zolpidem Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
hypnotics/sedatives, zolpidem derivatives 2870 82626-48-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ambien
  • zolpidem
  • zolpidem tartrate
An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.
  • Molecular weight: 307.40
  • Formula: C19H21N3O
  • CLOGP: 3.03
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 37.61
  • ALOGS: -3.99
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 23 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.47 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.54 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.08 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 16, 1992 FDA SANOFI AVENTIS US

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
Completed suicide 1695.82 9.42 2073 157094 136128 53053771
Drug abuse 914.54 9.42 1051 158116 64475 53125424
Intentional overdose 683.78 9.42 920 158247 66285 53123614
Toxicity to various agents 626.31 9.42 1748 157419 217850 52972049
Somnambulism 535.71 9.42 280 158887 5122 53184777
Drug dependence 531.24 9.42 470 158697 21002 53168897
Suicide attempt 516.46 9.42 746 158421 57422 53132477
Rheumatoid arthritis 476.43 9.42 172 158995 314359 52875540
Amnesia 400.74 9.42 580 158587 44708 53145191
Sopor 332.95 9.42 361 158806 20723 53169176
Overdose 308.71 9.42 860 158307 106876 53083023
Contraindicated product administered 307.73 9.42 26 159141 135603 53054296
Intentional self-injury 305.31 9.42 377 158790 24907 53164992
Drug intolerance 299.77 9.42 119 159048 205374 52984525
Synovitis 264.31 9.42 14 159153 107879 53082020
Joint swelling 257.89 9.42 194 158973 234444 52955455
Coma 253.77 9.42 566 158601 61217 53128682
Treatment failure 244.23 9.42 44 159123 128359 53061540
Infusion related reaction 231.20 9.42 88 159079 155869 53034030
Drug ineffective 228.93 9.42 1467 157700 815778 52374121
Hand deformity 228.72 9.42 5 159162 84844 53105055
Insomnia 224.83 9.42 1128 158039 185944 53003955
Abnormal sleep-related event 224.35 9.42 85 159082 684 53189215
Anxiety 217.62 9.42 1159 158008 195545 52994354
Systemic lupus erythematosus 215.97 9.42 54 159113 125360 53064539
Intentional product misuse 204.50 9.42 454 158713 48938 53140961
Cardio-respiratory arrest 188.25 9.42 489 158678 58269 53131630
Poisoning deliberate 186.68 9.42 176 158991 8537 53181362
Somnolence 186.60 9.42 990 158177 166744 53023155
Arthropathy 182.73 9.42 97 159070 141356 53048543
Drug withdrawal syndrome 180.02 9.42 310 158857 27712 53162187
Off label use 176.78 9.42 767 158400 471445 52718454
Glossodynia 173.01 9.42 43 159124 100248 53089651
Respiratory arrest 160.44 9.42 327 158840 33213 53156686
Sleep-related eating disorder 159.80 9.42 67 159100 721 53189178
Maternal exposure during pregnancy 159.24 9.42 138 159029 155501 53034398
Depression 157.80 9.42 1010 158157 182042 53007857
Poisoning 152.08 9.42 197 158970 13653 53176246
Peripheral swelling 149.56 9.42 240 158927 205868 52984031
Lower respiratory tract infection 143.95 9.42 46 159121 90935 53098964
Hypersensitivity 140.34 9.42 259 158908 210406 52979493
Suicidal ideation 130.05 9.42 437 158730 60074 53129825
Pericarditis 127.00 9.42 20 159147 64386 53125513
Alopecia 126.02 9.42 325 158842 234258 52955641
Swelling 121.11 9.42 242 158925 190863 52999036
