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)

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
Unevaluable event	454.12	18.57	349	48103	51037	63389533
Enuresis	442.50	18.57	136	48316	2437	63438133
Therapeutic response unexpected	437.40	18.57	235	48217	18524	63422046
Snoring	350.97	18.57	129	48323	4073	63436497
Migraine	300.48	18.57	382	48070	102964	63337606
Initial insomnia	273.66	18.57	120	48332	6037	63434533
Weight decreased	265.99	18.57	625	47827	276173	63164397
Blood pressure increased	244.39	18.57	441	48011	161621	63278949
Feeling drunk	228.13	18.57	94	48358	4048	63436522
Bipolar disorder	223.52	18.57	113	48339	7847	63432723
Panic attack	222.33	18.57	163	48289	22168	63418402
Hangover	221.24	18.57	72	48380	1564	63439006
Insomnia	220.87	18.57	499	47953	214753	63225817
Poor quality sleep	197.30	18.57	145	48307	19790	63420780
Parasomnia	190.00	18.57	50	48402	494	63440076
Sleep paralysis	189.66	18.57	52	48400	608	63439962
Abnormal dreams	180.88	18.57	108	48344	10408	63430162
Tremor	175.71	18.57	341	48111	131898	63308672
Restless legs syndrome	174.90	18.57	131	48321	18400	63422170
Rash	172.37	18.57	108	48344	560763	62879807
Hunger	170.72	18.57	83	48369	5296	63435274
Drug ineffective	164.60	18.57	346	48106	1044419	62396151
Acute kidney injury	164.45	18.57	9	48443	263406	63177164
Post-traumatic stress disorder	160.59	18.57	79	48373	5172	63435398
Sleep-related eating disorder	159.21	18.57	48	48404	803	63439767
Hysterectomy	151.63	18.57	93	48359	9406	63431164
Condition aggravated	148.14	18.57	653	47799	401564	63039006
Cataplexy	144.76	18.57	49	48403	1207	63439363
Pyrexia	143.89	18.57	91	48361	470387	62970183
Abnormal sleep-related event	140.95	18.57	43	48409	750	63439820
Stress	133.45	18.57	207	48245	66960	63373610
Major depression	131.83	18.57	80	48372	7938	63432632
Diarrhoea	130.79	18.57	216	48236	715150	62725420
Suicide attempt	129.87	18.57	194	48258	60724	63379846
Joint swelling	124.92	18.57	47	48405	327619	63112951
Irritability	124.90	18.57	137	48315	31557	63409013
General physical health deterioration	119.38	18.57	9	48443	201393	63239177
Neutropenia	119.35	18.57	3	48449	175002	63265568
Wrong technique in product usage process	118.12	18.57	188	48264	62152	63378418
Hypertension	115.48	18.57	470	47982	278833	63161737
Narcolepsy	110.26	18.57	41	48411	1337	63439233
Bruxism	107.69	18.57	53	48399	3472	63437098
Intervertebral disc protrusion	106.72	18.57	110	48342	23599	63416971
Product use issue	106.58	18.57	390	48062	220130	63220440
Glossodynia	105.99	18.57	8	48444	178868	63261702
Contraindicated product administered	103.98	18.57	20	48432	217628	63222942
Dizziness	103.56	18.57	620	47832	429305	63011265
Retching	102.77	18.57	87	48365	14558	63426012
Drug intolerance	100.89	18.57	55	48397	308606	63131964
Death	100.54	18.57	83	48369	374298	63066272
Psychotic disorder	99.33	18.57	110	48342	25602	63414968
Nephrolithiasis	98.61	18.57	140	48312	41844	63398726
Perinatal depression	98.15	18.57	32	48420	699	63439871
Product use in unapproved indication	95.64	18.57	12	48440	179068	63261502
Lethargy	94.08	18.57	160	48292	55847	63384723
Haemoglobin decreased	93.85	18.57	4	48448	145481	63295089
Crying	92.13	18.57	101	48351	23242	63417328
Thrombocytopenia	91.74	18.57	6	48446	151151	63289419
Disability	91.52	18.57	90	48362	18257	63422313
Substance use	91.22	18.57	28	48424	499	63440071
Pruritus	91.16	18.57	85	48367	361368	63079202
Postural orthostatic tachycardia syndrome	91.01	18.57	35	48417	1254	63439316
Feeling jittery	90.74	18.57	78	48374	13325	63427245
Wound	89.51	18.57	10	48442	163253	63277317
White blood cell count decreased	89.15	18.57	4	48448	139100	63301470
Memory impairment	88.68	18.57	225	48227	104033	63336537
Maternal exposure during pregnancy	88.21	18.57	29	48423	220033	63220537
Hypnagogic hallucination	87.62	18.57	22	48430	177	63440393
Seizure	86.76	18.57	260	48192	132374	63308196
Drug diversion	86.22	18.57	31	48421	917	63439653
Fall	85.75	18.57	552	47900	391782	63048788
Arthralgia	84.02	18.57	195	48257	569515	62871055
Hospitalisation	82.35	18.57	193	48259	84888	63355682
Gastrooesophageal reflux disease	81.96	18.57	207	48245	95432	63345138
Therapeutic product effect decreased	81.86	18.57	23	48429	193164	63247406
Road traffic accident	81.41	18.57	119	48333	36513	63404057
Sleep talking	81.03	18.57	30	48422	966	63439604
Illness	80.88	18.57	139	48313	48920	63391650
Paranoia	79.13	18.57	68	48384	11611	63428959
Sudden onset of sleep	77.47	18.57	25	48427	528	63440042
Disease progression	77.15	18.57	4	48448	122754	63317816
Toxicity to various agents	76.57	18.57	47	48405	247203	63193367
Alopecia	76.46	18.57	87	48365	337449	63103121
Anaemia	76.34	18.57	67	48385	293363	63147207
Blister	76.33	18.57	6	48446	129808	63310762
Hyperhidrosis	74.91	18.57	216	48236	107620	63332950
Intentional product use issue	74.66	18.57	241	48211	127651	63312919
Apnoea	71.90	18.57	55	48397	7967	63432603
Back injury	71.11	18.57	59	48393	9601	63430969
Nausea	69.97	18.57	974	47478	853497	62587073
Abdominal pain	69.36	18.57	73	48379	293383	63147187
