sodium oxybate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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:

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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
Pre-existing condition improved 1355.62 18.39 406 52861 8763 90566417
Product administration interrupted 1264.24 18.39 414 52853 12078 90563102
Sleep apnoea syndrome 1258.08 18.39 528 52739 31219 90543961
Anxiety 888.34 18.39 998 52269 308774 90266406
Suicidal ideation 867.03 18.39 540 52727 73315 90501865
Somnambulism 801.75 18.39 248 53019 5980 90569200
Somnolence 797.73 18.39 785 52482 208299 90366881
Surgery 690.77 18.39 391 52876 44496 90530684
Feeling abnormal 665.77 18.39 643 52624 166592 90408588
Depression 656.75 18.39 844 52423 299757 90275423
Enuresis 564.83 18.39 165 53102 3249 90571931
Unevaluable event 561.37 18.39 368 52899 54480 90520700
Therapeutic response unexpected 455.30 18.39 233 53034 21647 90553533
Snoring 396.78 18.39 139 53128 4987 90570193
Initial insomnia 296.99 18.39 133 53134 9177 90566003
Weight decreased 290.27 18.39 669 52598 379241 90195939
Panic attack 284.57 18.39 183 53084 26182 90548998
Blood pressure increased 274.62 18.39 448 52819 196769 90378411
Tremor 255.16 18.39 378 52889 152795 90422385
Parasomnia 246.50 18.39 61 53206 615 90574565
Feeling drunk 239.28 18.39 94 53173 4664 90570516
Bipolar disorder 238.54 18.39 113 53154 8872 90566308
Hangover 235.32 18.39 76 53191 2113 90573067
Hunger 232.72 18.39 101 53166 6462 90568718
Migraine 232.53 18.39 408 52859 189984 90385196
Sleep paralysis 229.31 18.39 61 53206 837 90574343
Poor quality sleep 229.17 18.39 156 53111 24537 90550643
Abnormal dreams 225.83 18.39 117 53150 11140 90564040
Restless legs syndrome 223.02 18.39 148 53119 22322 90552858
Insomnia 214.68 18.39 550 52717 332924 90242256
Sleep-related eating disorder 213.32 18.39 59 53208 945 90574235
Post-traumatic stress disorder 197.12 18.39 91 53176 6737 90568443
Intentional dose omission 188.35 18.39 122 53145 17661 90557519
Rash 185.76 18.39 120 53147 795980 89779200
Abnormal sleep-related event 179.61 18.39 50 53217 821 90574359
General physical health deterioration 171.80 18.39 9 53258 355106 90220074
Hysterectomy 170.23 18.39 98 53169 11486 90563694
Pyrexia 166.02 18.39 91 53176 660394 89914786
Wrong technique in product usage process 165.17 18.39 207 53060 71364 90503816
Stress 160.74 18.39 218 53049 81177 90494003
Cataplexy 160.25 18.39 52 53215 1468 90573712
Treatment failure 156.04 18.39 5 53262 303923 90271257
Major depression 155.80 18.39 88 53179 9947 90565233
Glossodynia 153.03 18.39 9 53258 321770 90253410
Fall 150.89 18.39 621 52646 481189 90093991
Joint swelling 150.53 18.39 54 53213 503246 90071934
Acute kidney injury 143.56 18.39 12 53255 320375 90254805
Psychotic disorder 135.19 18.39 126 53141 31104 90544076
Suicide attempt 134.02 18.39 192 53075 75207 90499973
Wound 133.97 18.39 12 53255 302968 90272212
Irritability 133.82 18.39 133 53134 35529 90539651
Nephrolithiasis 131.25 18.39 153 53114 48932 90526248
Crying 125.79 18.39 111 53156 25534 90549646
Seizure 125.34 18.39 277 52990 152352 90422828
Drug ineffective 124.88 18.39 409 52858 1383889 89191291
Diarrhoea 120.75 18.39 231 53036 938959 89636221
Bruxism 119.28 18.39 56 53211 4307 90570873
Product use in unapproved indication 119.17 18.39 26 53241 336210 90238970
Condition aggravated 116.66 18.39 671 52596 594874 89980306
Intervertebral disc protrusion 116.32 18.39 109 53158 27087 90548093
Blister 115.75 18.39 9 53258 254989 90320191
Middle insomnia 114.65 18.39 88 53179 16663 90558517
Neutropenia 114.35 18.39 4 53263 224900 90350280
Perinatal depression 113.87 18.39 35 53232 824 90574356
Mobility decreased 113.39 18.39 9 53258 250725 90324455
Pruritus 112.58 18.39 92 53175 541433 90033747
Stomatitis 111.01 18.39 15 53252 274683 90300497
Nausea 109.83 18.39 1063 52204 1109253 89465927
Narcolepsy 108.88 18.39 39 53228 1493 90573687
Helicobacter infection 108.88 18.39 6 53261 226844 90348336
Retching 108.38 18.39 90 53177 19069 90556111
Feeling jittery 107.95 18.39 82 53185 15289 90559891
Drug intolerance 107.57 18.39 65 53202 447526 90127654
Dizziness 107.05 18.39 651 52616 588633 89986547
Hypertension 106.08 18.39 540 52727 456992 90118188
Illness 105.59 18.39 180 53087 81789 90493391
Maternal exposure during pregnancy 105.27 18.39 40 53227 360023 90215157
Paranoia 104.46 18.39 75 53192 12833 90562347
Sleep talking 104.35 18.39 35 53232 1098 90574082
Lower respiratory tract infection 102.94 18.39 13 53254 250646 90324534
Hospitalisation 101.24 18.39 229 53038 127871 90447309
Hyperhidrosis 100.40 18.39 237 53030 136068 90439112
Thrombocytopenia 98.70 18.39 6 53261 208719 90366461
Substance use 98.51 18.39 34 53233 1165 90574015
Folliculitis 96.25 18.39 6 53261 204347 90370833
Drug diversion 95.07 18.39 32 53235 1015 90574165
Ill-defined disorder 95.01 18.39 3 53264 184888 90390292
Attention deficit hyperactivity disorder 94.14 18.39 47 53220 4137 90571043
Lethargy 93.96 18.39 148 53119 62991 90512189
Nightmare 92.77 18.39 87 53180 21638 90553542
Alopecia 91.13 18.39 94 53173 494977 90080203
Arthropathy 91.07 18.39 51 53216 366191 90208989
Vitamin D deficiency 90.14 18.39 78 53189 17478 90557702
Musculoskeletal stiffness 89.95 18.39 31 53236 296501 90278679
Therapeutic product effect decreased 89.57 18.39 26 53241 277545 90297635
Hallucination 89.15 18.39 148 53119 65811 90509369
Hypnagogic hallucination 88.61 18.39 22 53245 225 90574955
Injection site pain 88.60 18.39 3 53264 173696 90401484
Head injury 88.05 18.39 100 53167 31088 90544092
Infection 87.79 18.39 52 53215 362042 90213138
Arthralgia 87.77 18.39 206 53061 778316 89796864
Rheumatoid factor positive 87.43 18.39 3 53264 171647 90403533
Impaired healing 87.36 18.39 16 53251 234183 90340997
Postural orthostatic tachycardia syndrome 87.25 18.39 37 53230 2235 90572945
Impaired gastric emptying 87.02 18.39 67 53200 12742 90562438
Sudden onset of sleep 86.82 18.39 26 53241 559 90574621
Contraindicated product administered 86.43 18.39 40 53227 320099 90255081
Hepatic enzyme increased 85.78 18.39 53 53214 360683 90214497
Periodic limb movement disorder 85.75 18.39 26 53241 584 90574596
