25	18.83	303	42404	819030	49743387
Cataplexy	139.85	18.83	47	42660	1019	50561398
Sleep-related eating disorder	133.86	18.83	42	42665	726	50561691
Abnormal sleep-related event	132.99	18.83	41	42666	667	50561750
Post-traumatic stress disorder	131.99	18.83	67	42640	4236	50558181
Stress	126.21	18.83	189	42518	53604	50508813
Pyrexia	124.95	18.83	84	42623	380119	50182298
Hysterectomy	123.13	18.83	79	42628	7811	50554606
Diarrhoea	120.41	18.83	195	42512	588281	49974136
Suicide attempt	118.86	18.83	180	42527	51552	50510865
Irritability	112.12	18.83	129	42578	28297	50534120
Dizziness	110.71	18.83	580	42127	345789	50216628
Death	102.73	18.83	75	42632	325304	50237113
Hypertension	99.72	18.83	397	42310	210806	50351611
Wrong technique in product usage process	98.74	18.83	172	42535	55338	50507079
Memory impairment	98.35	18.83	211	42496	79149	50483268
Fibromyalgia	97.00	18.83	152	42555	44826	50517591
Joint swelling	96.74	18.83	43	42664	245243	50317174
Retching	94.73	18.83	82	42625	12780	50549637
Intervertebral disc protrusion	93.26	18.83	100	42607	20293	50542124
Lethargy	92.95	18.83	157	42550	49275	50513142
Substance use	90.72	18.83	26	42681	324	50562093
Thrombocytopenia	90.70	18.83	4	42703	127669	50434748
Haemoglobin decreased	90.33	18.83	4	42703	127212	50435205
Major depression	88.28	18.83	61	42646	6823	50555594
Anaemia	88.02	18.83	52	42655	252404	50310013
General physical health deterioration	88.02	18.83	9	42698	142425	50419992
Feeling jittery	88.01	18.83	74	42633	11086	50551331
Crying	87.93	18.83	97	42610	20319	50542098
Psychotic disorder	87.73	18.83	100	42607	21712	50540705
Narcolepsy	87.61	18.83	34	42673	1126	50561291
Bruxism	86.49	18.83	45	42662	2995	50559422
Pruritus	86.09	18.83	68	42639	283500	50278917
Contraindicated product administered	85.67	18.83	12	42695	148946	50413471
Disability	85.22	18.83	77	42630	12698	50549719
Hypnagogic hallucination	83.62	18.83	20	42687	114	50562303
White blood cell count decreased	81.79	18.83	4	42703	116718	50445699
Nephrolithiasis	80.07	18.83	121	42586	34572	50527845
Intentional product use issue	79.15	18.83	190	42517	76728	50485689
Road traffic accident	78.85	18.83	100	42607	24252	50538165
Drug diversion	78.21	18.83	28	42679	737	50561680
Toxicity to various agents	78.06	18.83	41	42666	212458	50349959
Sudden onset of sleep	75.95	18.83	25	42682	507	50561910
Illness	75.11	18.83	98	42609	24442	50537975
Glossodynia	74.90	18.83	6	42701	115563	50446854
Arthralgia	73.19	18.83	164	42543	438538	50123879
Sleep talking	72.70	18.83	28	42679	908	50561509
Drug intolerance	72.39	18.83	48	42659	219056	50343361
Back injury	70.84	18.83	54	42653	7031	50555386
Extra dose administered	69.89	18.83	47	42660	5029	50557388
Hyperhidrosis	69.60	18.83	199	42508	89227	50473190
Nausea	68.40	18.83	900	41807	704498	49857919
Paranoia	68.29	18.83	62	42645	10286	50552131
Disease progression	68.09	18.83	3	42704	95863	50466554
Pneumonia	67.65	18.83	136	42571	378265	50184152
Wound	67.16	18.83	6	42701	105788	50456629
Maternal exposure during pregnancy	66.18	18.83	26	42681	159752	50402665
Platelet count decreased	65.91	18.83	5	42702	100721	50461696
Gastrooesophageal reflux disease	65.32	18.83	176	42531	76252	50486165
Apnoea	65.09	18.83	51	42656	6915	50555502
Middle insomnia	64.60	18.83	59	42648	9862	50552555
Knee operation	64.42	18.83	44	42663	4829	50557588
Postural orthostatic tachycardia syndrome	63.88	18.83	25	42682	847	50561570
Therapeutic product effect decreased	63.57	18.83	18	42689	136032	50426385
Fall	63.30	18.83	491	42216	334441	50227976
Perinatal depression	62.93	18.83	22	42685	539	50561878
Product use in unapproved indication	62.80	18.83	11	42696	115808	50446609
Abdominal pain	61.72	18.83	65	42642	236163	50326254
Seizure	61.61	18.83	229	42478	117645	50444772
Sepsis	61.35	18.83	18	42689	132907	50429510
Hallucination	60.02	18.83	126	42581	46531	50515886
Alopecia	58.00	18.83	73	42634	244974	50317443
Impaired gastric emptying	57.07	18.83	52	42655	8666	50553751
Drug tolerance	56.64	18.83	41	42666	4935	50557482
Asthma exercise induced	56.17	18.83	17	42690	259	50562158
Infection	55.62	18.83	39	42668	172915	50389502
Erythema	55.61	18.83	27	42680	146387	50416030
Gastric bypass	54.73	18.83	26	42681	1422	50560995
Alcohol abuse	53.68	18.83	28	42679	1873	50560544
Pleural effusion	53.41	18.83	4	42703	81450	50480967
Hypotension	52.80	18.83	73	42634	235396	50327021