Mydriasis 121.09 9.42 159 159008 11167 53178732
Wound 120.85 9.42 61 159106 91496 53098403
Fall 119.86 9.42 1612 157555 356828 52833071
Abdominal discomfort 110.66 9.42 317 158850 220745 52969154
Abnormal behaviour 109.12 9.42 217 158950 21649 53168250
Loss of consciousness 108.90 9.42 647 158520 113565 53076334
Arthralgia 105.98 9.42 823 158344 438960 52750939
Withdrawal syndrome 102.95 9.42 197 158970 19104 53170795
Road traffic accident 102.03 9.42 232 158935 25399 53164500
Impaired driving ability 101.97 9.42 92 159075 4215 53185684
Infection 99.18 9.42 230 158937 171975 53017924
Rash 97.49 9.42 857 158310 445334 52744565
Therapeutic product effect decreased 93.28 9.42 144 159023 125511 53064388
Restlessness 91.20 9.42 235 158932 27852 53162047
Drug hypersensitivity 89.41 9.42 447 158720 264795 52925104
Nasopharyngitis 88.18 9.42 287 158880 192008 52997891
Miosis 85.45 9.42 105 159062 6897 53183002
Confusional state 84.20 9.42 918 158249 193303 52996596
Drug use disorder 82.66 9.42 72 159095 3147 53186752
Duodenal ulcer perforation 81.83 9.42 6 159161 35177 53154722
Agitation 81.50 9.42 369 158798 58257 53131642
Exposure via ingestion 79.97 9.42 71 159096 3184 53186715
Disorientation 79.95 9.42 279 158888 39080 53150819
Product use issue 77.51 9.42 190 158977 139394 53050505
Homicide 75.46 9.42 32 159135 355 53189544
Helicobacter infection 75.08 9.42 13 159154 39056 53150843
Musculoskeletal stiffness 72.43 9.42 163 159004 123205 53066694
Cardiac arrest 71.66 9.42 502 158665 93165 53096734
Hepatic enzyme increased 68.33 9.42 174 158993 126021 53063878
Therapeutic product effect incomplete 68.28 9.42 105 159062 91679 53098220
Delirium 66.21 9.42 272 158895 41157 53148742
Product substitution issue 64.69 9.42 145 159022 15721 53174178
Mental status changes 62.60 9.42 259 158908 39312 53150587
Drug abuser 62.45 9.42 61 159106 3092 53186807
Discomfort 59.48 9.42 122 159045 95350 53094549
Folliculitis 57.85 9.42 12 159155 31697 53158202
Bradypnoea 56.54 9.42 59 159108 3238 53186661
Bradyphrenia 56.12 9.42 84 159083 6666 53183233
Disturbance in attention 55.14 9.42 226 158941 34157 53155742
Sleep disorder due to general medical condition, insomnia type 54.28 9.42 5 159162 24344 53165555
Blister 54.00 9.42 95 159072 78658 53111241
Sleep talking 53.04 9.42 35 159132 1001 53188898
Affect lability 52.86 9.42 98 159069 9277 53180622
Muscle injury 52.81 9.42 12 159155 29754 53160145
Product use in unapproved indication 51.84 9.42 167 159000 112122 53077777
Exposure during pregnancy 50.75 9.42 196 158971 124664 53065235
Hallucination 50.63 9.42 304 158863 53534 53136365
Prescription form tampering 50.13 9.42 29 159138 652 53189247
Akathisia 50.10 9.42 91 159076 8480 53181419
Substance abuse 49.45 9.42 64 159103 4430 53185469
Pain 48.06 9.42 1363 157804 587035 52602864
Myocardial depression 47.88 9.42 25 159142 456 53189443
Dependence 47.30 9.42 44 159123 2097 53187802
Tremor 47.13 9.42 578 158589 125158 53064741
Mental disorder 47.10 9.42 170 158997 24206 53165693
Hallucination, visual 45.87 9.42 142 159025 18690 53171209
Tachycardia 45.69 9.42 509 158658 107703 53082196
Immobilisation prolonged 45.45 9.42 15 159152 76 53189823
Altered state of consciousness 45.30 9.42 170 158997 24666 53165233
Alcohol abuse 42.89 9.42 41 159126 2023 53187876