Wheezing 85.16 18.39 18 53249 238062 90337118
Systemic lupus erythematosus 83.55 18.39 55 53212 361841 90213339
Discomfort 82.65 18.39 29 53238 274306 90300874
Victim of sexual abuse 82.40 18.39 26 53241 669 90574511
Nocturia 81.65 18.39 59 53208 10196 90564984
White blood cell count decreased 81.50 18.39 4 53263 167105 90408075
Liver injury 80.35 18.39 5 53262 170562 90404618
Product use issue 80.33 18.39 395 52872 329524 90245656
Apnoea 79.18 18.39 56 53211 9358 90565822
Endometriosis 79.07 18.39 48 53219 6200 90568980
Intentional product use issue 77.75 18.39 292 52975 216600 90358580
Gastric bypass 77.39 18.39 33 53234 2021 90573159
Disease progression 75.58 18.39 4 53263 156611 90418569
Gastrooesophageal reflux disease 75.30 18.39 242 53025 166095 90409085
Ankle fracture 74.63 18.39 75 53192 20295 90554885
Cholecystectomy 74.47 18.39 59 53208 11696 90563484
Alcohol abuse 74.41 18.39 32 53235 2001 90573179
Extra dose administered 73.83 18.39 53 53214 9065 90566115
Haemoglobin decreased 72.68 18.39 6 53261 161950 90413230
Knee operation 72.00 18.39 47 53220 6889 90568291
Death 71.90 18.39 98 53169 456453 90118727
Psoriatic arthropathy 70.75 18.39 23 53244 228312 90346868
Abdominal pain 70.69 18.39 77 53190 395644 90179536
Pneumonia 70.12 18.39 171 53096 637888 89937292
Foot fracture 69.56 18.39 82 53185 26524 90548656
Disability 68.37 18.39 101 53166 40644 90534536
Hypothyroidism 64.92 18.39 114 53153 53013 90522167
Abnormal behaviour 64.63 18.39 73 53194 22555 90552625
Concussion 64.61 18.39 53 53214 11038 90564142
Therapy non-responder 64.40 18.39 4 53263 136700 90438480
Emotional disorder 63.92 18.39 60 53207 14937 90560243
Palpitations 62.85 18.39 200 53067 136528 90438652
Spinal operation 62.09 18.39 50 53217 10146 90565034
Swelling 61.97 18.39 94 53173 418964 90156216
Platelet count decreased 61.66 18.39 5 53262 136964 90438216
Pollakiuria 61.51 18.39 86 53181 32919 90542261
Nervousness 60.89 18.39 87 53180 33969 90541211
Toxicity to various agents 60.85 18.39 48 53219 287798 90287382
Obsessive-compulsive disorder 60.62 18.39 36 53231 4468 90570712
Asthma exercise induced 60.47 18.39 19 53248 482 90574698
Shoulder operation 60.37 18.39 31 53236 2895 90572285
Lyme disease 59.81 18.39 35 53232 4227 90570953
Therapeutic product effect incomplete 59.24 18.39 20 53247 193876 90381304
Acne 58.76 18.39 78 53189 28429 90546751
Nerve compression 58.44 18.39 49 53218 10517 90564663
Erythema 58.29 18.39 31 53236 229215 90345965
Pancytopenia 58.25 18.39 3 53264 120260 90454920
Anaemia 57.28 18.39 74 53193 352728 90222452
Urticaria 56.78 18.39 60 53207 312674 90262506
Lung disorder 56.39 18.39 10 53257 149873 90425307
Generalised anxiety disorder 53.51 18.39 28 53239 2719 90572461
Tachyphrenia 53.22 18.39 24 53243 1682 90573498
Cystitis interstitial 52.98 18.39 24 53243 1700 90573480
Mental disorder 52.63 18.39 79 53188 32239 90542941
Type 2 diabetes mellitus 52.39 18.39 27 53240 203217 90371963
Exposure during pregnancy 52.07 18.39 277 52990 238133 90337047
Vertigo 52.03 18.39 122 53145 69689 90505491
Thirst 50.73 18.39 55 53212 16240 90558940
Pleural effusion 50.66 18.39 4 53263 111987 90463193
Disorientation 50.48 18.39 92 53175 44022 90531158
Liver disorder 50.47 18.39 6 53261 121263 90453917
Memory impairment 49.98 18.39 239 53028 197005 90378175
Asthenia 49.67 18.39 155 53112 533596 90041584
Choking 49.10 18.39 47 53220 11986 90563194
Neuralgia 48.47 18.39 75 53192 31425 90543755
Rheumatoid arthritis 48.33 18.39 87 53180 362527 90212653
Hallucination, auditory 48.14 18.39 53 53214 15922 90559258
Essential tremor 47.68 18.39 21 53246 1391 90573789
Euphoric mood 47.40 18.39 33 53234 5376 90569804
Essential hypertension 47.26 18.39 35 53232 6280 90568900
Delusion 47.14 18.39 49 53218 13791 90561389
Autoimmune thyroiditis 47.13 18.39 34 53233 5859 90569321
Wrong dose 46.75 18.39 23 53244 1961 90573219
Polycystic ovaries 46.09 18.39 33 53234 5621 90569559
Treatment noncompliance 45.98 18.39 97 53170 51630 90523550
Facet joint syndrome 45.98 18.39 3 53264 98386 90476794
Respiratory depression 45.77 18.39 51 53216 15524 90559656
Musculoskeletal pain 45.26 18.39 22 53245 171229 90403951
Neck injury 45.13 18.39 24 53243 2408 90572772
Gait inability 44.92 18.39 15 53252 146441 90428739
Seasonal allergy 44.49 18.39 61 53206 22922 90552258
Incorrect dose administered 44.36 18.39 124 53143 78806 90496374
Inflammation 44.16 18.39 25 53242 178567 90396613
Cardiac failure 44.15 18.39 6 53261 109490 90465690
Disturbance in attention 43.82 18.39 90 53177 47019 90528161
Product preparation error 43.63 18.39 41 53226 10220 90564960
Sepsis 43.28 18.39 26 53241 179788 90395392
Intervertebral disc degeneration 43.11 18.39 52 53215 17222 90557958
Victim of abuse 43.09 18.39 11 53256 127 90575053
Pulmonary fibrosis 43.09 18.39 6 53261 107497 90467683
Mania 42.80 18.39 47 53220 14077 90561103
Agitation 42.32 18.39 110 53157 66988 90508192
Alanine aminotransferase increased 42.18 18.39 9 53258 118329 90456851
Anger 42.17 18.39 46 53221 13674 90561506
Pain 42.10 18.39 379 52888 995962 89579218
Metabolic surgery 41.96 18.39 20 53247 1591 90573589
Leukopenia 41.86 18.39 5 53262 100705 90474475
Grip strength decreased 39.99 18.39 4 53263 92572 90482608
Muscle tightness 39.48 18.39 44 53223 13395 90561785
Loss of consciousness 39.26 18.39 175 53092 140063 90435117
Gastrointestinal haemorrhage 38.73 18.39 4 53263 90244 90484936
Premenstrual dysphoric disorder 37.90 18.39 9 53258 75 90575105
Product dose omission issue 37.79 18.39 297 52970 291390 90283790
Muscle twitching 37.76 18.39 58 53209 24144 90551036
Moaning 36.81 18.39 16 53251 1027 90574153
Hyperpathia 36.76 18.39 7 53260 16 90575164
Product taste abnormal 36.64 18.39 21 53246 2439 90572741
Tooth extraction 36.09 18.39 39 53228 11474 90563706
Incoherent 35.94 18.39 27 53240 4950 90570230
Gastrointestinal disorder 35.62 18.39 60 53207 256627 90318553
Hypersomnia 35.58 18.39 53 53214 21478 90553702
Carpal tunnel syndrome 35.46 18.39 56 53211 23872 90551308
Lip dry 35.33 18.39 8 53259 100947 90474233
Hypercholesterolaemia 35.30 18.39 8 53259 100884 90474296
Headache 35.10 18.39 706 52561 862040 89713140
Victim of chemical submission 35.06 18.39 14 53253 725 90574455
Seborrhoea 34.96 18.39 13 53254 554 90574626