Platelet count decreased	69.32	18.57	5	48447	116117	63324453
Knee operation	69.29	18.57	48	48404	5965	63434605
Victim of sexual abuse	68.40	18.57	24	48428	660	63439910
Pneumonia	68.35	18.57	155	48297	456612	62983958
Periodic limb movement disorder	68.32	18.57	19	48433	235	63440335
Musculoskeletal stiffness	67.78	18.57	28	48424	184590	63255980
Extra dose administered	66.93	18.57	48	48404	6302	63434268
Gastric bypass	66.72	18.57	31	48421	1786	63438784
Infection	66.30	18.57	47	48405	229126	63211444
Lower respiratory tract infection	65.67	18.57	11	48441	132296	63308274
Impaired gastric emptying	65.65	18.57	58	48394	10274	63430296
Nightmare	65.47	18.57	77	48375	19117	63421453
Mobility decreased	64.96	18.57	8	48444	121151	63319419
Ankle fracture	64.88	18.57	74	48378	17781	63422789
Attention deficit hyperactivity disorder	64.65	18.57	36	48416	3040	63437530
Arthropathy	64.27	18.57	51	48401	234741	63205829
Asthma exercise induced	64.10	18.57	19	48433	299	63440271
Head injury	63.80	18.57	91	48361	27305	63413265
Therapeutic product effect incomplete	62.95	18.57	10	48442	125046	63315524
Hallucination	62.75	18.57	133	48319	54684	63385886
Fibromyalgia	62.67	18.57	168	48284	80252	63360318
Endometriosis	62.56	18.57	43	48409	5277	63435293
Vitamin D deficiency	61.69	18.57	64	48388	13828	63426742
Stomatitis	61.64	18.57	15	48437	138710	63301860
Erythema	60.83	18.57	29	48423	175722	63264848
Discomfort	60.45	18.57	26	48426	167348	63273222
Middle insomnia	59.33	18.57	60	48392	12583	63427987
Alcohol abuse	58.88	18.57	30	48422	2116	63438454
Generalised anxiety disorder	56.93	18.57	29	48423	2045	63438525
Foot fracture	56.52	18.57	80	48372	23834	63416736
Cholecystectomy	56.29	18.57	54	48398	10623	63429947
Spinal operation	55.71	18.57	48	48404	8223	63432347
Pleural effusion	55.67	18.57	4	48448	93206	63347364
Lyme disease	55.63	18.57	34	48418	3415	63437155
Obsessive-compulsive disorder	55.40	18.57	36	48416	4024	63436546
Systemic lupus erythematosus	55.16	18.57	47	48405	208871	63231699
Sepsis	54.96	18.57	24	48428	153099	63287471
Drug tolerance	54.42	18.57	44	48408	6905	63433665
Emotional disorder	52.98	18.57	58	48394	13321	63427249
Product preparation error	52.92	18.57	41	48411	6051	63434519
Hepatic enzyme increased	52.83	18.57	46	48406	202282	63238288
Rheumatoid factor positive	52.25	18.57	3	48449	84403	63356167
Completed suicide	52.01	18.57	23	48429	145650	63294920
Alanine aminotransferase increased	50.67	18.57	9	48443	103761	63336809
Shoulder operation	50.45	18.57	28	48424	2349	63438221
Ill-defined disorder	50.32	18.57	3	48449	81752	63358818
Helicobacter infection	50.04	18.57	6	48446	92779	63347791
Exposure during pregnancy	49.95	18.57	243	48209	155304	63285266
Pollakiuria	49.82	18.57	82	48370	27855	63412715
Acne	49.35	18.57	74	48378	23219	63417351
Intentional dose omission	48.67	18.57	44	48408	8031	63432539
Hypotension	48.02	18.57	84	48368	272520	63168050
Essential tremor	47.67	18.57	21	48431	1067	63439503
Choking	46.57	18.57	47	48405	9832	63430738
Asthenia	46.10	18.57	145	48307	383459	63057111
Therapy non-responder	46.07	18.57	3	48449	75898	63364672
Pain	46.04	18.57	354	48098	740274	62700296
Tachyphrenia	46.01	18.57	22	48430	1352	63439218
Muscle spasms	45.95	18.57	238	48214	155912	63284658
Cardiac failure	45.15	18.57	7	48445	89135	63351435
Dyspnoea	44.99	18.57	308	48144	661005	62779565
Gastrointestinal haemorrhage	44.40	18.57	5	48447	81171	63359399
Nervousness	43.66	18.57	82	48370	30897	63409673
Concussion	43.61	18.57	44	48408	9200	63431370
Mental disorder	43.45	18.57	74	48378	25845	63414725
Respiratory failure	43.36	18.57	12	48440	101846	63338724
Hallucination, auditory	43.00	18.57	51	48401	12773	63427797
Cystitis interstitial	42.73	18.57	22	48430	1586	63438984
Hyponatraemia	42.65	18.57	16	48436	111884	63328686
Back disorder	42.31	18.57	47	48405	10970	63429600
Impaired healing	41.96	18.57	13	48439	102529	63338041
Respiratory depression	41.84	18.57	52	48400	13663	63426907
Leukopenia	41.68	18.57	5	48447	77285	63363285
Aspartate aminotransferase increased	41.61	18.57	9	48443	90268	63350302
Swelling	41.48	18.57	93	48359	275285	63165285
Ehlers-Danlos syndrome	41.01	18.57	12	48440	180	63440390
Nocturia	40.72	18.57	40	48412	8101	63432469
Rheumatoid arthritis	40.49	18.57	83	48369	253736	63186834
Asthma	39.32	18.57	197	48255	127364	63313206
Thirst	39.30	18.57	51	48401	13990	63426580
Delusion	38.99	18.57	47	48405	11970	63428600
Incorrect dose administered	38.64	18.57	117	48335	59851	63380719
Dry mouth	37.76	18.57	138	48314	77725	63362845
Treatment noncompliance	37.55	18.57	86	48366	37239	63403331
Palpitations	37.51	18.57	178	48274	112592	63327978
Seborrhoea	37.29	18.57	14	48438	469	63440101
Autoimmune thyroiditis	37.20	18.57	28	48424	3958	63436612
Nerve compression	37.04	18.57	40	48412	9047	63431523
Abnormal behaviour	37.01	18.57	62	48390	21364	63419206
Renal failure	36.89	18.57	22	48430	117630	63322940
Vertigo	36.87	18.57	115	48337	59772	63380798
Victim of chemical submission	35.97	18.57	14	48438	518	63440052
Wrong dose	35.93	18.57	18	48434	1225	63439345