Psychomotor skills impaired 42.80 9.42 43 159124 2256 53187643
Decorticate posture 42.51 9.42 21 159146 339 53189560
Ill-defined disorder 42.38 9.42 51 159116 49393 53140506
Cough 41.11 9.42 530 158637 256363 52933536
Condition aggravated 39.83 9.42 635 158532 296499 52893400
Premature delivery 38.19 9.42 15 159152 26089 53163810
Victim of sexual abuse 37.09 9.42 22 159145 519 53189380
Listless 37.02 9.42 42 159125 2534 53187365
Depressed level of consciousness 36.63 9.42 283 158884 54145 53135754
Logorrhoea 36.52 9.42 41 159126 2445 53187454
Drug detoxification 36.40 9.42 16 159151 195 53189704
Anaphylactic reaction 35.92 9.42 75 159092 58251 53131648
Persistent genital arousal disorder 35.87 9.42 18 159149 301 53189598
Drug withdrawal convulsions 35.86 9.42 31 159136 1341 53188558
Drug tolerance 35.85 9.42 54 159113 4309 53185590
Dissociative disorder 35.55 9.42 16 159151 207 53189692
Illusion 34.95 9.42 28 159139 1088 53188811
Device expulsion 34.85 9.42 23 159144 29790 53160109
Memory impairment 34.11 9.42 395 158772 84362 53105537
Aggression 33.78 9.42 149 159018 23254 53166645
High risk sexual behaviour 33.72 9.42 7 159160 0 53189899
Red blood cell sedimentation rate increased 33.68 9.42 21 159146 28036 53161863
Accidental overdose 33.51 9.42 140 159027 21339 53168560
Victim of chemical submission 32.68 9.42 16 159151 253 53189646
Irritability 32.50 9.42 180 158987 30773 53159126
Anterograde amnesia 31.81 9.42 19 159148 454 53189445
Pruritus 31.78 9.42 652 158515 293180 52896719
Dysarthria 31.34 9.42 218 158949 40350 53149549
Chemical submission 30.31 9.42 14 159153 193 53189706
Parasomnia 30.18 9.42 18 159149 429 53189470
Gastrointestinal disorder 30.07 9.42 152 159015 89852 53100047
Hypokalaemia 30.04 9.42 429 158738 96088 53093811
Intentional product use issue 29.96 9.42 113 159054 72381 53117518
Tardive dyskinesia 29.87 9.42 71 159096 7999 53181900
Respiratory depression 29.75 9.42 95 159072 12711 53177188
Hip arthroplasty 29.32 9.42 24 159143 27838 53162061
Mania 28.63 9.42 89 159078 11740 53178159
Impaired healing 28.58 9.42 97 159070 64108 53125791
Panic attack 28.41 9.42 133 159034 21285 53168614
Dyspnoea 28.40 9.42 1445 157722 584787 52605112
Nightmare 27.92 9.42 116 159051 17635 53172264
Blood pressure fluctuation 27.91 9.42 39 159128 35431 53154468
Wheezing 27.46 9.42 101 159066 65174 53124725
Neutropenia 27.10 9.42 324 158843 158861 53031038
Vertigo 27.03 9.42 271 158896 55810 53134089
Urinary retention 26.92 9.42 161 159006 28305 53161594
Injury 26.88 9.42 251 158916 50720 53139179
Drug resistance 26.78 9.42 13 159154 19949 53169950
Initial insomnia 26.73 9.42 52 159115 5103 53184796
Unresponsive to stimuli 26.64 9.42 181 158986 33245 53156654
Arthritis 26.63 9.42 152 159015 87146 53102753
Coma scale abnormal 26.57 9.42 52 159115 5126 53184773
Urticaria 26.54 9.42 268 158899 135617 53054282
Blood pressure systolic increased 26.38 9.42 40 159127 35137 53154762
Head injury 26.31 9.42 149 159018 25684 53164215
Parkinsonism hyperpyrexia syndrome 26.03 9.42 13 159154 215 53189684
Drop attacks 26.02 9.42 20 159147 731 53189168
Hyponatraemia 25.98 9.42 462 158705 108145 53081754
Obstructive airways disorder 25.52 9.42 10 159157 17419 53172480
Prescription drug used without a prescription 25.36 9.42 29 159138 1765 53188134