Bursitis 34.65 18.39 17 53250 131637 90443543
Aspartate aminotransferase increased 34.38 18.39 9 53258 102928 90472252
Dyskinesia 34.21 18.39 70 53197 36464 90538716
Urinary incontinence 34.03 18.39 71 53196 37495 90537685
White coat hypertension 33.83 18.39 15 53252 1010 90574170
Joint injury 33.49 18.39 65 53202 32599 90542581
Rotator cuff syndrome 33.49 18.39 44 53223 15875 90559305
Dyspnoea 33.40 18.39 344 52923 880611 89694569
Liver function test increased 33.39 18.39 5 53262 84850 90490330
Respiratory failure 33.18 18.39 14 53253 118404 90456776
Nasal septum deviation 32.78 18.39 18 53249 1925 90573255
Autonomic nervous system imbalance 32.48 18.39 22 53245 3428 90571752
Heart rate increased 32.44 18.39 142 53125 112760 90462420
Mood altered 32.43 18.39 45 53222 17099 90558081
Drug tolerance 32.36 18.39 46 53221 17870 90557310
Gastrectomy 32.36 18.39 14 53253 888 90574292
Muscle spasms 32.36 18.39 256 53011 251627 90323553
Completed suicide 32.16 18.39 23 53244 145035 90430145
Accident 31.92 18.39 29 53238 6925 90568255
Hypopnoea 31.91 18.39 24 53243 4407 90570773
Colonoscopy 31.81 18.39 17 53250 1723 90573457
Temporomandibular joint syndrome 31.72 18.39 23 53244 3994 90571186
Oedema peripheral 31.62 18.39 65 53202 257850 90317330
Wisdom teeth removal 31.50 18.39 13 53254 733 90574447
Meniscus injury 31.41 18.39 31 53236 8206 90566974
Terminal insomnia 31.39 18.39 15 53252 1200 90573980
Scoliosis 31.17 18.39 32 53235 8875 90566305
Foot operation 30.89 18.39 32 53235 8969 90566211
Victim of spousal abuse 30.85 18.39 6 53261 16 90575164
Abdominal discomfort 30.84 18.39 160 53107 477168 90098012
Drug withdrawal syndrome 30.48 18.39 58 53209 28665 90546515
Tonsillectomy 30.36 18.39 14 53253 1033 90574147
Endodontic procedure 29.98 18.39 21 53246 3454 90571726
Hyponatraemia 29.83 18.39 21 53246 133517 90441663
Withdrawal syndrome 29.70 18.39 50 53217 22474 90552706
Upper airway resistance syndrome 29.63 18.39 6 53261 21 90575159
Seizure like phenomena 29.47 18.39 15 53252 1375 90573805
Sleep attacks 29.17 18.39 8 53259 124 90575056
Rapid eye movements sleep abnormal 28.81 18.39 8 53259 130 90575050
Pituitary tumour 28.76 18.39 13 53254 916 90574264
Back disorder 28.75 18.39 53 53214 25578 90549602
Renal failure 28.74 18.39 21 53246 130986 90444194
Hormone level abnormal 28.68 18.39 19 53248 2854 90572326
Hypotension 28.48 18.39 97 53170 325300 90249880
Road traffic accident 28.40 18.39 132 53135 107494 90467686
Ehlers-Danlos syndrome 28.40 18.39 10 53257 364 90574816
Restlessness 28.35 18.39 64 53203 35656 90539524
Psoriasis 28.33 18.39 27 53240 147727 90427453
Rash erythematous 27.64 18.39 3 53264 65101 90510079
Mast cell activation syndrome 27.54 18.39 15 53252 1579 90573601
Oral surgery 27.52 18.39 15 53252 1581 90573599
Hypersensitivity 27.38 18.39 156 53111 454521 90120659
Dental operation 27.17 18.39 15 53252 1621 90573559
Borderline personality disorder 27.17 18.39 13 53254 1043 90574137
Blood potassium decreased 26.83 18.39 75 53192 47652 90527528
Skin exfoliation 26.73 18.39 4 53263 67909 90507271
No adverse event 26.40 18.39 94 53173 67888 90507292
Craniocerebral injury 26.31 18.39 19 53248 3279 90571901
Drug screen positive 26.28 18.39 20 53247 3737 90571443
Post procedural complication 26.08 18.39 43 53224 18999 90556181
Blood creatinine increased 25.33 18.39 14 53253 101372 90473808
Sleep terror 25.31 18.39 21 53246 4443 90570737
Peripheral swelling 25.27 18.39 141 53126 412965 90162215
Hyperkalaemia 25.17 18.39 4 53263 64960 90510220
Panic disorder 24.97 18.39 18 53249 3097 90572083
Multiple organ dysfunction syndrome 24.76 18.39 5 53262 68331 90506849
Blood sodium increased 24.63 18.39 18 53249 3164 90572016
Food craving 24.60 18.39 15 53252 1952 90573228
Limb injury 24.50 18.39 56 53211 31452 90543728
Panic reaction 24.30 18.39 21 53246 4696 90570484
Rash pruritic 24.21 18.39 9 53258 82205 90492975
Neck surgery 24.03 18.39 15 53252 2035 90573145
Thinking abnormal 24.02 18.39 32 53235 11700 90563480
Seasonal affective disorder 23.91 18.39 9 53258 397 90574783
Blood testosterone increased 23.91 18.39 8 53259 249 90574931
Nerve injury 23.83 18.39 31 53236 11075 90564105
Therapeutic product effect prolonged 23.74 18.39 9 53258 405 90574775
Hypertonic bladder 23.71 18.39 20 53247 4328 90570852
Libido increased 23.63 18.39 14 53253 1730 90573450
Unresponsive to stimuli 23.53 18.39 62 53205 38059 90537121
Cartilage injury 23.50 18.39 15 53252 2116 90573064
Pain in extremity 23.30 18.39 162 53105 450367 90124813
Social anxiety disorder 23.29 18.39 10 53257 623 90574557
Frequent bowel movements 23.24 18.39 3 53264 56932 90518248
Mitral valve prolapse 23.16 18.39 16 53251 2575 90572605
Eye contusion 23.02 18.39 16 53251 2600 90572580
Limb operation 23.01 18.39 20 53247 4507 90570673
Tooth disorder 22.80 18.39 54 53213 31036 90544144
Complex regional pain syndrome 22.78 18.39 16 53251 2643 90572537
Sedation 22.61 18.39 71 53196 48100 90527080
Drug abuse 22.47 18.39 102 53165 82245 90492935
Hemiplegic migraine 22.45 18.39 7 53260 173 90575007
Prescribed underdose 22.45 18.39 8 53259 75011 90500169
Circadian rhythm sleep disorder 22.28 18.39 10 53257 693 90574487
Haematochezia 22.20 18.39 7 53260 70906 90504274
Emergency care 22.17 18.39 13 53254 1576 90573604
Migraine with aura 22.14 18.39 17 53250 3219 90571961
Hepatitis 22.12 18.39 7 53260 70732 90504448
Sleep inertia 22.10 18.39 4 53263 6 90575174
Spinal stenosis 22.07 18.39 38 53229 17386 90557794
Affective disorder 22.01 18.39 25 53242 7768 90567412
Blood pressure systolic increased 21.71 18.39 4 53263 58341 90516839
Therapeutic response changed 21.67 18.39 12 53255 1305 90573875
Tinnitus 21.60 18.39 65 53202 43037 90532143
Blood cholesterol abnormal 21.59 18.39 16 53251 2874 90572306
Inappropriate affect 21.56 18.39 11 53256 1014 90574166
Medical procedure 21.33 18.39 9 53258 537 90574643
Agoraphobia 20.98 18.39 9 53258 559 90574621
Expired product administered 20.91 18.39 23 53244 6899 90568281
Rapid eye movement sleep behaviour disorder 20.75 18.39 8 53259 377 90574803
Connective tissue disorder 20.74 18.39 13 53254 1776 90573404
Muscle strain 20.72 18.39 27 53240 9660 90565520
Dysmenorrhoea 20.50 18.39 19 53248 4653 90570527