Gastrectomy	35.60	18.57	15	48437	683	63439887
Essential hypertension	35.51	18.57	30	48422	5003	63435567
Hyperpathia	34.94	18.57	7	48445	16	63440554
Colonoscopy	34.53	18.57	19	48433	1567	63439003
Muscle tightness	34.52	18.57	44	48408	11856	63428714
Anger	34.48	18.57	45	48407	12411	63428159
Euphoric mood	34.22	18.57	29	48423	4858	63435712
Autonomic nervous system imbalance	33.66	18.57	23	48429	2795	63437775
No adverse event	32.74	18.57	87	48365	41318	63399252
Wheezing	32.71	18.57	16	48436	95579	63344991
Folliculitis	32.43	18.57	7	48445	70310	63370260
Liver injury	32.42	18.57	4	48448	60516	63380054
Disorientation	32.32	18.57	84	48368	39368	63401202
Temporomandibular joint syndrome	32.25	18.57	26	48426	4063	63436507
Urticaria	32.07	18.57	48	48404	165754	63274816
Disturbance in attention	32.00	18.57	82	48370	38107	63402463
Intervertebral disc degeneration	31.94	18.57	49	48403	15683	63424887
Nasopharyngitis	31.81	18.57	315	48137	253942	63186628
Foot operation	31.54	18.57	33	48419	7198	63433372
Victim of spousal abuse	31.20	18.57	6	48446	10	63440560
Oedema peripheral	31.04	18.57	61	48391	189450	63251120
Agitation	30.76	18.57	108	48344	59649	63380921
Carpal tunnel syndrome	30.46	18.57	56	48396	20761	63419809
Conduction disorder	30.37	18.57	17	48435	1450	63439120
Polycystic ovaries	30.22	18.57	26	48426	4445	63436125
Muscle twitching	30.16	18.57	54	48398	19614	63420956
Sleep attacks	30.04	18.57	8	48444	83	63440487
Metabolic surgery	29.86	18.57	16	48436	1252	63439318
Tooth extraction	29.85	18.57	38	48414	10226	63430344
Rapid eye movements sleep abnormal	29.82	18.57	9	48443	151	63440419
Nasal septum deviation	29.64	18.57	17	48435	1519	63439051
Blood creatinine increased	29.61	18.57	15	48437	87829	63352741
Hypothyroidism	29.19	18.57	85	48367	42547	63398023
Victim of abuse	28.83	18.57	8	48444	98	63440472
Spinal fusion surgery	28.79	18.57	28	48424	5600	63434970
Rotator cuff syndrome	28.75	18.57	43	48409	13459	63427111
Neuralgia	28.62	18.57	62	48390	25864	63414706
Headache	28.36	18.57	657	47795	632584	62807986
Wisdom teeth removal	28.14	18.57	12	48440	563	63440007
Cardiac arrest	28.05	18.57	18	48434	92527	63348043
Premenstrual dysphoric disorder	27.59	18.57	7	48445	59	63440511
Product taste abnormal	27.40	18.57	18	48434	2049	63438521
Lung disorder	27.13	18.57	7	48445	62254	63378316
Urinary tract infection	27.10	18.57	107	48345	264577	63175993
Neck injury	26.98	18.57	18	48434	2103	63438467
Moaning	26.68	18.57	13	48439	833	63439737
Neck surgery	26.63	18.57	17	48435	1843	63438727
Endodontic procedure	26.59	18.57	21	48431	3186	63437384
Seizure like phenomena	26.49	18.57	14	48438	1065	63439505
Tonsillectomy	26.26	18.57	13	48439	862	63439708
Seasonal affective disorder	26.25	18.57	10	48442	349	63440221
Scoliosis	25.83	18.57	31	48421	7857	63432713
Hyperkalaemia	25.81	18.57	5	48447	54198	63386372
Blood pressure systolic increased	25.71	18.57	3	48449	47394	63393176
Hypersomnia	25.70	18.57	48	48404	18007	63422563
Restlessness	25.46	18.57	64	48388	29389	63411181
Hypopnoea	25.45	18.57	22	48430	3784	63436786
Oral surgery	24.73	18.57	14	48438	1220	63439350
Social anxiety disorder	24.48	18.57	10	48442	421	63440149
Hypokalaemia	24.28	18.57	26	48426	103778	63336792
Prescribed overdose	24.26	18.57	69	48383	34084	63406486
Borderline personality disorder	24.20	18.57	12	48440	799	63439771
Ankle operation	24.18	18.57	14	48438	1273	63439297
Incoherent	24.05	18.57	23	48429	4507	63436063
Mast cell activation syndrome	24.00	18.57	12	48440	813	63439757
Obesity	23.75	18.57	63	48389	29889	63410681
Dental operation	23.67	18.57	14	48438	1325	63439245
Psoriatic arthropathy	23.63	18.57	21	48431	91499	63349071
Accident	23.62	18.57	26	48426	6006	63434564
Libido increased	23.61	18.57	14	48438	1331	63439239
Abdominal discomfort	23.48	18.57	146	48306	320739	63119831
Meniscus injury	23.37	18.57	28	48424	7086	63433484
Sleep terror	23.20	18.57	18	48434	2662	63437908
Blood glucose increased	23.13	18.57	18	48434	83738	63356832
Dyskinesia	23.07	18.57	65	48387	31937	63408633
Urinary incontinence	23.05	18.57	65	48387	31949	63408621
Seasonal allergy	23.01	18.57	50	48402	20900	63419670
Musculoskeletal pain	22.85	18.57	22	48430	92255	63348315
Migraine with aura	22.84	18.57	18	48434	2722	63437848
Mitral valve prolapse	22.76	18.57	17	48435	2376	63438194
Victim of crime	22.74	18.57	7	48445	126	63440444
Drug interaction	22.58	18.57	94	48358	229037	63211533
Loss of consciousness	22.58	18.57	161	48291	117960	63322610
Pituitary tumour	22.43	18.57	12	48440	936	63439634
Intentional product misuse	22.35	18.57	99	48353	60818	63379752
Rash erythematous	22.31	18.57	3	48449	42507	63398063
Oxygen saturation decreased	22.07	18.57	21	48431	88564	63352006
Rash pruritic	22.04	18.57	9	48443	59790	63380780
Face injury	22.01	18.57	19	48433	3263	63437307
Liver function test abnormal	21.80	18.57	5	48447	48176	63392394
Metabolic acidosis	21.80	18.57	4	48448	45065	63395505
Pain in extremity	21.66	18.57	156	48296	331330	63109240
Liver disorder	21.62	18.57	7	48445	53680	63386890