Completed suicide	52.13	18.83	23	42684	131866	50430551
Nightmare	51.98	18.83	66	42641	16020	50546397
Hospitalisation	51.70	18.83	150	42557	67787	50494630
Head injury	51.52	18.83	81	42626	23939	50538478
Blister	51.22	18.83	6	42701	85412	50477005
Foot fracture	50.56	18.83	73	42634	20018	50542399
Emotional disorder	50.55	18.83	56	42651	11780	50550637
Prescribed overdose	50.53	18.83	62	42645	14538	50547879
Shoulder operation	50.43	18.83	27	42680	1905	50560512
Periodic limb movement disorder	48.52	18.83	14	42693	179	50562238
Nasopharyngitis	47.62	18.83	302	42405	192625	50369792
Lower respiratory tract infection	47.53	18.83	11	42696	95190	50467227
Therapeutic product effect incomplete	46.84	18.83	10	42697	91505	50470912
Musculoskeletal stiffness	46.83	18.83	25	42682	128456	50433961
Alanine aminotransferase increased	46.59	18.83	9	42698	88350	50474067
Ankle fracture	45.35	18.83	61	42646	15661	50546756
Product preparation error	45.21	18.83	34	42673	4338	50558079
Endometriosis	45.07	18.83	33	42674	4042	50558375
Mobility decreased	44.65	18.83	7	42700	79941	50482476
Asthma	44.54	18.83	171	42536	89166	50473251
Stomatitis	44.47	18.83	15	42692	101329	50461088
Hyponatraemia	44.38	18.83	13	42694	96126	50466291
Gastrointestinal haemorrhage	44.34	18.83	5	42702	73316	50489101
Spinal operation	44.26	18.83	39	42668	6221	50556196
Pollakiuria	43.82	18.83	75	42632	23776	50538641
Dyspnoea	43.76	18.83	277	42430	547331	50015086
Generalised anxiety disorder	43.52	18.83	24	42683	1796	50560621
Acne	43.31	18.83	67	42640	19528	50542889
Essential tremor	43.12	18.83	19	42688	872	50561545
Choking	43.01	18.83	44	42663	8454	50553963
Tachyphrenia	42.95	18.83	21	42686	1224	50561193
Respiratory failure	42.70	18.83	12	42695	91169	50471248
Leukopenia	42.40	18.83	4	42703	67524	50494893
Attention deficit hyperactivity disorder	42.11	18.83	26	42681	2403	50560014
Asthenia	41.96	18.83	134	42573	318908	50243509
Cardiac failure	41.70	18.83	7	42700	76033	50486384
Hepatic enzyme increased	41.55	18.83	33	42674	137347	50425070
Renal failure	41.50	18.83	19	42688	106614	50455803
Cholecystectomy	41.44	18.83	45	42662	9258	50553159
Back disorder	41.43	18.83	45	42662	9260	50553157
Lyme disease	41.01	18.83	26	42681	2517	50559900
Exposure during pregnancy	40.80	18.83	206	42501	120809	50441608
Arthropathy	40.60	18.83	44	42663	157862	50404555
Vitamin D deficiency	40.40	18.83	49	42658	11353	50551064
Dry mouth	39.85	18.83	121	42586	56057	50506360
Thirst	39.76	18.83	47	42660	10603	50551814
Nervousness	39.50	18.83	78	42629	27573	50534844
Rheumatoid arthritis	39.46	18.83	69	42638	202481	50359936
Aspartate aminotransferase increased	38.95	18.83	9	42698	77989	50484428
Respiratory depression	38.37	18.83	49	42658	11961	50550456
Seborrhoea	37.86	18.83	14	42693	405	50562012
Sleep terror	36.88	18.83	16	42691	707	50561710
Delusion	36.76	18.83	45	42662	10524	50551893
Euphoric mood	36.40	18.83	29	42678	4026	50558391
Hallucination, auditory	36.23	18.83	45	42662	10683	50551734
Incorrect dose administered	35.96	18.83	106	42601	48308	50514109
Cystitis interstitial	35.89	18.83	19	42688	1310	50561107
Colonoscopy	35.39	18.83	19	42688	1348	50561069
Mental disorder	35.06	18.83	65	42642	21926	50540491
Ill-defined disorder	34.95	18.83	3	42704	54651	50507766
Victim of sexual abuse	34.89	18.83	14	42693	507	50561910
Obsessive-compulsive disorder	34.59	18.83	26	42681	3314	50559103
No adverse event	34.57	18.83	83	42624	33495	50528922
Hyperpathia	34.24	18.83	7	42700	16	50562401
Discomfort	34.09	18.83	25	42682	108355	50454062
Urticaria	33.41	18.83	36	42671	129525	50432892
Systemic lupus erythematosus	33.12	18.83	42	42665	140580	50421837
Muscle spasms	33.12	18.83	200	42507	125353	50437064
Disturbance in attention	33.09	18.83	78	42629	31108	50531309
Pain	33.06	18.83	321	42386	578582	49983835
Muscle twitching	33.04	18.83	52	42655	15379	50547038
Oedema peripheral	32.43	18.83	52	42655	157909	50404508
Concussion	32.42	18.83	36	42671	7592	50554825
Urinary tract infection	31.63	18.83	91	42616	223929	50338488
Ehlers-Danlos syndrome	31.41	18.83	9	42698	112	50562305
Rheumatoid factor positive	31.17	18.83	3	42704	49856	50512561
Victim of spousal abuse	30.59	18.83	6	42701	10	50562407
Sleep attacks	29.60	18.83	8	42699	79	50562338
Disorientation	29.58	18.83	81	42626	35403	50527014
Palpitations	29.16	18.83	157	42550	94349	50468068