Diabetes mellitus 20.49 18.39 84 53183 64791 90510389
White blood cell count increased 20.41 18.39 7 53260 67234 90507946
Metabolic acidosis 20.32 18.39 4 53263 55672 90519508
Cardiac arrest 20.32 18.39 19 53248 104916 90470264
Neuropathy peripheral 20.28 18.39 144 53123 136826 90438354
Delayed sleep phase 20.22 18.39 4 53263 12 90575168
Ankle operation 20.20 18.39 12 53255 1490 90573690
Injury 19.99 18.39 55 53212 197294 90377886
Facial bones fracture 19.95 18.39 17 53250 3730 90571450
Gallbladder operation 19.94 18.39 15 53252 2756 90572424
Motion sickness 19.92 18.39 11 53256 1189 90573991
Immunodeficiency common variable 19.75 18.39 8 53259 430 90574750
Progesterone decreased 19.49 18.39 6 53261 142 90575038
Therapeutic procedure 19.45 18.39 10 53257 936 90574244
Face injury 19.34 18.39 17 53250 3888 90571292
Dental care 19.20 18.39 11 53256 1277 90573903
Joint stiffness 19.17 18.39 11 53256 78031 90497149
Peripheral venous disease 19.00 18.39 13 53254 83908 90491272
Thyroidectomy 18.95 18.39 11 53256 1308 90573872
Bipolar I disorder 18.95 18.39 13 53254 2069 90573111
Breast cancer 18.91 18.39 72 53195 53689 90521491
Confusional arousal 18.74 18.39 7 53260 302 90574878
Hypnopompic hallucination 18.70 18.39 5 53262 70 90575110
Adverse event 18.65 18.39 25 53242 117393 90457787
Spinal fusion surgery 18.55 18.39 29 53238 12254 90562926
Abdominal pain upper 18.50 18.39 117 53150 332557 90242623
Appendicectomy 18.50 18.39 16 53251 3580 90571600
Aphonia 18.49 18.39 29 53238 12290 90562890

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 728.39 25.46 296 18788 21312 42580939
Product administration interrupted 548.55 25.46 165 18919 4801 42597450
Pre-existing condition improved 509.42 25.46 139 18945 2824 42599427
Suicidal ideation 397.91 25.46 255 18829 47906 42554345
Depression 343.67 25.46 329 18755 111034 42491217
Somnambulism 278.50 25.46 90 18994 3325 42598926
Product use issue 238.79 25.46 228 18856 76523 42525728
Anxiety 228.42 25.46 273 18811 118287 42483964
Somnolence 222.64 25.46 294 18790 140811 42461440
Feeling abnormal 218.36 25.46 208 18876 69578 42532673
Therapeutic response unexpected 179.48 25.46 92 18992 11289 42590962
Surgery 177.54 25.46 106 18978 17510 42584741
Unevaluable event 167.71 25.46 132 18952 34156 42568095
Enuresis 162.95 25.46 57 19027 2691 42599560
Drug abuse 156.91 25.46 213 18871 104558 42497693
Insomnia 155.71 25.46 226 18858 118027 42484224
Hunger 148.35 25.46 49 19035 1939 42600312
Sleep-related eating disorder 141.73 25.46 33 19051 339 42601912
Snoring 132.15 25.46 54 19030 3919 42598332
Acute kidney injury 124.35 25.46 11 19073 367326 42234925
Blood pressure increased 124.32 25.46 188 18896 101740 42500511
Initial insomnia 114.64 25.46 49 19035 3981 42598270
Hypertension 105.92 25.46 232 18852 166972 42435279
Bipolar disorder 102.77 25.46 45 19039 3877 42598374
Wrong technique in product usage process 100.20 25.46 109 18975 42526 42559725
Sleep paralysis 97.20 25.46 24 19060 322 42601929
Hangover 96.89 25.46 31 19053 1107 42601144
Intervertebral disc protrusion 94.64 25.46 60 19024 11012 42591239
Post-traumatic stress disorder 93.24 25.46 36 19048 2249 42600002
Pyrexia 92.09 25.46 31 19053 394011 42208240
Intentional product use issue 91.09 25.46 135 18949 71698 42530553
Feeling drunk 90.09 25.46 35 19049 2223 42600028
Disability 85.04 25.46 45 19039 5888 42596363
Shoulder operation 81.63 25.46 29 19055 1432 42600819
Parasomnia 80.56 25.46 22 19062 447 42601804
Alcohol abuse 79.47 25.46 38 19046 4011 42598240
Cataplexy 77.88 25.46 21 19063 406 42601845
Nephrolithiasis 75.98 25.46 88 18996 36742 42565509
Restless legs syndrome 74.53 25.46 49 19035 9565 42592686
Narcolepsy 73.03 25.46 22 19062 641 42601610
Substance use 72.92 25.46 28 19056 1723 42600528
Anaemia 70.93 25.46 19 19065 280259 42321992
Poor quality sleep 70.48 25.46 47 19037 9393 42592858
Abnormal sleep-related event 70.48 25.46 20 19064 470 42601781
Abnormal dreams 68.64 25.46 44 19040 8227 42594024
Thrombocytopenia 66.19 25.46 5 19079 190274 42411977
Middle insomnia 65.83 25.46 42 19042 7791 42594460
Condition aggravated 63.85 25.46 258 18826 260496 42341755
Rash 62.53 25.46 23 19061 276931 42325320
Intentional product misuse 61.40 25.46 104 18980 61796 42540455
Pneumonia 59.46 25.46 61 19023 422088 42180163
Weight decreased 59.27 25.46 216 18868 207732 42394519
Migraine 57.99 25.46 64 19020 25350 42576901
Spinal operation 57.64 25.46 31 19053 4189 42598062
Spinal fusion surgery 56.04 25.46 21 19063 1208 42601043
Diarrhoea 55.90 25.46 75 19009 460774 42141477
Suicide attempt 54.64 25.46 84 19000 46016 42556235
Hospitalisation 53.74 25.46 109 18975 74221 42528030
Sepsis 53.33 25.46 12 19072 199322 42402929
Drug diversion 52.91 25.46 19 19065 968 42601283
Nasopharyngitis 52.43 25.46 116 18968 83880 42518371
Product use in unapproved indication 51.62 25.46 10 19074 184446 42417805
Memory impairment 49.29 25.46 84 19000 50138 42552113
Overdose 49.21 25.46 130 18954 105134 42497117
Loss of consciousness 46.19 25.46 117 18967 92237 42510014
Head injury 45.52 25.46 51 19033 20531 42581720
Road traffic accident 45.15 25.46 49 19035 19044 42583207
Feeling jittery 45.12 25.46 27 19057 4471 42597780
Haemoglobin decreased 44.61 25.46 4 19080 132467 42469784
Disease progression 44.18 25.46 6 19078 143650 42458601
Blood cholesterol increased 43.97 25.46 57 19027 26684 42575567
Hypnagogic hallucination 43.82 25.46 9 19075 48 42602203
Back injury 43.35 25.46 26 19058 4322 42597929
Hypotension 41.24 25.46 33 19051 257598 42344653
Wrong dose 40.42 25.46 16 19068 1068 42601183
Prescribed overdose 39.32 25.46 38 19046 12889 42589362
Food craving 39.26 25.46 13 19071 518 42601733
Panic attack 38.46 25.46 35 19049 11010 42591241
Knee operation 37.99 25.46 20 19064 2588 42599663
Nasal septum deviation 37.87 25.46 16 19068 1262 42600989
Attention deficit hyperactivity disorder 37.40 25.46 21 19063 3087 42599164
Gastrooesophageal reflux disease 37.36 25.46 70 19014 44953 42557298
Tachyphrenia 36.05 25.46 16 19068 1423 42600828
Irritability 35.80 25.46 53 19031 28075 42574176
Periodic limb movement disorder 35.39 25.46 9 19075 137 42602114
Agitation 34.80 25.46 84 19000 64230 42538021
Extra dose administered 34.74 25.46 25 19059 5644 42596607