Hallucination, auditory 25.25 9.42 85 159082 11688 53178211
Multiple sclerosis relapse 25.24 9.42 224 158943 44629 53145270
Drug screen positive 25.07 9.42 43 159124 3829 53186070
Behaviour disorder 25.04 9.42 34 159133 2466 53187433
COVID-19 23.94 9.42 46 159121 36842 53153057
Asthma 23.81 9.42 209 158958 108763 53081136
Mobility decreased 23.70 9.42 132 159035 76139 53113760
Erythema 23.21 9.42 329 158838 156640 53033259
Electrocardiogram QT prolonged 23.19 9.42 264 158903 56139 53133760
Rhabdomyolysis 23.01 9.42 216 158951 43707 53146192
Hangover 22.93 9.42 25 159142 1443 53188456
Incoherent 22.86 9.42 46 159121 4626 53185273
Euphoric mood 22.65 9.42 45 159122 4484 53185415
Pyrexia 22.64 9.42 978 158189 402215 52787684
Bulimia nervosa 22.16 9.42 16 159151 531 53189368
Renal impairment 21.84 9.42 152 159015 83166 53106733
Psychomotor retardation 21.74 9.42 39 159128 3599 53186300
Dehydration 21.72 9.42 657 158510 167753 53022146
C-reactive protein increased 21.36 9.42 117 159050 67769 53122130
Sinusitis 21.31 9.42 364 158803 168200 53021699
Psychotic disorder 21.22 9.42 135 159032 24250 53165649
Emotional distress 21.17 9.42 167 159000 32150 53157749
Psychomotor hyperactivity 20.87 9.42 72 159095 10024 53179875
Administration site discomfort 20.75 9.42 9 159158 106 53189793
Rheumatoid nodule 20.61 9.42 5 159162 11859 53178040
Apathy 20.54 9.42 63 159104 8249 53181650
Crying 20.47 9.42 125 159042 22137 53167762
Drug interaction 20.39 9.42 824 158343 218505 52971394
Imprisonment 20.07 9.42 11 159156 222 53189677
Live birth 19.91 9.42 10 159157 15049 53174850
Generalised tonic-clonic seizure 19.61 9.42 150 159017 28608 53161291
Hypotension 19.52 9.42 936 158231 253140 52936759
Parkinsonism 19.27 9.42 65 159102 8948 53180951
Major depression 19.24 9.42 58 159109 7524 53182375
Fatigue 18.85 9.42 1901 157266 728605 52461294
Tracheal atresia 18.76 9.42 6 159161 27 53189872
Ventricular hypokinesia 18.75 9.42 41 159126 4371 53185528
Amnestic disorder 18.70 9.42 12 159155 327 53189572
Coagulation factor V level decreased 18.41 9.42 12 159155 336 53189563
Foreign body 18.41 9.42 27 159140 2104 53187795
Femoral neck fracture 18.40 9.42 61 159106 8322 53181577
Sinus tachycardia 18.40 9.42 127 159040 23445 53166454
Stomatitis 17.78 9.42 197 158970 97961 53091938
Derailment 17.70 9.42 7 159160 64 53189835
Feeling drunk 17.63 9.42 38 159129 4011 53185888
Knee arthroplasty 17.60 9.42 47 159120 33522 53156377
Inappropriate schedule of product administration 17.08 9.42 142 159025 74736 53115163
Herpes zoster 17.05 9.42 140 159027 73879 53116020
Psoriatic arthropathy 16.89 9.42 80 159087 48110 53141789
Diplopia 16.88 9.42 113 159054 20652 53169247
Syncope 16.68 9.42 445 158722 111548 53078351
Anger 16.48 9.42 77 159090 12313 53177586
Abnormal dreams 16.46 9.42 69 159098 10532 53179367
Panic disorder 16.30 9.42 29 159138 2659 53187240
Reduced facial expression 16.29 9.42 23 159144 1731 53188168
Alcohol use 16.24 9.42 25 159142 2033 53187866
Protrusion tongue 16.18 9.42 11 159156 331 53189568
Pneumonia aspiration 16.17 9.42 165 159002 34136 53155763
Carotid artery thrombosis 15.89 9.42 19 159148 1213 53188686
Cytomegalovirus infection 15.86 9.42 21 159146 19518 53170381
Inappropriate antidiuretic hormone secretion 15.73 9.42 87 159080 14864 53175035