Haematochezia	21.52	18.57	7	48445	53537	63387033
Paraesthesia	21.35	18.57	198	48254	156768	63283802
Food craving	21.33	18.57	14	48438	1592	63438978
Joint injury	21.25	18.57	60	48392	29512	63411058
Blood testosterone increased	21.05	18.57	7	48445	163	63440407
Red blood cell count decreased	21.02	18.57	3	48449	40642	63399928
Cartilage injury	20.96	18.57	15	48437	1962	63438608
Gallbladder operation	20.85	18.57	16	48436	2327	63438243
Blood sodium increased	20.76	18.57	17	48435	2715	63437855
Mood altered	20.74	18.57	39	48413	14704	63425866
Therapeutic procedure	20.57	18.57	11	48441	857	63439713
Skin exfoliation	20.47	18.57	4	48448	43098	63397472
Pulmonary embolism	20.47	18.57	36	48416	116648	63323922
Blood alkaline phosphatase increased	20.38	18.57	4	48448	42963	63397607
Drug withdrawal syndrome	20.35	18.57	56	48396	27138	63413432
Electrocardiogram QT prolonged	20.31	18.57	10	48442	59520	63381050
Post procedural complication	20.20	18.57	42	48410	17032	63423538
Withdrawal syndrome	20.03	18.57	46	48406	19951	63420619
Rapid eye movement sleep behaviour disorder	20.01	18.57	8	48444	318	63440252
Panic reaction	19.93	18.57	20	48432	4154	63436416
Affective disorder	19.88	18.57	24	48428	6122	63434448
White coat hypertension	19.80	18.57	10	48442	692	63439878
Upper airway resistance syndrome	19.71	18.57	4	48448	10	63440560
Motion sickness	19.42	18.57	11	48441	960	63439610
Dyspnoea exertional	19.29	18.57	11	48441	60291	63380279
Therapeutic product effect prolonged	19.27	18.57	8	48444	351	63440219
Progesterone decreased	19.19	18.57	6	48446	114	63440456
Delayed sleep phase	19.18	18.57	4	48448	12	63440558
Hypersensitivity	18.99	18.57	138	48314	292547	63148023
Influenza like illness	18.91	18.57	14	48438	66810	63373760
International normalised ratio increased	18.78	18.57	6	48446	46419	63394151
Body temperature increased	18.65	18.57	3	48449	37189	63403381
Hypertonic bladder	18.64	18.57	18	48434	3570	63437000
Complex regional pain syndrome	18.62	18.57	15	48437	2342	63438228
Hepatic function abnormal	18.61	18.57	3	48449	37139	63403431

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	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
Therapeutic response unexpected	162.34	24.84	84	16913	9673	34930261
Unevaluable event	137.09	24.84	119	16878	32471	34907463
Hunger	136.97	24.84	45	16952	1609	34938325
Insomnia	133.35	24.84	205	16792	103702	34836232
Blood pressure increased	132.03	24.84	187	16810	87915	34852019
Surgery	130.70	24.84	83	16914	14074	34925860
Enuresis	125.13	24.84	46	16951	2307	34937627
Sleep-related eating disorder	120.03	24.84	28	16969	265	34939669
Snoring	116.15	24.84	48	16949	3298	34936636
Acute kidney injury	114.65	24.84	9	16988	304979	34634955
Bipolar disorder	105.33	24.84	46	16951	3623	34936311
Hypertension	103.61	24.84	214	16783	136229	34803705
Initial insomnia	98.99	24.84	42	16955	3082	34936852
Intervertebral disc protrusion	93.45	24.84	59	16938	9897	34930037
Hangover	92.71	24.84	30	16967	1021	34938913
Nephrolithiasis	91.34	24.84	92	16905	30241	34909693
Pyrexia	90.77	24.84	25	16972	332988	34606946
Post-traumatic stress disorder	89.88	24.84	34	16963	1847	34938087
Sleep paralysis	88.29	24.84	20	16977	164	34939770
Condition aggravated	85.27	24.84	245	16752	191951	34747983
Wrong technique in product usage process	83.40	24.84	95	16902	35891	34904043
Disability	82.06	24.84	42	16955	4723	34935211
Feeling drunk	82.02	24.84	32	16965	1891	34938043
Cataplexy	81.79	24.84	21	16976	305	34939629
Restless legs syndrome	74.66	24.84	48	16949	8306	34931628
Poor quality sleep	72.70	24.84	47	16950	8209	34931725
Anaemia	70.45	24.84	14	16983	233321	34706613
Substance use	70.25	24.84	22	16975	672	34939262
Abnormal sleep-related event	68.97	24.84	20	16977	467	34939467
Narcolepsy	67.34	24.84	20	16977	509	34939425
Shoulder operation	67.30	24.84	24	16973	1102	34938832
Drug abuse	66.56	24.84	148	16849	98948	34840986
Alcohol abuse	65.64	24.84	36	16961	4654	34935280
Weight decreased	65.25	24.84	211	16786	176090	34763844
Migraine	61.96	24.84	58	16939	17420	34922514
Abnormal dreams	61.51	24.84	41	16956	7537	34932397
Thrombocytopenia	60.35	24.84	4	16993	156243	34783691
Suicide attempt	58.43	24.84	83	16914	39033	34900901
Pneumonia	55.37	24.84	57	16940	362570	34577364
Parasomnia	54.60	24.84	16	16981	388	34939546
Spinal operation	53.75	24.84	27	16970	2917	34937017
Drug diversion	53.53	24.84	19	16978	860	34939074
Middle insomnia	53.29	24.84	36	16961	6766	34933168
Intentional product use issue	52.73	24.84	100	16897	59716	34880218
Nasopharyngitis	52.11	24.84	109	16888	69859	34870075
Overdose	51.31	24.84	127	16870	90932	34849002
Spinal fusion surgery	50.76	24.84	19	16978	1002	34938932
Death	49.80	24.84	73	16924	397976	34541958
No adverse event	48.87	24.84	58	16939	22869	34917065
Irritability	48.61	24.84	60	16937	24630	34915304
Wrong dose	48.40	24.84	16	16981	583	34939351
Rash	48.35	24.84	24	16973	222728	34717206
Diarrhoea	48.29	24.84	72	16925	389840	34550094
Blood cholesterol increased	47.17	24.84	54	16943	20489	34919445