Hyperhidrosis 34.64 25.46 104 18980 90408 42511843
Coma 34.57 25.46 75 19009 53479 42548772
Death 34.43 25.46 103 18981 471082 42131169
Concussion 33.90 25.46 19 19065 2783 42599468
Anger 33.59 25.46 35 19049 12983 42589268
Abdominal pain 33.58 25.46 22 19062 190449 42411802
Fall 33.46 25.46 199 18885 234321 42367930
Sleep talking 33.16 25.46 12 19072 625 42601626
Fibromyalgia 32.92 25.46 21 19063 3892 42598359
No adverse event 32.79 25.46 61 19023 38960 42563291
Erythema 32.38 25.46 5 19079 108788 42493463
Tremor 32.16 25.46 106 18978 96823 42505428
Stress 32.13 25.46 65 19019 44147 42558104
Major depression 31.25 25.46 23 19061 5375 42596876
Drug tolerance 31.07 25.46 19 19065 3271 42598980
Headache 30.92 25.46 198 18886 239171 42363080
Renal failure 30.63 25.46 13 19071 143713 42458538
Treatment noncompliance 30.54 25.46 58 19026 37614 42564637
Gastrointestinal haemorrhage 30.23 25.46 4 19080 97722 42504529
Obesity 30.09 25.46 37 19047 16422 42585829
Respiratory failure 29.96 25.46 10 19074 128122 42474129
Sleep inertia 29.70 25.46 6 19078 29 42602222
Hyponatraemia 29.44 25.46 5 19079 101457 42500794
Confusional arousal 29.21 25.46 6 19078 32 42602219
Pruritus 29.16 25.46 25 19059 188746 42413505
Moaning 28.89 25.46 12 19072 907 42601344
Craniocerebral injury 28.40 25.46 19 19065 3815 42598436
Lower limb fracture 28.38 25.46 21 19063 4946 42597305
Pleural effusion 27.73 25.46 5 19079 97161 42505090
Foot operation 27.49 25.46 11 19073 755 42601496
Asthma exercise induced 26.59 25.46 7 19077 123 42602128
Incorrect dose administered 26.34 25.46 67 19017 52907 42549344
Diabetes mellitus 25.83 25.46 72 19012 60015 42542236

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
Product administration interrupted 942.76 19.62 291 41529 11001 110536478
Sleep apnoea syndrome 873.83 19.62 385 41435 40062 110507417
Somnolence 698.28 19.62 701 41119 296748 110250731
Pre-existing condition improved 642.54 19.62 191 41629 6335 110541144
Feeling abnormal 575.68 19.62 505 41315 180206 110367273
Somnambulism 546.96 19.62 168 41652 6237 110541242
Anxiety 537.15 19.62 656 41164 344422 110203057
Suicidal ideation 522.17 19.62 365 41455 93572 110453907
Depression 493.30 19.62 603 41217 316732 110230747
Surgery 456.86 19.62 249 41571 41034 110506445
Enuresis 421.19 19.62 124 41696 3972 110543507
Unevaluable event 326.29 19.62 229 41591 58998 110488481
Initial insomnia 270.65 19.62 113 41707 10276 110537203
Feeling drunk 255.02 19.62 91 41729 5409 110542070
Snoring 247.18 19.62 94 41726 6690 110540789
Abnormal dreams 244.99 19.62 112 41708 12668 110534811
Hangover 227.98 19.62 69 41751 2433 110545046
Insomnia 223.62 19.62 449 41371 360141 110187338
Sleep paralysis 218.92 19.62 54 41766 864 110546615
Poor quality sleep 214 19.62 133 41687 27944 110519535
Therapeutic response unexpected 204.98 19.62 122 41698 23721 110523758
Panic attack 197.89 19.62 128 41692 28812 110518667
Acute kidney injury 196.00 19.62 11 41809 635419 109912060
Tremor 189.87 19.62 302 41518 201930 110345549
Bipolar disorder 185.53 19.62 83 41737 8924 110538555
Suicide attempt 182.46 19.62 210 41610 103184 110444295
Weight decreased 172.97 19.62 476 41344 467581 110079898
Hunger 172.58 19.62 72 41748 6532 110540947
Blood pressure increased 162.73 19.62 324 41496 258049 110289430
Lethargy 161.65 19.62 188 41632 93388 110454091
Restless legs syndrome 161.23 19.62 106 41714 24520 110522959
Cataplexy 154.30 19.62 43 41777 1126 110546353
Sleep-related eating disorder 149.94 19.62 40 41780 885 110546594
Fall 148.45 19.62 533 41287 602949 109944530
Irritability 140.75 19.62 128 41692 47681 110499798
Migraine 139.11 19.62 240 41580 171412 110376067
Parasomnia 132.88 19.62 35 41785 736 110546743
General physical health deterioration 132.17 19.62 7 41813 425288 110122191
Wrong technique in product usage process 132.03 19.62 164 41656 87184 110460295
Neutropenia 127.33 19.62 3 41817 374617 110172862
Pyrexia 126.94 19.62 93 41727 898172 109649307
Middle insomnia 126.36 19.62 85 41735 20417 110527062
Dizziness 124.63 19.62 558 41262 697635 109849844
Post-traumatic stress disorder 123.89 19.62 57 41763 6539 110540940
Abnormal sleep-related event 122.67 19.62 34 41786 872 110546607
Drug abuse 118.32 19.62 228 41592 177183 110370296
Seizure 117.75 19.62 259 41561 220926 110326553
Rash 115.96 19.62 85 41735 820879 109726600
Thrombocytopenia 114.15 19.62 4 41816 348881 110198598
Narcolepsy 111.98 19.62 36 41784 1552 110545927
Condition aggravated 111.26 19.62 560 41260 734276 109813203
Head injury 107.17 19.62 105 41715 42912 110504567
Febrile neutropenia 105.89 19.62 3 41817 316764 110230715
Crying 105.01 19.62 83 41737 25545 110521934
Product use in unapproved indication 104.63 19.62 21 41799 447356 110100123
Intentional dose omission 104.41 19.62 75 41745 20005 110527474
Sleep talking 102.92 19.62 32 41788 1236 110546243
Psychotic disorder 99.28 19.62 109 41711 50828 110496651
Joint swelling 99.05 19.62 23 41797 442822 110104657
Shoulder operation 98.30 19.62 40 41780 3405 110544074
Hysterectomy 98.26 19.62 52 41768 8062 110539417
Agitation 96.74 19.62 162 41658 112889 110434590
Nervousness 95.65 19.62 92 41728 36759 110510720
Intervertebral disc protrusion 95.22 19.62 81 41739 27617 110519862
Alcohol abuse 93.84 19.62 43 41777 4886 110542593
Hallucination 93.06 19.62 150 41670 101282 110446197
Substance use 92.28 19.62 35 41785 2471 110545008
Nausea 91.25 19.62 786 41034 1234904 109312575
Paranoia 88.54 19.62 71 41749 22303 110525176
Hyperhidrosis 88.21 19.62 209 41611 187089 110360390
Treatment failure 87.90 19.62 4 41816 277230 110270249
Anaemia 84.76 19.62 51 41769 547035 110000444
Hypnagogic hallucination 83.52 19.62 19 41801 210 110547269
Feeling jittery 81.19 19.62 57 41763 14665 110532814
Stress 81.01 19.62 144 41676 105204 110442275
Nightmare 80.70 19.62 86 41734 38777 110508702
Drug ineffective 78.78 19.62 303 41517 1520237 109027242
Diarrhoea 77.27 19.62 201 41619 1139304 109408175
Memory impairment 77.25 19.62 205 41615 196739 110350740
Pneumonia 75.71 19.62 135 41685 876579 109670900
Loss of consciousness 74.64 19.62 202 41618 196104 110351375
Extra dose administered 73.94 19.62 50 41770 12109 110535370