Prothrombin time shortened 15.59 9.42 23 159144 1801 53188098
Legal problem 15.54 9.42 5 159162 23 53189876
Product complaint 15.45 9.42 75 159092 12182 53177717
Autonomic nervous system imbalance 15.44 9.42 28 159139 2606 53187293
Vision blurred 15.40 9.42 349 158818 85255 53104644
Laryngeal pain 15.37 9.42 39 159128 4577 53185322
Bone erosion 15.36 9.42 7 159160 11145 53178754
Loss of proprioception 15.29 9.42 11 159156 363 53189536
Cholecystitis chronic 15.20 9.42 67 159100 10451 53179448
Productive cough 15.11 9.42 103 159064 56626 53133273
Pneumonia 15.10 9.42 1029 158138 406140 52783759
Inflammation 15.09 9.42 104 159063 57032 53132867
Pulmonary vasculitis 15.06 9.42 6 159161 56 53189843
Mucosal inflammation 15.01 9.42 71 159096 42713 53147186
Blood pressure diastolic decreased 14.75 9.42 17 159150 16786 53173113
Adjustment disorder 14.67 9.42 23 159144 1900 53187999
Aortic valve calcification 14.46 9.42 11 159156 396 53189503
Incomplete spinal fusion 14.45 9.42 3 159164 0 53189899
Serotonin syndrome 14.41 9.42 131 159036 26275 53163624
Facial nerve disorder 14.33 9.42 13 159154 600 53189299
Cognitive disorder 14.31 9.42 200 158967 44578 53145321
Extrapyramidal disorder 14.30 9.42 74 159093 12328 53177571
Bladder sphincter atony 14.19 9.42 8 159159 171 53189728
Analgesic drug level above therapeutic 13.94 9.42 8 159159 177 53189722
Joint range of motion decreased 13.87 9.42 20 159147 17936 53171963
General physical health deterioration 13.86 9.42 333 158834 146609 53043290
Personality disorder 13.86 9.42 35 159132 4096 53185803
Grip strength decreased 13.82 9.42 9 159158 11740 53178159
Poor sucking reflex 13.78 9.42 8 159159 181 53189718
Persecutory delusion 13.77 9.42 27 159140 2665 53187234
Frostbite 13.76 9.42 4 159163 12 53189887
Hypothermia 13.75 9.42 76 159091 12980 53176919
Terminal insomnia 13.64 9.42 13 159154 639 53189260
Inadequate analgesia 13.57 9.42 28 159139 2867 53187032
Mood swings 13.52 9.42 94 159073 17392 53172507
Disinhibition 13.48 9.42 15 159152 886 53189013
Self-injurious ideation 13.45 9.42 25 159142 2371 53187528
Decreased interest 13.44 9.42 30 159137 3243 53186656
Spinal rod insertion 13.30 9.42 4 159163 14 53189885
Genitourinary symptom 13.24 9.42 6 159161 79 53189820
Accidental poisoning 13.23 9.42 13 159154 664 53189235
Hepatotoxicity 13.18 9.42 41 159126 27839 53162060
Hypokinesia 13.17 9.42 75 159092 12952 53176947
Therapy non-responder 13.17 9.42 89 159078 49031 53140868
Neonatal behavioural syndrome 13.12 9.42 5 159162 41 53189858
Injection site reaction 13.09 9.42 94 159073 51072 53138827
Multiple injuries 13.06 9.42 22 159145 1931 53187968
Occupational dermatitis 13.01 9.42 5 159162 42 53189857
Peripheral paralysis 12.97 9.42 6 159161 83 53189816
Neurotoxicity 12.97 9.42 16 159151 15333 53174566
Angioedema 12.97 9.42 73 159094 42003 53147896
Sleep disorder 12.87 9.42 247 158920 58623 53131276
Hyperhidrosis 12.84 9.42 379 158788 96414 53093485
Compulsive shopping 12.78 9.42 14 159153 812 53189087
Brain contusion 12.78 9.42 12 159155 579 53189320
Irritable bowel syndrome 12.75 9.42 77 159090 43555 53146344
No adverse event 12.72 9.42 67 159100 39198 53150701
Feeling abnormal 12.72 9.42 509 158658 134792 53055107
Blastocystis infection 12.69 9.42 4 159163 17 53189882