Nasal septum deviation	29.01	18.83	16	42691	1197	50561220
Vertigo	28.99	18.83	103	42604	51729	50510688
Intentional product misuse	28.88	18.83	96	42611	46638	50515779
Swelling	28.79	18.83	81	42626	200791	50361626
Foot operation	28.74	18.83	29	42678	5481	50556936
Spinal fusion surgery	28.47	18.83	25	42682	3970	50558447
Muscle tightness	28.31	18.83	39	42668	10241	50552176
Hypokalaemia	28.06	18.83	20	42687	87972	50474445
Cardiac arrest	28.03	18.83	18	42689	83633	50478784
Nerve compression	27.97	18.83	33	42674	7429	50554988
Conduction disorder	27.89	18.83	16	42691	1292	50561125
Impaired healing	27.83	18.83	12	42695	69774	50492643
Abnormal behaviour	27.53	18.83	55	42652	19603	50542814
Blood creatinine increased	27.48	18.83	15	42692	76145	50486272
Hyperkalaemia	27.33	18.83	4	42703	48085	50514332
Obesity	27.26	18.83	50	42657	16725	50545692
Intervertebral disc degeneration	26.95	18.83	44	42663	13417	50549000
Temporomandibular joint syndrome	26.94	18.83	23	42684	3516	50558901
Agitation	26.44	18.83	102	42605	53282	50509135
Rapid eye movements sleep abnormal	26.43	18.83	8	42699	122	50562295
Wisdom teeth removal	26.39	18.83	11	42696	440	50561977
Hypopnoea	26.34	18.83	19	42688	2274	50560143
Inappropriate schedule of product administration	26.13	18.83	125	42582	71706	50490711
Product administration interrupted	25.79	18.83	14	42693	1015	50561402
Autonomic nervous system imbalance	25.67	18.83	19	42688	2366	50560051
Restlessness	25.67	18.83	62	42645	25111	50537306
Headache	25.66	18.83	583	42124	505952	50056465
Nocturia	25.62	18.83	30	42677	6700	50555717
Drug interaction	25.40	18.83	85	42622	199536	50362881
Night sweats	25.40	18.83	74	42633	33500	50528917
Wrong dose	25.14	18.83	13	42694	854	50561563
Polycystic ovaries	24.98	18.83	19	42688	2465	50559952
Joint injury	24.77	18.83	56	42651	21733	50540684
Victim of abuse	24.44	18.83	7	42700	87	50562330
Helicobacter infection	24.29	18.83	6	42701	49696	50512721
Social anxiety disorder	24.20	18.83	10	42697	391	50562026
Paraesthesia	24.14	18.83	179	42528	120064	50442353
Product taste abnormal	23.64	18.83	16	42691	1729	50560688
Moaning	23.58	18.83	12	42695	762	50561655
Dyspnoea exertional	23.51	18.83	7	42700	51226	50511191
Seizure like phenomena	23.42	18.83	13	42694	985	50561432
Autoimmune disorder	23.41	18.83	27	42680	5933	50556484
Carpal tunnel syndrome	23.34	18.83	47	42660	16846	50545571
Libido increased	23.33	18.83	14	42693	1229	50561188
Blood glucose increased	23.02	18.83	16	42691	71308	50491109
Seasonal allergy	22.92	18.83	43	42664	14633	50547784
Tooth extraction	22.87	18.83	33	42674	9042	50553375
Lung disorder	22.70	18.83	5	42702	44794	50517623
Seasonal affective disorder	22.62	18.83	8	42699	203	50562214
Metabolic acidosis	22.60	18.83	3	42704	38822	50523595
Liver function test abnormal	22.37	18.83	5	42702	44334	50518083
Dental operation	22.32	18.83	13	42694	1080	50561337
Autoimmune thyroiditis	22.30	18.83	20	42687	3265	50559152
Pulmonary embolism	22.29	18.83	32	42675	101672	50460745
Meniscus injury	22.19	18.83	27	42680	6275	50556142
Premenstrual dysphoric disorder	22.17	18.83	5	42702	21	50562396
Oxygen saturation decreased	21.63	18.83	18	42689	73230	50489187
Hypersomnia	21.63	18.83	43	42664	15271	50547146
Victim of crime	21.62	18.83	6	42701	66	50562351
Incoherent	21.58	18.83	22	42685	4208	50558209
Neck injury	21.51	18.83	15	42692	1702	50560715
Accident	21.40	18.83	24	42683	5117	50557300
Anger	21.29	18.83	36	42671	11297	50551120
Wheezing	21.27	18.83	13	42694	62034	50500383
Endodontic procedure	21.22	18.83	18	42689	2728	50559689
Influenza like illness	21.19	18.83	11	42696	57448	50504969
Rash pruritic	21.13	18.83	7	42700	47839	50514578
Ankle operation	20.93	18.83	13	42694	1214	50561203
Panic reaction	20.88	18.83	20	42687	3549	50558868
White blood cell count increased	20.84	18.83	5	42702	42235	50520182
Tonsillectomy	20.70	18.83	11	42696	764	50561653
Essential hypertension	20.68	18.83	22	42685	4422	50557995
Renal impairment	20.66	18.83	20	42687	75641	50486776
Metabolic surgery	20.50	18.83	12	42695	1006	50561411
Treatment noncompliance	20.50	18.83	64	42643	30086	50532331
Neuralgia	20.34	18.83	52	42655	21811	50540606
Blood pressure systolic increased	20.03	18.83	3	42704	35446	50526971
Confusional arousal	19.97	18.83	6	42701	89	50562328
White coat hypertension	19.87	18.83	9	42698	441	50561976
Dyskinesia	19.74	18.83	60	42647	27801	50534616