Hypertension 73.72 19.62 384 41436 509700 110037779
Pruritus 72.38 19.62 68 41752 581492 109965987
Haemoglobin decreased 71.64 19.62 6 41814 248721 110298758
Concussion 71.49 19.62 48 41772 11490 110535989
Retching 71.24 19.62 63 41757 22619 110524860
Platelet count decreased 70.90 19.62 4 41816 230439 110317040
Sudden onset of sleep 70.88 19.62 21 41799 687 110546792
White blood cell count decreased 70.52 19.62 4 41816 229386 110318093
Disease progression 69.97 19.62 6 41814 244028 110303451
Product use issue 69.46 19.62 267 41553 311428 110236051
Spinal operation 68.83 19.62 46 41774 10926 110536553
Disorientation 66.85 19.62 106 41714 70565 110476914
Pericarditis 66.81 19.62 4 41816 219110 110328369
Abnormal behaviour 66.65 19.62 78 41742 38961 110508518
Incorrect dose administered 65.17 19.62 130 41690 103511 110443968
Mobility decreased 65.00 19.62 7 41813 237415 110310064
Foot fracture 64.83 19.62 63 41757 25483 110521996
Anger 64.14 19.62 55 41765 18952 110528527
Stomatitis 62.48 19.62 13 41807 270229 110277250
Nephrolithiasis 62.20 19.62 99 41721 66113 110481366
Glossodynia 62.19 19.62 6 41814 221998 110325481
Lower respiratory tract infection 62.10 19.62 9 41811 243097 110304382
Periodic limb movement disorder 61.22 19.62 17 41803 439 110547040
Attention deficit hyperactivity disorder 60.74 19.62 31 41789 4460 110543019
Major depression 60.62 19.62 42 41778 10579 110536900
Headache 60.12 19.62 552 41268 881825 109665654
Cholecystectomy 59.95 19.62 42 41778 10767 110536712
Tachyphrenia 59.26 19.62 25 41795 2331 110545148
Delusion 59.19 19.62 58 41762 23697 110523782
Sepsis 58.91 19.62 25 41795 327321 110220158
Drug intolerance 58.69 19.62 41 41779 406471 110141008
Wheezing 57.54 19.62 13 41807 255217 110292262
Pollakiuria 57.39 19.62 77 41743 44118 110503361
Gastric bypass 55.84 19.62 21 41799 1448 110546031
Hallucination, auditory 55.84 19.62 59 41761 26338 110521141
Knee operation 55.36 19.62 34 41786 6988 110540491
Coma 54.89 19.62 131 41689 117738 110429741
Bruxism 54.86 19.62 30 41790 4964 110542515
Blister 54.54 19.62 10 41810 227366 110320113
Erythema 54.49 19.62 21 41799 291426 110256053
Palpitations 53.80 19.62 157 41663 159055 110388424
Intentional product misuse 53.78 19.62 140 41680 132764 110414715
Hypotension 53.42 19.62 72 41748 523777 110023702
Endometriosis 53.12 19.62 28 41792 4306 110543173
Respiratory depression 53.07 19.62 63 41757 31938 110515541
Emotional disorder 52.98 19.62 46 41774 16114 110531365
Wound 52.73 19.62 12 41808 234425 110313054
Vertigo 52.27 19.62 107 41713 86763 110460716
Spinal fusion surgery 51.77 19.62 36 41784 9120 110538359
Alanine aminotransferase increased 51.39 19.62 5 41815 183768 110363711
Overdose 51.01 19.62 199 41621 233595 110313884
Road traffic accident 50.70 19.62 120 41700 107278 110440201
Gastrointestinal haemorrhage 50.52 19.62 3 41817 165515 110381964
Infection 50.36 19.62 38 41782 362162 110185317
Wrong dose 50.08 19.62 23 41797 2626 110544853
Lung disorder 50.08 19.62 5 41815 180042 110367437
Intentional product use issue 50.08 19.62 206 41614 247700 110299779
Drug diversion 49.83 19.62 19 41801 1361 110546118
Victim of sexual abuse 49.69 19.62 15 41805 524 110546955
Mania 48.53 19.62 49 41771 20747 110526732
Septic shock 47.64 19.62 3 41817 157525 110389954
Therapeutic product effect incomplete 47.34 19.62 13 41807 223792 110323687
Abdominal pain 46.94 19.62 76 41744 512913 110034566
Pleural effusion 46.75 19.62 6 41814 177703 110369776
Mental disorder 46.46 19.62 65 41755 38726 110508753
Illness 45.69 19.62 98 41722 82073 110465406
Hepatic enzyme increased 45.47 19.62 33 41787 320859 110226620
Moaning 45.34 19.62 18 41802 1437 110546042
Liver injury 45.09 19.62 3 41817 150410 110397069
Ankle fracture 44.98 19.62 46 41774 19773 110527706
Product taste abnormal 44.65 19.62 21 41799 2531 110544948
Product dose omission issue 43.51 19.62 238 41582 321544 110225935
Nerve compression 43.34 19.62 35 41785 11102 110536377
Foot operation 41.93 19.62 29 41791 7284 110540195
Leukopenia 41.72 19.62 4 41816 148787 110398692
Aspartate aminotransferase increased 40.65 19.62 6 41814 159930 110387549
Multiple organ dysfunction syndrome 40.20 19.62 5 41815 151705 110395774
Hyponatraemia 40.15 19.62 16 41804 217637 110329842
Urticaria 39.95 19.62 37 41783 318820 110228659
Therapy non-responder 39.76 19.62 6 41814 157301 110390178
Nocturia 39.59 19.62 40 41780 16950 110530529
Restlessness 39.55 19.62 74 41746 56185 110491294
Disturbance in attention 39.24 19.62 78 41742 61917 110485562
Dyskinesia 39.11 19.62 70 41750 51376 110496103
Muscle injury 38.92 19.62 4 41816 140803 110406676
Hospitalisation 38.44 19.62 130 41690 142363 110405116
Rheumatoid factor positive 38.38 19.62 3 41817 131637 110415842
Renal failure 38.12 19.62 19 41801 226555 110320924
Musculoskeletal stiffness 38.07 19.62 30 41790 279792 110267687
Arthralgia 37.87 19.62 159 41661 779473 109768006
Cardiac failure 37.67 19.62 12 41808 187614 110359865
Gastrooesophageal reflux disease 37.47 19.62 151 41669 179825 110367654
Apnoea 37.19 19.62 35 41785 13604 110533875
Muscle twitching 37.11 19.62 51 41769 29884 110517595
Psoriatic arthropathy 37.06 19.62 14 41806 196747 110350732
Muscle tightness 36.69 19.62 36 41784 14726 110532753
Vitamin D deficiency 36.66 19.62 40 41780 18512 110528967
Impaired gastric emptying 36.07 19.62 34 41786 13241 110534238
Impaired healing 35.41 19.62 15 41805 196702 110350777
Alopecia 35.30 19.62 52 41768 364701 110182778
Disability 35.24 19.62 50 41770 30173 110517306
Hypersomnia 35.07 19.62 48 41772 28013 110519466
Euphoric mood 34.90 19.62 28 41792 8799 110538680
Tooth extraction 34.78 19.62 33 41787 12958 110534521
Rotator cuff syndrome 34.57 19.62 37 41783 16757 110530722
Contraindicated product administered 34.56 19.62 26 41794 248241 110299238
Unresponsive to stimuli 34.23 19.62 75 41745 63715 110483764
Thinking abnormal 34.10 19.62 35 41785 15105 110532374
Treatment noncompliance 33.84 19.62 81 41739 72909 110474570
Systemic lupus erythematosus 33.68 19.62 28 41792 254310 110293169
Victim of spousal abuse 33.49 19.62 6 41814 16 110547463
Thirst 33.17 19.62 41 41779 21666 110525813
Neuralgia 33.13 19.62 63 41757 48415 110499064
Death 33.02 19.62 144 41676 698725 109848754
