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

Stem definitionDrug idCAS RN
4566 502-85-2

Description:

MoleculeDescription

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:

DoseUnitRoute
7.50 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 17, 2002 FDA JAZZ PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA-B receptor GPCR AGONIST CHEMBL CHEMBL
Gamma-hydroxybutyrate receptor Unclassified IC50 5.18 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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