Procedural pain	19.73	18.83	39	42668	13793	50548624
Scoliosis	19.71	18.83	26	42681	6550	50555867
Post procedural complication	19.66	18.83	41	42666	15063	50547354
International normalised ratio increased	19.61	18.83	6	42701	43146	50519271
Rash erythematous	19.57	18.83	3	42704	34849	50527568
Pituitary tumour	19.57	18.83	11	42696	854	50561563
Hypnopompic hallucination	19.55	18.83	5	42702	39	50562378
Therapeutic product effect prolonged	19.55	18.83	8	42699	305	50562112
Gallbladder operation	19.48	18.83	15	42692	1982	50560435
Femur fracture	19.36	18.83	4	42703	37460	50524957
Upper airway resistance syndrome	19.31	18.83	4	42703	10	50562407
Urinary incontinence	19.29	18.83	60	42647	28148	50534269
Haematochezia	19.13	18.83	5	42702	39877	50522540
Electrocardiogram QT prolonged	19.03	18.83	10	42697	51876	50510541
Progesterone decreased	18.95	18.83	6	42701	107	50562310
Adjustment disorder with depressed mood	18.84	18.83	17	42690	2797	50559620

FDA Adverse Event Reporting System (Male)

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	708.85	25.27	283	14597	17316	29542331
Pre-existing condition improved	445.74	25.27	121	14759	2132	29557515
Product use issue	288.79	25.27	225	14655	51219	29508428
Depression	273.50	25.27	271	14609	84876	29474771
Suicidal ideation	272.40	25.27	186	14694	34530	29525117
Somnolence	242.43	25.27	266	14614	93689	29465958
Somnambulism	212.87	25.27	72	14808	2726	29556921
Feeling abnormal	192.76	25.27	183	14697	54262	29505385
Anxiety	188.36	25.27	223	14657	85142	29474505
Therapeutic response unexpected	154.65	25.27	79	14801	8559	29551088
Insomnia	143.82	25.27	199	14681	88562	29471085
Hunger	140.30	25.27	44	14836	1305	29558342
Unevaluable event	128.36	25.27	112	14768	29739	29529908
Enuresis	117.80	25.27	43	14837	2041	29557606
Sleep-related eating disorder	114.50	25.27	27	14853	259	29559388
Surgery	113.88	25.27	72	14808	11707	29547940
Blood pressure increased	109.88	25.27	159	14721	73644	29486003
Acute kidney injury	106.37	25.27	7	14873	265260	29294387
Condition aggravated	105.34	25.27	229	14651	146066	29413581
Initial insomnia	102.42	25.27	42	14838	2733	29556914
Bipolar disorder	92.24	25.27	41	14839	3254	29556393
Sleep paralysis	89.07	25.27	20	14860	151	29559496
Intervertebral disc protrusion	88.84	25.27	55	14825	8615	29551032
Hangover	85.70	25.27	28	14852	949	29558698
Wrong technique in product usage process	84.26	25.27	91	14789	31337	29528310
Snoring	82.32	25.27	36	14844	2748	29556899
Pyrexia	79.91	25.27	23	14857	287599	29272048
Hypertension	78.70	25.27	178	14702	116436	29443211
Feeling drunk	78.23	25.27	30	14850	1634	29558013
Poor quality sleep	76.95	25.27	47	14833	7186	29552461
Nephrolithiasis	76.18	25.27	78	14802	25256	29534391
Cataplexy	74.88	25.27	19	14861	253	29559394
Disability	72.16	25.27	38	14842	4378	29555269
Restless legs syndrome	70.78	25.27	44	14836	6940	29552707
Migraine	68.74	25.27	54	14826	12376	29547271
Anaemia	65.98	25.27	11	14869	200940	29358707
Shoulder operation	65.57	25.27	22	14858	811	29558836
Abnormal sleep-related event	65.16	25.27	19	14861	437	29559210
Post-traumatic stress disorder	64.83	25.27	26	14854	1596	29558051
Abnormal dreams	61.18	25.27	40	14840	6880	29552767
Narcolepsy	59.82	25.27	18	14862	463	29559184
Substance use	59.24	25.27	18	14862	479	29559168
Intentional product use issue	58.03	25.27	88	14792	42410	29517237
Middle insomnia	57.94	25.27	36	14844	5672	29553975
Weight decreased	57.90	25.27	187	14693	150718	29408929
Thrombocytopenia	55.62	25.27	3	14877	134820	29424827
Nasopharyngitis	54.19	25.27	103	14777	59562	29500085
Stress	53.71	25.27	60	14820	21430	29538217
Suicide attempt	51.41	25.27	74	14806	34036	29525611
Parasomnia	51.07	25.27	15	14865	354	29559293
No adverse event	51.06	25.27	53	14827	17425	29542222
Alcohol abuse	50.86	25.27	30	14850	4303	29555344
Pneumonia	50.70	25.27	52	14828	320120	29239527
Drug abuse	49.48	25.27	118	14762	79765	29479882
Rash	49.37	25.27	17	14863	189802	29369845
Irritability	47.24	25.27	57	14823	22095	29537552
Hypotension	44.68	25.27	21	14859	194333	29365314
Death	44.21	25.27	65	14815	342019	29217628
Intentional product misuse	43.43	25.27	69	14811	34592	29525055
Overdose	43.21	25.27	112	14768	79707	29479940
Drug diversion	43.04	25.27	16	14864	799	29558848
Hypnagogic hallucination	42.62	25.27	9	14871	49	29559598
Memory impairment	42.16	25.27	70	14810	36400	29523247