Intentional product misuse	46.21	24.84	81	16916	45530	34894404
Sepsis	44.34	24.84	13	16984	166548	34773386
Hospitalisation	43.94	24.84	90	16907	56812	34883122
Head injury	43.85	24.84	49	16948	18111	34921823
Road traffic accident	43.71	24.84	48	16949	17402	34922532
Hypotension	43.59	24.84	27	16970	221622	34718312
Back injury	43.13	24.84	26	16971	4015	34935919
Hypnagogic hallucination	42.92	24.84	9	16988	49	34939885
Stress	41.82	24.84	62	16935	30285	34909649
Haemoglobin decreased	41.49	24.84	5	16992	120767	34819167
Knee operation	40.56	24.84	20	16977	2077	34937857
Memory impairment	40.13	24.84	74	16923	43244	34896690
Product use in unapproved indication	40.03	24.84	5	16992	117494	34822440
Food craving	39.71	24.84	13	16984	459	34939475
Attention deficit hyperactivity disorder	36.80	24.84	20	16977	2539	34937395
Tachyphrenia	36.71	24.84	16	16981	1253	34938681
Agitation	36.56	24.84	84	16913	57315	34882619
Feeling jittery	35.76	24.84	23	16974	3980	34935954
Lethargy	35.30	24.84	68	16929	41054	34898880
White blood cell count decreased	35.25	24.84	3	16994	95442	34844492
Concussion	34.94	24.84	19	16978	2414	34937520
Fall	34.77	24.84	192	16805	202693	34737241
Drug tolerance	34.58	24.84	20	16977	2862	34937072
Sleep talking	34.09	24.84	12	16985	530	34939404
Foot operation	34.01	24.84	13	16984	726	34939208
Headache	33.80	24.84	189	16808	200446	34739488
Disease progression	33.59	24.84	6	16991	108071	34831863
Panic attack	32.85	24.84	31	16966	9401	34930533
Lower limb fracture	32.68	24.84	22	16975	4109	34935825
Loss of consciousness	32.36	24.84	101	16896	82566	34857368
Renal failure	31.57	24.84	12	16985	130545	34809389
Prescribed overdose	31.49	24.84	32	16965	10615	34929319
Confusional arousal	31.22	24.84	6	16991	19	34939915
Fibromyalgia	30.67	24.84	19	16978	3081	34936853
Major depression	30.66	24.84	22	16975	4550	34935384
Periodic limb movement disorder	30.38	24.84	8	16989	129	34939805
Product preparation error	30.27	24.84	17	16980	2300	34937634
Nightmare	29.99	24.84	36	16961	14355	34925579
Obesity	29.81	24.84	34	16963	12844	34927090
Gastrointestinal haemorrhage	29.56	24.84	4	16993	88473	34851461
Hyponatraemia	29.46	24.84	3	16994	82688	34857246
Abdominal pain	29.37	24.84	22	16975	163596	34776338
Gastrooesophageal reflux disease	29.28	24.84	60	16937	37864	34902070
Hyperhidrosis	29.18	24.84	92	16905	75600	34864334
Nasal septum deviation	29.03	24.84	13	16984	1086	34938848
Treatment noncompliance	28.57	24.84	50	16947	28050	34911884
Extra dose administered	28.52	24.84	20	16977	3989	34935945
Respiratory failure	27.93	24.84	9	16988	108563	34831371
Craniocerebral injury	27.31	24.84	18	16979	3245	34936689
Incorrect dose administered	26.57	24.84	60	16937	40455	34899479
Moaning	26.34	24.84	11	16986	775	34939159
Psychotic disorder	25.50	24.84	44	16953	24408	34915526
Erythema	25.37	24.84	6	16991	88774	34851160
Tremor	25.34	24.84	93	16904	82494	34857440
Illness	25.22	24.84	32	16965	13497	34926437
Diabetes mellitus	24.92	24.84	64	16933	46809	34893125

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	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
Surgery	289.45	19.59	184	37021	32582	79674601
Initial insomnia	267.19	19.59	106	37099	6832	79700351
Feeling drunk	264.96	19.59	95	37110	4624	79702559
Unevaluable event	259.82	19.59	212	36993	55373	79651810
Insomnia	239.32	19.59	418	36787	244752	79462431
Hangover	238.04	19.59	72	37133	2040	79705143
Acute kidney injury	211.27	19.59	7	37198	519397	79187786
Poor quality sleep	209.16	19.59	131	37074	22591	79684592
Abnormal dreams	204.62	19.59	102	37103	11310	79695873
Snoring	203.78	19.59	82	37123	5484	79701699
Migraine	203.77	19.59	227	36978	87266	79619917
Suicide attempt	194.56	19.59	216	36989	82716	79624467
Sleep paralysis	191.24	19.59	47	37158	591	79706592
Lethargy	186.02	19.59	209	36996	81083	79626100
Therapeutic response unexpected	178.58	19.59	113	37092	19833	79687350
Bipolar disorder	162.60	19.59	77	37128	7630	79699553
Irritability	161.56	19.59	142	37063	41002	79666181
Weight decreased	158.36	19.59	442	36763	354756	79352427
Tremor	152.94	19.59	280	36925	169803	79537380
Condition aggravated	147.95	19.59	541	36664	500583	79206600
Panic attack	147.23	19.59	108	37097	24108	79683075
Cataplexy	141.24	19.59	40	37165	894	79706289
Blood pressure increased	140.85	19.59	307	36898	211053	79496130
Hunger	132.49	19.59	60	37145	5368	79701815
Dizziness	127.47	19.59	534	36671	525907	79181276
Restless legs syndrome	125.30	19.59	91	37114	20001	79687182
Pyrexia	115.40	19.59	89	37116	678620	79028563
Fall	114.38	19.59	490	36715	487139	79220044
Sleep-related eating disorder	109.88	19.59	31	37174	683	79706500
Thrombocytopenia	109.80	19.59	3	37202	265256	79441927
Middle insomnia	107.59	19.59	76	37129	15993	79691190
Abnormal sleep-related event	107.49	19.59	32	37173	857	79706326
Anaemia	107.20	19.59	37	37168	444978	79262205
Narcolepsy	103.88	19.59	34	37171	1252	79705931
General physical health deterioration	101.25	19.59	7	37198	275231	79431952
Wrong technique in product usage process	100.85	19.59	147	37058	73728	79633455