Hyperkalaemia 32.50 19.62 6 41814 135790 110411689
Intervertebral disc degeneration 32.32 19.62 37 41783 18048 110529431
Aggression 32.21 19.62 70 41750 59140 110488339
Neck injury 31.98 19.62 18 41802 3150 110544329
Incoherent 31.96 19.62 26 41794 8332 110539147
Metabolic surgery 31.90 19.62 14 41806 1437 110546042
Drug withdrawal syndrome 31.82 19.62 54 41766 38000 110509479
Rheumatoid arthritis 31.72 19.62 40 41780 299573 110247906
Inflammation 31.32 19.62 17 41803 193221 110354258
Therapeutic product effect decreased 31.01 19.62 28 41792 244288 110303191
Hormone level abnormal 30.95 19.62 16 41804 2364 110545115
Cardiac arrest 30.90 19.62 18 41802 196735 110350744
Obsessive-compulsive disorder 30.84 19.62 24 41796 7217 110540262
Oedema peripheral 30.69 19.62 48 41772 328612 110218867
Respiratory failure 30.68 19.62 22 41798 215310 110332169
Liver disorder 30.57 19.62 8 41812 142235 110405244
Food craving 30.55 19.62 15 41805 1988 110545491
Maternal exposure during pregnancy 30.27 19.62 31 41789 254852 110292627
Victim of abuse 30.09 19.62 7 41813 86 110547393
Perinatal depression 30.07 19.62 10 41810 480 110546999
Blood creatinine increased 29.77 19.62 16 41804 182873 110364606
Ankle operation 29.27 19.62 13 41807 1373 110546106
Back injury 29.24 19.62 59 41761 47340 110500139
Sleep inertia 29.21 19.62 6 41814 39 110547440
Arthropathy 28.79 19.62 40 41780 287482 110259997
Renal impairment 28.53 19.62 18 41802 188427 110359052
Swelling 28.49 19.62 56 41764 350985 110196494
Postural orthostatic tachycardia syndrome 28.42 19.62 14 41806 1868 110545611
Panic reaction 27.94 19.62 20 41800 5302 110542177
Conduction disorder 27.87 19.62 18 41802 4037 110543442
Victim of chemical submission 27.83 19.62 11 41809 868 110546611
Muscle spasms 27.62 19.62 190 41630 277967 110269512
Accidental poisoning 27.48 19.62 15 41805 2472 110545007
Asthenia 27.32 19.62 151 41669 688848 109858631
Metabolic acidosis 27.14 19.62 3 41817 99741 110447738
Essential hypertension 27.07 19.62 23 41797 7824 110539655
Inappropriate affect 26.74 19.62 13 41807 1686 110545793
Rapid eye movements sleep abnormal 26.71 19.62 8 41812 272 110547207
Confusional state 26.34 19.62 282 41538 468398 110079081
Generalised anxiety disorder 25.93 19.62 15 41805 2764 110544715
Circadian rhythm sleep disorder 25.72 19.62 11 41809 1061 110546418
Essential tremor 25.64 19.62 13 41807 1845 110545634
Investigation 25.59 19.62 14 41806 2318 110545161
Limb operation 25.55 19.62 17 41803 4007 110543472
Choking 25.47 19.62 30 41790 15080 110532399
Procedural pain 25.27 19.62 47 41773 35518 110511961
Gallbladder operation 25.25 19.62 14 41806 2379 110545100
Confusional arousal 25.13 19.62 7 41813 183 110547296
Miosis 25.09 19.62 36 41784 21947 110525532
Seizure like phenomena 24.99 19.62 14 41806 2427 110545052
Scoliosis 24.95 19.62 23 41797 8710 110538769
Psoriasis 24.68 19.62 11 41809 139982 110407497
Limb injury 24.60 19.62 48 41772 37588 110509891
Lyme disease 24.47 19.62 17 41803 4299 110543180
Mood altered 24.39 19.62 35 41785 21340 110526139
Endodontic procedure 24.25 19.62 15 41805 3121 110544358
Sleep terror 24.10 19.62 20 41800 6590 110540889
Heart rate increased 24.06 19.62 113 41707 143721 110403758
Haematochezia 23.88 19.62 7 41813 115517 110431962
Sleep attacks 23.77 19.62 7 41813 224 110547255
Asthma exercise induced 23.60 19.62 7 41813 230 110547249
Nasal septum deviation 23.58 19.62 13 41807 2185 110545294
Seasonal allergy 23.54 19.62 33 41787 19689 110527790
Liver function test increased 23.26 19.62 3 41817 88545 110458934
Ligament rupture 23.13 19.62 16 41804 4019 110543460
Spinal stenosis 22.92 19.62 32 41788 19024 110528455
Polycystic ovaries 22.86 19.62 17 41803 4779 110542700
Breast cancer 22.62 19.62 47 41773 38495 110508984
Autoimmune thyroiditis 22.49 19.62 19 41801 6415 110541064
Intervertebral disc operation 22.46 19.62 10 41810 1062 110546417
Product preparation error 22.45 19.62 24 41796 10855 110536624
Terminal insomnia 22.28 19.62 12 41808 1926 110545553
Delayed sleep phase 21.68 19.62 5 41815 59 110547420
Drug dependence 21.58 19.62 54 41766 49966 110497513
Tonsillectomy 21.49 19.62 9 41811 824 110546655
Cheyne-Stokes respiration 21.46 19.62 8 41812 538 110546941
Substance abuse 21.43 19.62 25 41795 12438 110535041
Joint injury 21.43 19.62 47 41773 39947 110507532
Seborrhoea 21.38 19.62 8 41812 544 110546935
Lip dry 20.81 19.62 6 41814 100077 110447402
Drug screen positive 20.52 19.62 18 41802 6392 110541087
Bipolar I disorder 20.45 19.62 12 41808 2271 110545208
Substance use disorder 20.44 19.62 19 41801 7271 110540208
Sedation 20.06 19.62 65 41755 69618 110477861
Post procedural complication 19.91 19.62 36 41784 26622 110520857
Dyspnoea 19.84 19.62 297 41523 1106575 109440904
Hypokalaemia 19.68 19.62 24 41796 182424 110365055
Pulmonary fibrosis 19.65 19.62 7 41813 102035 110445444

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 D002492 Central Nervous System Depressants
MeSH PA D018686 Anesthetics, Intravenous
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:48407 antiparkinson drug

Related Drugs by ATC class:

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N07XX Other nervous system drugs 23 drugs
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Drug Use | Suggest Off label Use Form| |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
0.234GM/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 11986446 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 11986446 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 11986446 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
4.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11986451 July 21, 2037 TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
4.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12097176 July 21, 2037 TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION
4.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12128021 July 21, 2037 TREATMENT OF A DISORDER IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
4.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12303478 July 21, 2037 METHOD OF DECREASING EXCESSIVE DAYTIME SLEEPINESS BY ORALLY ADMINISTERING A DOSE PROPORTIONAL, PHARMACEUTICAL COMPOSITION COMPRISING IMMEDIATE RELEASE AND MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE PORTIONS ONCE DAILY AT BEDTIME