Haemoglobin decreased	40.16	25.27	4	14876	108371	29451276
Spinal operation	40.08	25.27	21	14859	2393	29557254
Road traffic accident	39.83	25.27	44	14836	15517	29544130
Head injury	38.65	25.27	44	14836	16037	29543610
Back injury	37.98	25.27	23	14857	3461	29556186
Tachyphrenia	37.45	25.27	16	14864	1153	29558494
Knee operation	37.02	25.27	17	14863	1455	29558192
Sepsis	36.69	25.27	13	14867	142669	29416978
Diarrhoea	36.69	25.27	70	14810	332628	29227019
Drug tolerance	36.52	25.27	19	14861	2134	29557513
Blood cholesterol increased	36.35	25.27	42	14838	15553	29544094
Sleep talking	36.09	25.27	12	14868	430	29559217
Wrong dose	35.57	25.27	12	14868	450	29559197
Lethargy	35.49	25.27	66	14814	37514	29522133
Spinal fusion surgery	35.29	25.27	14	14866	835	29558812
Product preparation error	35.05	25.27	17	14863	1645	29558002
Feeling jittery	34.58	25.27	22	14858	3611	29556036
Hospitalisation	34.10	25.27	73	14807	45915	29513732
Agitation	33.06	25.27	77	14803	51227	29508420
Confusional arousal	32.99	25.27	6	14874	12	29559635
Extra dose administered	32.73	25.27	20	14860	3057	29556590
Product use in unapproved indication	32.73	25.27	3	14877	86872	29472775
Nightmare	32.23	25.27	34	14846	11383	29548264
Renal failure	31.89	25.27	10	14870	118589	29441058
Foot operation	31.87	25.27	12	14868	621	29559026
Periodic limb movement disorder	31.56	25.27	8	14872	106	29559541
Incorrect dose administered	31.23	25.27	58	14822	32926	29526721
Food craving	31.18	25.27	10	14870	319	29559328
Panic attack	29.40	25.27	28	14852	8298	29551349
Concussion	28.94	25.27	16	14864	2030	29557617
Prescribed overdose	28.40	25.27	28	14852	8655	29550992
Hyperhidrosis	28.40	25.27	84	14796	64456	29495191
Headache	27.96	25.27	166	14714	173841	29385806
Fibromyalgia	27.74	25.27	17	14863	2612	29557035
Nasal septum deviation	27.05	25.27	12	14868	947	29558700
Gastrointestinal haemorrhage	26.85	25.27	4	14876	79529	29480118
Loss of consciousness	26.72	25.27	90	14790	73966	29485681
Moaning	26.46	25.27	11	14869	740	29558907
Abdominal pain	26.24	25.27	18	14862	135339	29424308
Fall	25.93	25.27	165	14715	177013	29382634

FDA Adverse Event Reporting System (Geriatric)

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	707.83	21.08	333	32927	29499	64435973
Somnolence	674.02	21.08	666	32594	202979	64262493
Feeling abnormal	494.17	21.08	465	32795	133137	64332335
Pre-existing condition improved	457.30	21.08	147	33113	4615	64460857
Anxiety	446.01	21.08	535	32725	202114	64263358
Somnambulism	442.22	21.08	146	33114	4995	64460477
Depression	374.06	21.08	466	32794	182825	64282647
Enuresis	334.24	21.08	102	33158	2688	64462784
Suicidal ideation	301.62	21.08	260	33000	66282	64399190
Initial insomnia	268.15	21.08	104	33156	5700	64459772
Feeling drunk	259.67	21.08	93	33167	4074	64461398
Insomnia	252.64	21.08	402	32858	197434	64268038
Unevaluable event	246.62	21.08	206	33054	50283	64415189
Hangover	225.58	21.08	69	33191	1832	64463640
Surgery	219.48	21.08	152	33108	28061	64437411
Poor quality sleep	219.02	21.08	131	33129	18820	64446652
Migraine	204.62	21.08	204	33056	62473	64402999
Acute kidney injury	204.51	21.08	6	33254	449234	64016238
Abnormal dreams	198.47	21.08	100	33160	10256	64455216
Condition aggravated	188.63	21.08	517	32743	371909	64093563
Lethargy	184.86	21.08	207	33053	72387	64393085
Suicide attempt	181.72	21.08	203	33057	70804	64394668
Sleep paralysis	172.61	21.08	43	33217	515	64464957
Snoring	164.82	21.08	69	33191	4613	64460859
Therapeutic response unexpected	157.21	21.08	102	33158	16899	64448573
Irritability	155.16	21.08	138	33122	36608	64428864
Weight decreased	154.89	21.08	407	32853	285332	64180140
Tremor	137.71	21.08	262	32998	147968	64317504
Dizziness	136.00	21.08	508	32752	429655	64035817
Hunger	133.83	21.08	58	33202	4223	64461249
Cataplexy	132.88	21.08	38	33222	793	64464679
Blood pressure increased	132.83	21.08	282	32978	172270	64293202
Product use issue	123.82	21.08	254	33006	151461	64314011
Panic attack	122.43	21.08	95	33165	20858	64444614
Bipolar disorder	117.12	21.08	61	33199	6700	64458772
Middle insomnia	115.97	21.08	76	33184	12801	64452671
Anaemia	111.39	21.08	29	33231	378651	64086821
Memory impairment	108.94	21.08	174	33086	85508	64379964
Abnormal sleep-related event	107.16	21.08	32	33228	781	64464691
Pyrexia	106.24	21.08	80	33180	558564	63906908