Rash	100.62	19.59	74	37131	578284	79128899
Memory impairment	99.16	19.59	183	37022	111551	79595632
Seizure	98.15	19.59	249	36956	188585	79518598
Road traffic accident	95.98	19.59	110	37095	43554	79663629
Product use issue	93.20	19.59	261	36944	209561	79497622
Agitation	93.15	19.59	167	37038	99548	79607635
Sleep talking	92.68	19.59	30	37175	1066	79706117
Intervertebral disc protrusion	91.66	19.59	81	37124	23540	79683643
Head injury	90.45	19.59	99	37106	37270	79669913
Parasomnia	89.25	19.59	25	37180	536	79706647
Hypnagogic hallucination	88.06	19.59	20	37185	174	79707009
Crying	87.39	19.59	78	37127	22965	79684218
Hysterectomy	86.45	19.59	47	37158	6225	79700958
Drug ineffective	85.55	19.59	242	36963	1080671	78626512
Psychotic disorder	85.48	19.59	101	37104	41301	79665882
Shoulder operation	85.31	19.59	36	37169	2716	79704467
Product use in unapproved indication	84.89	19.59	9	37196	250350	79456833
Stress	84.38	19.59	141	37064	79471	79627712
Back injury	82.83	19.59	55	37150	10468	79696715
Post-traumatic stress disorder	82.72	19.59	42	37163	4839	79702344
Nightmare	81.57	19.59	79	37126	25782	79681401
Haemoglobin decreased	80.66	19.59	6	37199	222113	79485070
Nervousness	76.52	19.59	86	37119	33329	79673854
Extra dose administered	76.12	19.59	48	37157	8367	79698816
Feeling jittery	75.19	19.59	56	37149	12785	79694398
Joint swelling	74.82	19.59	21	37184	288625	79418558
Pneumonia	74.45	19.59	121	37084	660125	79047058
Platelet count decreased	74.43	19.59	4	37201	194660	79512523
Nausea	74.43	19.59	726	36479	956470	78750713
Hallucination	74.26	19.59	139	37066	85606	79621577
Retching	72.00	19.59	62	37143	17405	79689778
Hypotension	71.87	19.59	60	37145	440257	79266926
White blood cell count decreased	71.58	19.59	4	37201	188284	79518899
Alcohol abuse	70.63	19.59	39	37166	5324	79701859
Diarrhoea	69.64	19.59	197	37008	880292	78826891
Hypertension	69.42	19.59	322	36883	330670	79376513
Substance use	68.66	19.59	23	37182	911	79706272
Incorrect dose administered	67.32	19.59	125	37080	76505	79630678
Sudden onset of sleep	64.27	19.59	20	37185	624	79706559
Headache	64.13	19.59	522	36683	653250	79053933
Disease progression	64.12	19.59	6	37199	184356	79522827
Sepsis	60.46	19.59	25	37180	269403	79437780
Hyperhidrosis	60.05	19.59	181	37024	151311	79555872
Concussion	59.15	19.59	43	37162	9460	79697723
Spinal operation	59.00	19.59	40	37165	7877	79699306
Death	58.20	19.59	110	37095	566404	79140779
Pruritus	58.19	19.59	59	37146	394589	79312594
Spinal fusion surgery	57.97	19.59	34	37171	5204	79701979
Alanine aminotransferase increased	57.32	19.59	5	37200	162565	79544618
Tachyphrenia	57.20	19.59	25	37180	2055	79705128
Foot fracture	56.28	19.59	60	37145	21921	79685262
Knee operation	54.42	19.59	34	37171	5832	79701351
Abnormal behaviour	53.39	19.59	75	37130	36346	79670837
Paranoia	53.25	19.59	55	37150	19377	79687806
Loss of consciousness	52.44	19.59	185	37020	167758	79539425
Hallucination, auditory	52.13	19.59	56	37149	20637	79686546
Gastric bypass	50.51	19.59	20	37185	1281	79705902
Respiratory depression	49.88	19.59	63	37142	27567	79679616
Disorientation	49.71	19.59	98	37107	62678	79644505
Overdose	49.24	19.59	193	37012	184013	79523170
Pollakiuria	49.09	19.59	73	37132	37244	79669939
Wrong dose	48.67	19.59	21	37184	1673	79705510
Drug intolerance	48.19	19.59	32	37173	264087	79443096
Erythema	48.06	19.59	22	37183	223268	79483915
Hyponatraemia	47.84	19.59	12	37193	177836	79529347
Vertigo	47.81	19.59	102	37103	68980	79638203
Pleural effusion	47.28	19.59	6	37199	145256	79561927
Ankle fracture	46.44	19.59	48	37157	16921	79690262
Attention deficit hyperactivity disorder	46.17	19.59	25	37180	3284	79703899
Renal failure	44.51	19.59	19	37186	200949	79506234
Aspartate aminotransferase increased	44.46	19.59	6	37199	138635	79568548
Drug diversion	44.32	19.59	18	37187	1232	79705951
Anger	44.21	19.59	47	37158	17115	79690068
Delusion	44.11	19.59	51	37154	20372	79686811
Intentional product misuse	43.79	19.59	120	37085	95045	79612138
Emotional disorder	43.59	19.59	43	37162	14344	79692839
Muscle spasms	43.44	19.59	179	37026	174551	79532632
Confusional state	43.29	19.59	275	36930	317722	79389461
Infection	43.14	19.59	30	37175	241682	79465501
Conduction disorder	42.93	19.59	24	37181	3355	79703828
Victim of sexual abuse	42.71	19.59	14	37191	518	79706665
Leukopenia	42.70	19.59	3	37202	116510	79590673
Abdominal pain	42.32	19.59	73	37132	389496	79317687
Contraindicated product administered	41.66	19.59	11	37194	157527	79549656
Therapeutic product effect incomplete	41.24	19.59	8	37197	141637	79565546
Foot operation	40.44	19.59	28	37177	5705	79701478
Cholecystectomy	39.93	19.59	34	37171	9398	79697785
Major depression	39.31	19.59	33	37172	8947	79698236
Cardiac failure	38.75	19.59	12	37193	154830	79552353
Cardiac arrest	38.54	19.59	16	37189	172080	79535103
Endometriosis	38.48	19.59	23	37182	3645	79703538
Nephrolithiasis	38.40	19.59	80	37125	53211	79653972
Completed suicide	38.22	19.59	35	37170	245732	79461451
Periodic limb movement disorder	37.88	19.59	10	37195	170	79707013
Apnoea	37.37	19.59	36	37169	11668	79695515