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
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11826335 July 21, 2037 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WITH A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11986451 July 21, 2037 TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12097176 July 21, 2037 TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12128021 July 21, 2037 TREATMENT OF A DISORDER IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12303478 July 21, 2037 METHOD OF DECREASING EXCESSIVE DAYTIME SLEEPINESS BY ORALLY ADMINISTERING A DOSE PROPORTIONAL, PHARMACEUTICAL COMPOSITION COMPRISING IMMEDIATE RELEASE AND MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE PORTIONS ONCE DAILY AT BEDTIME
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
7.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11986451 July 21, 2037 TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
7.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12097176 July 21, 2037 TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION
7.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12128021 July 21, 2037 TREATMENT OF A DISORDER IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
7.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12303478 July 21, 2037 METHOD OF DECREASING EXCESSIVE DAYTIME SLEEPINESS BY ORALLY ADMINISTERING A DOSE PROPORTIONAL, PHARMACEUTICAL COMPOSITION COMPRISING IMMEDIATE RELEASE AND MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE PORTIONS ONCE DAILY AT BEDTIME
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
9GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11986451 July 21, 2037 TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
9GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12097176 July 21, 2037 TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION
9GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12128021 July 21, 2037 TREATMENT OF A DISORDER IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
9GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 12303478 July 21, 2037 METHOD OF DECREASING EXCESSIVE DAYTIME SLEEPINESS BY ORALLY ADMINISTERING A DOSE PROPORTIONAL, PHARMACEUTICAL COMPOSITION COMPRISING IMMEDIATE RELEASE AND MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE PORTIONS ONCE DAILY AT BEDTIME
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
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML XYWAV JAZZ N212690 July 21, 2020 RX SOLUTION ORAL 12138233 Feb. 22, 2041 TREATMENT OF IDIOPATHIC HYPERSOMNIA WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML XYWAV JAZZ N212690 July 21, 2020 RX SOLUTION ORAL 12582622 Feb. 22, 2041 TREATMENT OF IDIOPATHIC HYPERSOMNIA WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB
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
4.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11779557 March 16, 2042 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WHO HAVE AN APNEA/HYPOPNEA INDEX ≤15 WITH A ONCE-NIGHTLY FORMULATION OF GAMMA-HYDROXYBUTYRATE
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11779557 March 16, 2042 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WHO HAVE AN APNEA/HYPOPNEA INDEX ≤15 WITH A ONCE-NIGHTLY FORMULATION OF GAMMA-HYDROXYBUTYRATE
7.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11779557 March 16, 2042 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WHO HAVE AN APNEA/HYPOPNEA INDEX ≤15 WITH A ONCE-NIGHTLY FORMULATION OF GAMMA-HYDROXYBUTYRATE
9GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 11779557 March 16, 2042 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WHO HAVE AN APNEA/HYPOPNEA INDEX ≤15 WITH A ONCE-NIGHTLY FORMULATION OF GAMMA-HYDROXYBUTYRATE

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 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 Jan. 21, 2028 PEDIATRIC EXCLUSIVITY
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
4.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL Oct. 16, 2031 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
6GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL Oct. 16, 2031 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
7.5GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL Oct. 16, 2031 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
9GM/PACKET LUMRYZ AVADEL CNS N214755 May 1, 2023 RX FOR SUSPENSION, EXTENDED RELEASE ORAL Oct. 16, 2031 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
GABA-B receptor GPCR AGONIST CHEMBL CHEMBL
Calcium/calmodulin-dependent protein kinase type II subunit alpha Kinase Ki 5.37 CHEMBL
Gamma-hydroxybutyrate receptor Unclassified IC50 5.18 CHEMBL

External reference:

IDSource
D05866 KEGG_DRUG
4021348 VUID
N0000148768 NUI
4021348 VANDF
CHEMBL1200682 ChEMBL_ID
CHEMBL1342 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
CHEBI:30830 CHEBI
23663870 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-001 FOR SUSPENSION, EXTENDED RELEASE 4.50 g ORAL NDA 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-002 FOR SUSPENSION, EXTENDED RELEASE 6 g ORAL NDA 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-002 FOR SUSPENSION, EXTENDED RELEASE 6 g ORAL NDA 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-003 FOR SUSPENSION, EXTENDED RELEASE 7.50 g ORAL NDA 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-003 FOR SUSPENSION, EXTENDED RELEASE 7.50 g ORAL NDA 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-004 FOR SUSPENSION, EXTENDED RELEASE 9 g ORAL NDA 22 sections
Lumryz HUMAN PRESCRIPTION DRUG LABEL 1 13551-004 FOR SUSPENSION, EXTENDED RELEASE 9 g ORAL NDA 22 sections
sodium oxybate HUMAN PRESCRIPTION DRUG LABEL 1 31722-891 SOLUTION 0.50 g ORAL ANDA 30 sections
Sodium Oxybate HUMAN PRESCRIPTION DRUG LABEL 1 65162-065 SOLUTION 500 mg ORAL ANDA 28 sections
Xyrem HUMAN PRESCRIPTION DRUG LABEL 1 68727-100 SOLUTION 0.50 g ORAL NDA 30 sections
XYWAV HUMAN PRESCRIPTION DRUG LABEL 4 68727-150 SOLUTION 0.50 g ORAL NDA 30 sections
sodium oxybate HUMAN PRESCRIPTION DRUG LABEL 1 72865-349 SOLUTION 0.50 g ORAL ANDA 30 sections