Sleep-related eating disorder	103.75	21.08	30	33230	652	64464820
Fall	95.31	21.08	446	32814	416380	64049092
Rash	93.28	21.08	61	33199	458488	64006984
Restless legs syndrome	92.24	21.08	74	33186	17042	64448430
Sleep talking	91.99	21.08	30	33230	985	64464487
Wrong technique in product usage process	91.02	21.08	138	33122	64836	64400636
Stress	88.26	21.08	131	33129	60403	64405069
Crying	87.88	21.08	77	33183	20013	64445459
Intervertebral disc protrusion	85.55	21.08	76	33184	20115	64445357
Hypnagogic hallucination	85.53	21.08	19	33241	132	64465340
Parasomnia	85.31	21.08	24	33236	471	64465001
Road traffic accident	83.96	21.08	91	33169	30654	64434818
Shoulder operation	83.70	21.08	34	33226	2104	64463368
Agitation	82.97	21.08	157	33103	88210	64377262
Nausea	82.64	21.08	688	32572	785112	63680360
Narcolepsy	81.98	21.08	28	33232	1063	64464409
Psychotic disorder	80.18	21.08	94	33166	34484	64430988
General physical health deterioration	79.58	21.08	7	33253	204418	64261054
Nightmare	79.13	21.08	74	33186	20919	64444553
Extra dose administered	78.85	21.08	47	33213	6703	64458769
Haemoglobin decreased	77.81	21.08	6	33254	195057	64270415
Head injury	77.35	21.08	90	33170	32752	64432720
Seizure	75.67	21.08	223	33037	166669	64298803
Hypotension	75.65	21.08	52	33208	380922	64084550
Back injury	75.30	21.08	48	33212	7709	64457763
Feeling jittery	75.02	21.08	54	33206	10581	64454891
Pneumonia	73.93	21.08	109	33151	559467	63906005
Nervousness	72.98	21.08	83	33177	29473	64435999
Incorrect dose administered	72.59	21.08	120	33140	60645	64404827
Hysterectomy	71.64	21.08	40	33220	5045	64460427
Platelet count decreased	70.29	21.08	4	33256	167707	64297765
Post-traumatic stress disorder	70.15	21.08	37	33223	4168	64461304
Product use in unapproved indication	68.87	21.08	6	33254	176612	64288860
Retching	67.78	21.08	59	33201	15197	64450275
Drug ineffective	67.64	21.08	216	33044	840031	63625441
Hallucination	66.68	21.08	128	33132	72660	64392812
Substance use	66.55	21.08	21	33239	619	64464853
White blood cell count decreased	65.43	21.08	4	33256	157833	64307639
Sudden onset of sleep	63.59	21.08	20	33240	583	64464889
Sepsis	63.30	21.08	20	33240	230321	64235151
Hyperhidrosis	60.53	21.08	171	33089	124749	64340723
Death	59.91	21.08	98	33162	482607	63982865
Diarrhoea	59.35	21.08	184	33076	722520	63742952
Headache	58.90	21.08	470	32790	528997	63936475
Joint swelling	58.65	21.08	19	33241	215363	64250109
Tachyphrenia	57.28	21.08	25	33235	1851	64463621
Hypertension	55.89	21.08	273	32987	258988	64206484
Spinal fusion surgery	54.95	21.08	30	33230	3621	64461851
Alcohol abuse	54.64	21.08	33	33227	4819	64460653
Alanine aminotransferase increased	53.45	21.08	5	33255	139026	64326446
Hallucination, auditory	53.14	21.08	54	33206	16885	64448587
Spinal operation	52.32	21.08	35	33225	6098	64459374
Disease progression	52.13	21.08	6	33254	141674	64323798
Pruritus	51.62	21.08	51	33209	312349	64153123
Respiratory depression	51.49	21.08	62	33198	23381	64442091
Knee operation	51.33	21.08	31	33229	4526	64460946
Paranoia	51.06	21.08	52	33208	16300	64449172
Confusional state	50.68	21.08	267	32993	260877	64204595
Renal failure	49.50	21.08	16	33244	181672	64283800
Fibromyalgia	48.76	21.08	75	33185	35656	64429816
Concussion	48.57	21.08	37	33223	7901	64457571
Abnormal behaviour	47.90	21.08	72	33188	33550	64431922
Delusion	45.17	21.08	51	33209	17963	64447509
Erythema	45.09	21.08	20	33240	187050	64278422
Pleural effusion	45.00	21.08	6	33254	126553	64338919
Disorientation	44.90	21.08	93	33167	55735	64409737
Procedural pain	44.26	21.08	47	33213	15461	64450011
Hyponatraemia	44.23	21.08	11	33249	148328	64317144
Conduction disorder	43.60	21.08	24	33236	2944	64462528
Loss of consciousness	43.17	21.08	171	33089	148194	64317278
Foot fracture	43.15	21.08	50	33210	18107	64447365
Wrong dose	42.71	21.08	18	33242	1223	64464249
Gastric bypass	42.14	21.08	17	33243	1033	64464439
Intentional product misuse	42.12	21.08	106	33154	72189	64393283
Aspartate aminotransferase increased	41.83	21.08	6	33254	119782	64345690
Vertigo	41.39	21.08	93	33167	58918	64406554
Pollakiuria	41.37	21.08	65	33195	31465	64434007
Contraindicated product administered	41.12	21.08	4	33256	107825	64357647
Emotional disorder	41.03	21.08	41	33219	12566	64452906
Foot operation	40.59	21.08	26	33234	4209	64461263
No adverse event	40.45	21.08	61	33199	28500	64436972
Overdose	40.23	21.08	176	33084	159390	64306082