Victim of child abuse 12.69 9.42 4 159163 17 53189882
Sleep terror 12.59 9.42 14 159153 826 53189073
Seizure 12.59 9.42 489 158678 129020 53060879
Drug tolerance increased 12.56 9.42 8 159159 215 53189684
Death 12.55 9.42 907 158260 356325 52833574
Periventricular leukomalacia 12.54 9.42 6 159161 90 53189809
Accidental exposure to product 12.52 9.42 33 159134 23641 53166258
Intravascular haemolysis 12.51 9.42 9 159158 297 53189602
Peptic ulcer 12.47 9.42 34 159133 4166 53185733
Septic shock 12.45 9.42 122 159045 62107 53127792
Blood pressure systolic abnormal 12.42 9.42 3 159164 7136 53182763
Benzodiazepine drug level 12.38 9.42 3 159164 3 53189896
Suicidal behaviour 12.30 9.42 25 159142 2533 53187366
Blepharospasm 12.29 9.42 26 159141 2710 53187189
Theft 12.25 9.42 6 159161 95 53189804
Haemophagocytic lymphohistiocytosis 12.18 9.42 6 159161 9131 53180768
Mood altered 12.12 9.42 77 159090 13824 53176075
Speech disorder 12.12 9.42 174 158993 39007 53150892
Drug diversion 12.07 9.42 14 159153 865 53189034
Social anxiety disorder 12.02 9.42 10 159157 410 53189489
Crime 12.00 9.42 4 159163 21 53189878
Diarrhoea 11.98 9.42 1660 157507 623886 52566013
Diabetic ketoacidosis 11.93 9.42 26 159141 19889 53170010
Dysphagia 11.90 9.42 333 158834 84064 53105835
Gun shot wound 11.71 9.42 6 159161 105 53189794
Transplant rejection 11.64 9.42 8 159159 10143 53179756
Urinary hesitation 11.60 9.42 22 159145 2119 53187780
Toxic epidermal necrolysis 11.59 9.42 34 159133 23516 53166383
Fibrocystic breast disease 11.54 9.42 16 159151 1184 53188715
Left ventricular hypertrophy 11.46 9.42 38 159129 5185 53184714
Self-medication 11.46 9.42 24 159143 2484 53187415
Automatism 11.37 9.42 5 159162 61 53189838
Drug dependence, antepartum 11.29 9.42 4 159163 26 53189873
Myelosuppression 11.24 9.42 13 159154 12815 53177084
Balance disorder 11.22 9.42 292 158875 72915 53116984
Alcohol poisoning 11.12 9.42 20 159147 1849 53188050
Bronchopulmonary aspergillosis 11.09 9.42 6 159161 8659 53181240
Tension 11.08 9.42 28 159139 3278 53186621
Bone scan abnormal 11.01 9.42 9 159158 360 53189539
Waxy flexibility 11.00 9.42 6 159161 120 53189779
Anal incontinence 10.99 9.42 70 159097 12577 53177322
Dysuria 10.97 9.42 139 159028 30314 53159585
Vertigo CNS origin 10.92 9.42 4 159163 29 53189870
Type 2 diabetes mellitus 10.85 9.42 53 159114 31617 53158282
Foetal exposure during pregnancy 10.82 9.42 60 159107 34655 53155244
Enthesopathy 10.82 9.42 3 159164 6508 53183391
Peritoneal perforation 10.82 9.42 6 159161 124 53189775
Liver injury 10.81 9.42 32 159135 22071 53167828
Bradycardia 10.77 9.42 283 158884 70773 53119126
Muscle tone disorder 10.74 9.42 6 159161 126 53189773
Restless legs syndrome 10.73 9.42 88 159079 17135 53172764
Eustachian tube disorder 10.69 9.42 5 159162 71 53189828
Mouth ulceration 10.68 9.42 48 159119 29278 53160621
Multiple sclerosis 10.67 9.42 126 159041 27027 53162872
Panniculitis 10.62 9.42 5 159162 7809 53182090
Respiratory disorder 10.59 9.42 59 159108 34038 53155861
Dermatitis allergic 10.59 9.42 15 159152 13553 53176346
Asthenia 10.53 9.42 1175 157992 342415 52847484
Haemangioma congenital 10.48 9.42 10 159157 492 53189407
Nasal congestion 10.43 9.42 105 159062 53182 53136717
Middle insomnia 10.40 9.42 61 159106 10647 53179252