Pericarditis	37.30	19.59	3	37202	104233	79602950
Respiratory failure	37.13	19.59	19	37186	180892	79526291
Bruxism	36.50	19.59	23	37182	4003	79703180
Blister	36.40	19.59	6	37199	119470	79587713
Ankle operation	36.26	19.59	15	37190	1076	79706107
Gastrooesophageal reflux disease	36.18	19.59	119	37086	104127	79603056
Lower respiratory tract infection	36.17	19.59	8	37197	129212	79577971
Moaning	35.66	19.59	15	37190	1122	79706061
Product preparation error	35.57	19.59	26	37179	5767	79701416
Mobility decreased	35.36	19.59	7	37198	122168	79585015
Mental disorder	35.25	19.59	57	37148	31245	79675938
Palpitations	34.91	19.59	134	37071	126476	79580707
Muscle tightness	34.39	19.59	36	37169	12878	79694305
No adverse event	34.33	19.59	62	37143	37130	79670053
Hyperkalaemia	34.29	19.59	6	37199	114392	79592791
Victim of spousal abuse	34.14	19.59	6	37199	10	79707173
Coma	34.13	19.59	114	37091	100535	79606648
Product taste abnormal	34.05	19.59	18	37187	2253	79704930
Fibromyalgia	33.53	19.59	85	37120	64255	79642928
Muscle twitching	33.37	19.59	49	37156	24715	79682468
Renal impairment	33.24	19.59	16	37189	157767	79549416
Drug abuse	33.10	19.59	157	37048	162534	79544649
Procedural pain	33.04	19.59	47	37158	23037	79684146
Arthralgia	32.96	19.59	146	37059	571657	79135526
Stomatitis	32.29	19.59	14	37191	146743	79560440
Postural orthostatic tachycardia syndrome	31.50	19.59	13	37192	927	79706256
Incoherent	31.08	19.59	27	37178	7665	79699518
Dry mouth	31.01	19.59	101	37104	87918	79619265
Victim of chemical submission	30.52	19.59	11	37194	543	79706640
Gallbladder operation	30.37	19.59	16	37189	1989	79705194
Thinking abnormal	30.34	19.59	34	37171	13127	79694056
Restlessness	30.28	19.59	67	37138	46425	79660758
Accidental poisoning	30.26	19.59	15	37190	1642	79705541
Rotator cuff syndrome	30.10	19.59	35	37170	14060	79693123
Tooth extraction	29.91	19.59	31	37174	10964	79696219
Perinatal depression	29.76	19.59	10	37195	400	79706783
Glossodynia	29.73	19.59	6	37199	103331	79603852
Intentional product use issue	29.65	19.59	145	37060	151967	79555216
Therapy non-responder	29.58	19.59	4	37201	92301	79614882
Disturbance in attention	29.54	19.59	70	37135	50731	79656452
Blood creatinine increased	29.34	19.59	18	37187	155039	79552144
Choking	29.17	19.59	32	37173	12069	79695114
Euphoric mood	28.98	19.59	26	37179	7700	79699483
Paraesthesia	28.78	19.59	160	37045	176163	79531020
Nerve compression	28.71	19.59	28	37177	9211	79697972
Hypersomnia	28.71	19.59	44	37161	23042	79684141
Rheumatoid arthritis	28.65	19.59	33	37172	208437	79498746
Dyskinesia	28.57	19.59	64	37141	44709	79662474
Intentional dose omission	27.92	19.59	27	37178	8790	79698393
Cardio-respiratory arrest	27.89	19.59	8	37197	108502	79598681
Metabolic acidosis	27.87	19.59	3	37202	82526	79624657
Wheezing	27.51	19.59	10	37195	116654	79590529
Amnesia	27.51	19.59	78	37127	62979	79644204
Wound	27.33	19.59	10	37195	116169	79591014
Food craving	27.33	19.59	14	37191	1643	79705540
Hepatic enzyme increased	27.22	19.59	27	37178	182583	79524600
Medication error	27.16	19.59	82	37123	68560	79638623
Lung disorder	27.02	19.59	3	37202	80554	79626629
Illness	26.95	19.59	64	37141	46447	79660736
Oedema peripheral	26.72	19.59	48	37157	252240	79454943
Urinary tract infection	26.66	19.59	55	37150	274457	79432726
Panic reaction	26.54	19.59	20	37185	4645	79702538
Drug tolerance	26.42	19.59	26	37179	8649	79698534
Obsessive-compulsive disorder	26.40	19.59	22	37183	5905	79701278
Unresponsive to stimuli	26.30	19.59	71	37134	55717	79651466
Drug withdrawal syndrome	26.04	19.59	53	37152	34665	79672518
Essential hypertension	25.99	19.59	22	37183	6031	79701152
Therapeutic product effect decreased	25.86	19.59	23	37182	163840	79543343
Lower limb fracture	25.77	19.59	42	37163	23173	79684010
Inappropriate schedule of product administration	25.76	19.59	127	37078	133501	79573682
Seizure like phenomena	25.75	19.59	14	37191	1853	79705330
Metabolic surgery	25.59	19.59	12	37193	1162	79706021
Essential tremor	25.24	19.59	13	37192	1542	79705641
Rapid eye movements sleep abnormal	25.08	19.59	8	37197	271	79706912
Hormone level abnormal	24.84	19.59	14	37191	1988	79705195
Urticaria	24.71	19.59	30	37175	185171	79522012
Confusional arousal	24.52	19.59	6	37199	74	79707109
Aggression	24.17	19.59	65	37140	50893	79656290
Treatment noncompliance	24.12	19.59	66	37139	52202	79654981
Neuralgia	23.91	19.59	50	37155	33334	79673849
Thirst	23.88	19.59	36	37169	18583	79688600
Sleep attacks	23.86	19.59	7	37198	178	79707005
Musculoskeletal stiffness	23.72	19.59	28	37177	174980	79532203
Dyspnoea	23.66	19.59	271	36934	856754	78850429
Generalised anxiety disorder	23.63	19.59	14	37191	2183	79705000
Haematochezia	23.39	19.59	6	37199	87639	79619544
Nasopharyngitis	23.31	19.59	200	37005	253681	79453502
Disability	23.25	19.59	34	37171	17086	79690097
Dyspnoea exertional	23.17	19.59	6	37199	87067	79620116
Hypokalaemia	22.99	19.59	20	37185	144020	79563163
Sleep terror	22.93	19.59	18	37187	4440	79702743
Gastrectomy	22.90	19.59	9	37196	565	79706618