Completed suicide	40.18	21.08	34	33226	224380	64241092
Sleep terror	39.99	21.08	17	33243	1180	64464292
Renal impairment	38.38	21.08	11	33249	135006	64330466
Cardiac arrest	37.87	21.08	16	33244	154048	64311424
Muscle spasms	37.43	21.08	158	33102	140865	64324607
Abdominal pain	37.23	21.08	65	33195	312310	64153162
Inappropriate schedule of product administration	36.82	21.08	118	33142	92168	64373304
Respiratory failure	36.14	21.08	19	33241	161164	64304308
Apnoea	35.97	21.08	35	33225	10387	64455085
Infection	35.63	21.08	26	33234	184854	64280618
Dry mouth	35.62	21.08	89	33171	60329	64405143
Hyperkalaemia	35.46	21.08	5	33255	101124	64364348
Cardiac failure	35.45	21.08	12	33248	132361	64333111
Anger	35.17	21.08	42	33218	15699	64449773
Muscle twitching	34.96	21.08	46	33214	18952	64446520
Paraesthesia	34.38	21.08	149	33111	134373	64331099
Nasopharyngitis	33.66	21.08	194	33066	195879	64269593
Victim of spousal abuse	33.54	21.08	6	33254	10	64465462
Drug intolerance	33.01	21.08	29	33231	187963	64277509
Moaning	32.52	21.08	14	33246	1002	64464470
Therapeutic product effect incomplete	32.18	21.08	7	33253	103475	64361997
Product preparation error	32.12	21.08	22	33238	3983	64461489
Medication error	32.01	21.08	76	33184	49890	64415582
Intentional product use issue	31.94	21.08	115	33145	95249	64370223
Lower limb fracture	31.68	21.08	37	33223	13508	64451964
Bruxism	31.68	21.08	21	33239	3603	64461869
Product taste abnormal	31.65	21.08	17	33243	1986	64463486
Disturbance in attention	31.37	21.08	67	33193	41007	64424465
Drug diversion	31.02	21.08	14	33246	1122	64464350
Nephrolithiasis	30.80	21.08	69	33191	43614	64421858
Accidental poisoning	30.70	21.08	15	33245	1438	64464034
Euphoric mood	30.31	21.08	26	33234	6565	64458907
Palpitations	30.03	21.08	120	33140	104368	64361104
Cardio-respiratory arrest	29.90	21.08	7	33253	98386	64367086
Cholecystectomy	29.66	21.08	28	33232	8004	64457468
Coma	29.63	21.08	106	33154	87509	64377963
Amnesia	29.40	21.08	72	33188	48197	64417275
Restlessness	29.36	21.08	64	33196	39721	64425751
Ankle operation	29.30	21.08	13	33247	1001	64464471
Rheumatoid arthritis	29.26	21.08	25	33235	164269	64301203
Night sweats	28.92	21.08	60	33200	35986	64429486
Periodic limb movement disorder	28.73	21.08	8	33252	151	64465321
Urinary tract infection	28.68	21.08	47	33213	231549	64233923
Mental disorder	28.62	21.08	50	33210	26395	64439077
Urticaria	28.01	21.08	21	33239	147296	64318176
Drug tolerance	27.97	21.08	24	33236	6061	64459411
Hypokalaemia	27.87	21.08	14	33246	121889	64343583
Ankle fracture	27.66	21.08	36	33224	14674	64450798
Blood creatinine increased	27.61	21.08	18	33242	135764	64329708
Dyspnoea exertional	27.42	21.08	3	33257	73727	64391745
Panic reaction	27.38	21.08	20	33240	4007	64461465
Thirst	27.21	21.08	35	33225	14102	64451370
Muscle tightness	27.07	21.08	31	33229	11084	64454388
Arthralgia	26.87	21.08	127	33133	442133	64023339
Gastrooesophageal reflux disease	26.77	21.08	99	33161	83044	64382428
Choking	26.70	21.08	30	33230	10508	64454964
Incoherent	26.64	21.08	25	33235	7093	64458379
Endometriosis	26.41	21.08	17	33243	2775	64462697
Hypersomnia	26.35	21.08	41	33219	19676	64445796
Lower respiratory tract infection	26.35	21.08	8	33252	94606	64370866
Mobility decreased	26.30	21.08	6	33254	85834	64379638
Metabolic acidosis	26.10	21.08	3	33257	70955	64394517
Thinking abnormal	26.09	21.08	31	33229	11525	64453947
Oedema peripheral	25.74	21.08	43	33217	210274	64255198
Drug interaction	25.66	21.08	98	33162	361985	64103487
Drug withdrawal syndrome	25.01	21.08	52	33208	31239	64434233
Dyspnoea	24.86	21.08	244	33016	718430	63747042
Confusional arousal	24.47	21.08	6	33254	67	64465405
Stomatitis	24.44	21.08	13	33247	109592	64355880
Joint injury	24.33	21.08	43	33217	22904	64442568
Dyskinesia	24.25	21.08	59	33201	39329	64426143
Seasonal affective disorder	24.21	21.08	7	33253	152	64465320
Blister	24.13	21.08	6	33254	80961	64384511
Psoriasis	24.10	21.08	4	33256	71699	64393773
Attention deficit hyperactivity disorder	24.09	21.08	16	33244	2754	64462718
Therapy non-responder	23.72	21.08	3	33257	65896	64399576
Unresponsive to stimuli	23.43	21.08	68	33192	50325	64415147
Inappropriate affect	23.40	21.08	12	33248	1276	64464196
Drug abuse	23.37	21.08	132	33128	132242	64333230
Rotator cuff syndrome	23.34	21.08	30	33230	12077	64453395