Adverse drug reaction 10.36 9.42 106 159061 53519 53136380
Neurologic neglect syndrome 10.31 9.42 15 159152 1160 53188739
Immunodeficiency 10.30 9.42 18 159149 14949 53174950
Deep vein thrombosis 10.29 9.42 322 158845 82591 53107308
Respiratory acidosis 10.25 9.42 42 159125 6346 53183553
Prothrombin time prolonged 10.23 9.42 57 159110 9765 53180134
Eating disorder 10.22 9.42 83 159084 16114 53173785
Dysphoria 10.07 9.42 37 159130 5312 53184587
Psychotic behaviour 10.07 9.42 11 159156 636 53189263
Respiratory dyskinesia 10.07 9.42 4 159163 37 53189862
Trance 10.07 9.42 4 159163 37 53189862
Thirst 10.04 9.42 64 159103 11502 53178397
Poor venous access 10.00 9.42 9 159158 9966 53179933
Blood potassium decreased 9.98 9.42 173 158994 40287 53149612
Dreamy state 9.98 9.42 4 159163 38 53189861
Tuberculosis 9.94 9.42 11 159156 11060 53178839
Lethargy 9.92 9.42 220 158947 53540 53136359
Secretion discharge 9.92 9.42 10 159157 10496 53179403
Spondylolisthesis 9.85 9.42 27 159140 3318 53186581
Apallic syndrome 9.85 9.42 11 159156 652 53189247
Acute kidney injury 9.83 9.42 639 158528 253229 52936670
Spleen congestion 9.81 9.42 6 159161 150 53189749
Eye movement disorder 9.75 9.42 35 159132 4970 53184929
Emotional poverty 9.72 9.42 8 159159 323 53189576
Pulmonary fibrosis 9.72 9.42 38 159129 24097 53165802
Proteinuria 9.70 9.42 25 159142 18043 53171856
Sensory loss 9.70 9.42 48 159119 7857 53182042
Coordination abnormal 9.69 9.42 65 159102 11886 53178013
Sedation 9.67 9.42 133 159034 29542 53160357
Bipolar disorder 9.66 9.42 47 159120 7639 53182260
Oophorectomy bilateral 9.63 9.42 4 159163 42 53189857
Device difficult to use 9.62 9.42 10 159157 10349 53179550
Therapeutic response unexpected 9.59 9.42 86 159081 17184 53172715
Communication disorder 9.49 9.42 22 159145 2439 53187460
Labelled drug-food interaction issue 9.47 9.42 3 159164 13 53189886

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
Completed suicide 869.89 10.13 1188 91350 91329 32329659
Somnambulism 651.99 10.13 270 92268 2962 32418026
Drug abuse 418.00 10.13 788 91750 79455 32341533
Drug dependence 413.95 10.13 417 92121 23067 32397921
Intentional overdose 351.07 10.13 508 92030 41093 32379895
Amnesia 286.77 10.13 355 92183 24681 32396307
Suicide attempt 247.08 10.13 413 92125 37831 32383157
Toxicity to various agents 242.75 10.13 1076 91462 176965 32244023
Insomnia 235.17 10.13 723 91815 99625 32321363
Intentional self-injury 185.30 10.13 213 92325 13687 32407301
Road traffic accident 159.43 10.13 221 92317 17160 32403828
Off label use 138.25 10.13 431 92107 305889 32115099
Abnormal sleep-related event 136.86 10.13 52 92486 445 32420543
Sopor 135.12 10.13 167 92371 11582 32409406
Poisoning 132.20 10.13 161 92377 10997 32409991
Somnolence 124.62 10.13 605 91933 103192 32317796
Overdose 124.20 10.13 534 92004 86543 32334445
Respiratory arrest 121.60 10.13 260 92278 28648 32392340
Sleep-related eating disorder 119.90 10.13 43 92495 307 32420681
Drug withdrawal syndrome 107.97 10.13 201 92337 20030 32400958
Abnormal behaviour 104.44 10.13 232 92306 26234 32394754
Impaired driving ability 101.29 10.13 72 92466 2447 32418541
Parasomnia 99.97 10.13 39 92499 361 32420627
Delirium 95.31 10.13 309 92229 43737 32377251
Confusional state 94.58 10.13 714 91824 142401 32278587