Investigation	22.75	19.59	14	37191	2337	79704846
Inappropriate affect	22.54	19.59	12	37193	1524	79705659
Intervertebral disc degeneration	22.38	19.59	32	37173	15753	79691430
Hospitalisation	21.43	19.59	94	37111	94142	79613041
Alopecia	21.09	19.59	48	37157	231307	79475876
Asthenia	21.05	19.59	146	37059	511543	79195640
Seborrhoea	20.91	19.59	8	37197	467	79706716
Limb injury	20.88	19.59	44	37161	29484	79677699
Ehlers-Danlos syndrome	20.78	19.59	6	37199	144	79707039
Wisdom teeth removal	20.75	19.59	8	37197	477	79706706
Neck injury	20.60	19.59	14	37191	2767	79704416
Sedation	20.53	19.59	62	37143	51833	79655350
Oxygen saturation decreased	20.50	19.59	18	37187	129029	79578154
Lyme disease	20.49	19.59	15	37190	3335	79703848
International normalised ratio increased	20.42	19.59	7	37198	84714	79622469
Seasonal affective disorder	20.28	19.59	7	37198	304	79706879
Scoliosis	20.22	19.59	21	37184	7443	79699740
Hypopnoea	20.12	19.59	18	37187	5311	79701872
Victim of abuse	20.12	19.59	5	37200	66	79707117
Cheyne-Stokes respiration	20.08	19.59	8	37197	521	79706662
Colonoscopy	19.88	19.59	12	37193	1935	79705248
Blood alkaline phosphatase increased	19.83	19.59	3	37202	63661	79643522
Nocturia	19.79	19.59	28	37177	13653	79693530

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	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.
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	10952986	July 21, 2037	TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11000498	July 21, 2037	TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11400065	July 21, 2037	TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602512	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602513	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	10952986	July 21, 2037	TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11000498	July 21, 2037	TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11400065	July 21, 2037	TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602512	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602513	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	10952986	July 21, 2037	TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11000498	July 21, 2037	TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11400065	July 21, 2037	TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602512	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602513	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	10952986	July 21, 2037	TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11000498	July 21, 2037	TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11400065	July 21, 2037	TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602512	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11602513	July 21, 2037	TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
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
4.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11583510	Feb. 7, 2042	TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11583510	Feb. 7, 2042	TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11583510	Feb. 7, 2042	TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	11583510	Feb. 7, 2042	TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION

Orange Book exclusivity data (new drug applications)

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
0.5GM/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
6GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2026	NEW PRODUCT
7.5GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2026	NEW PRODUCT
9GM/PACKET	LUMRYZ	AVADEL CNS	N214755	May 1, 2023	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	May 1, 2026	NEW PRODUCT
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
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, 2030	TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY
7.5GM/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
9GM/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

Bioactivity Summary:

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

External reference:

ID	Source
D05866	KEGG_DRUG
4021348	VUID
N0000148768	NUI
4021348	VANDF
CHEBI:30830	CHEBI
CHEMBL1200682	ChEMBL_ID
591-81-1	SECONDARY_CAS_RN
DB09072	DRUGBANK_ID
7G33012534	UNII
DB01440	DRUGBANK_ID
1546380	RXNORM
16840	MMSL
326245	MMSL
44375	MMSL
d04806	MMSL
006073	NDDF
006074	NDDF
259470008	SNOMEDCT_US
410917003	SNOMEDCT_US
782570005	SNOMEDCT_US
785621006	SNOMEDCT_US
C0037537	UMLSCUI
D012978	MESH_DESCRIPTOR_UI
CHEMBL1342	ChEMBL_ID
23663870	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
sodium oxybate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-9628	SOLUTION	0.50 g	ORAL	NDA authorized generic	31 sections
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
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
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
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
sodium oxybate	HUMAN PRESCRIPTION DRUG LABEL	1	69238-2391	SOLUTION	0.50 g	ORAL	NDA authorized generic	31 sections