Sedation	23.32	21.08	60	33200	41402	64424070
Seizure like phenomena	23.28	21.08	13	33247	1639	64463833
Sleep attacks	23.20	21.08	7	33253	177	64465295
Essential tremor	23.13	21.08	12	33248	1307	64464165
Gallbladder operation	22.90	21.08	13	33247	1692	64463780
Hepatic enzyme increased	22.86	21.08	20	33240	129923	64335549
Major depression	22.86	21.08	24	33236	7792	64457680
Hormone level abnormal	22.81	21.08	13	33247	1704	64463768
Wound	22.16	21.08	6	33254	76471	64389001
Hypopnoea	22.03	21.08	16	33244	3178	64462294
Investigation	22.02	21.08	14	33246	2238	64463234
Nerve compression	21.98	21.08	23	33237	7438	64458034
Wisdom teeth removal	21.89	21.08	8	33252	371	64465101
Seborrhoea	21.77	21.08	8	33252	377	64465095
Knee arthroplasty	21.73	21.08	45	33215	26954	64438518
Disability	21.67	21.08	29	33231	12143	64453329
International normalised ratio increased	21.50	21.08	7	33253	79160	64386312
Prescribed overdose	21.43	21.08	38	33222	20293	64445179
Ear infection	21.22	21.08	41	33219	23363	64442109

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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
MeSH PA	D000759	Adjuvants, Anesthesia
MeSH PA	D000777	Anesthetics
MeSH PA	D018686	Anesthetics, Intravenous
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
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

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

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
Substance abuse	contraindication	66214007
Incontinence of feces	contraindication	72042002
Sleep apnea	contraindication	73430006	DOID:0050847
Sleep walking disorder	contraindication	80495009
Decreased respiratory function	contraindication	80954004
Seizure disorder	contraindication	128613002
Urinary incontinence	contraindication	165232002
Disease of liver	contraindication	235856003	DOID:409
Impaired cognition	contraindication	386806002
Chronic lung disease	contraindication	413839001
Psychiatric Disturbance	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	8731963	Dec. 17, 2022	METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	XYWAV	JAZZ	N212690	July 21, 2020	RX	SOLUTION	ORAL	8731963	Dec. 17, 2022	METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	7668730	June 16, 2024	METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
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
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	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
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	10864181	March 15, 2033	METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	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
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	11253494	March 15, 2033	METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	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.
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	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.
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	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	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.

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.5GM/ML	XYREM	JAZZ PHARMS	N021196	July 17, 2002	RX	SOLUTION	ORAL	April 26, 2022	PEDIATRIC EXCLUSIVITY
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
0.5GM/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
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

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
GABA-B receptor	GPCR	O75899 Q9UBS5	GABR2_HUMAN GABR1_HUMAN	AGONIST				CHEMBL	CHEMBL
Gamma-hydroxybutyrate receptor	Unclassified		Q6RY99_RAT		IC50	5.18		CHEMBL

External reference:

ID	Source
D05866	KEGG_DRUG
4021348	VUID
N0000148768	NUI
4021348	VANDF
CHEBI:30830	CHEBI
CHEMBL1200682	ChEMBL_ID
CHEMBL1342	ChEMBL_ID
591-81-1	SECONDARY_CAS_RN
DB09072	DRUGBANK_ID
7G33012534	UNII
10413	PUBCHEM_CID
DB01440	DRUGBANK_ID
1546380	RXNORM
16840	MMSL
44375	MMSL
d04806	MMSL
006073	NDDF
006074	NDDF
259470008	SNOMEDCT_US
386029006	SNOMEDCT_US
410917003	SNOMEDCT_US
782570005	SNOMEDCT_US
785621006	SNOMEDCT_US
D012978	MESH_DESCRIPTOR_UI
C0037537	UMLSCUI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
XYWAV	HUMAN PRESCRIPTION DRUG LABEL	4	68727-150	SOLUTION	0.50 g	ORAL	NDA	31 sections
XYWAV	HUMAN PRESCRIPTION DRUG LABEL	4	68727-150	SOLUTION	0.50 g	ORAL	NDA	31 sections