Suicidal ideation 91.45 10.13 277 92261 37806 32383182
Anxiety 77.47 10.13 503 92035 95502 32325486
Homicide 74.98 10.13 42 92496 931 32420057
Coma 73.19 10.13 277 92261 42335 32378653
Depression 71.99 10.13 498 92040 96562 32324426
Cardio-respiratory arrest 66.13 10.13 325 92213 55664 32365324
Withdrawal syndrome 65.37 10.13 121 92417 12001 32408987
Automatism 65.14 10.13 20 92518 81 32420907
Poisoning deliberate 64.43 10.13 85 92453 6290 32414698
Bradyphrenia 61.78 10.13 71 92467 4558 32416430
Intentional product misuse 61.62 10.13 234 92304 35817 32385171
Product use in unapproved indication 61.13 10.13 96 92442 87108 32333880
Disorientation 57.16 10.13 217 92321 33208 32387780
Suicidal behaviour 56.74 10.13 41 92497 1430 32419558
Gun shot wound 54.29 10.13 36 92502 1090 32419898
Rheumatoid arthritis 52.17 10.13 31 92507 44513 32376475
Aggression 51.12 10.13 235 92303 39154 32381834
Drug use disorder 50.81 10.13 57 92481 3564 32417424
Drug abuser 48.95 10.13 60 92478 4124 32416864
Drug ineffective 48.91 10.13 783 91755 382694 32038294
Prescription form tampering 44.64 10.13 25 92513 554 32420434
Fall 43.48 10.13 792 91746 195409 32225579
Drug tolerance 42.30 10.13 42 92496 2279 32418709
Agitation 41.41 10.13 292 92246 56944 32364044
Anterograde amnesia 41.40 10.13 17 92521 182 32420806
Restlessness 38.86 10.13 157 92381 24724 32396264
Altered state of consciousness 38.59 10.13 144 92394 21853 32399135
Asthma 37.51 10.13 42 92496 44023 32376965
Sleep disorder 37.25 10.13 163 92375 26589 32394399
Nightmare 36.64 10.13 101 92437 13065 32407923
Antidepressant drug level above therapeutic 36.01 10.13 15 92523 167 32420821
Dependence 35.35 10.13 29 92509 1224 32419764
Legal problem 35.31 10.13 15 92523 176 32420812
Mania 35.28 10.13 82 92456 9550 32411438
Irritability 34.93 10.13 151 92387 24503 32396485
Conduction disorder 34.41 10.13 35 92503 1955 32419033
Acute kidney injury 34.14 10.13 609 91929 292859 32128129
Cytomegalovirus infection 33.86 10.13 15 92523 25449 32395539
Angioedema 33.82 10.13 32 92506 36257 32384731
Death 33.60 10.13 831 91707 381686 32039302
Memory impairment 33.16 10.13 213 92325 40266 32380722
Therapeutic product effect incomplete 32.43 10.13 42 92496 41299 32379689
Hallucination 31.61 10.13 257 92281 52362 32368626
Thinking abnormal 31.33 10.13 57 92481 5578 32415410
Exposure via ingestion 31.20 10.13 36 92502 2321 32418667
Initial insomnia 31.11 10.13 41 92497 3031 32417957
Persistent depressive disorder 30.72 10.13 16 92522 305 32420683
Analgesic drug level above therapeutic 30.61 10.13 15 92523 250 32420738
Drug intolerance 30.05 10.13 61 92477 50174 32370814
Joint swelling 29.96 10.13 64 92474 51671 32369317
Loss of consciousness 29.71 10.13 363 92175 82344 32338644
Oedematous pancreatitis 29.71 10.13 18 92520 464 32420524
Self-medication 29.25 10.13 35 92503 2346 32418642
Multiple organ dysfunction syndrome 28.13 10.13 103 92435 69751 32351237
Febrile neutropenia 27.59 10.13 213 92325 119353 32301635
Sepsis 27.56 10.13 304 92234 158530 32262458
Treatment failure 27.53 10.13 43 92495 39120 32381868
Dissociative disorder 27.40 10.13 13 92525 201 32420787
Hypokinesia 26.97 10.13 68 92470 8337 32412651
Personality change 26.65 10.13 50 92488 5009 32415979
Incoherent 26.12 10.13 46 92492 4388 32416600
General physical health deterioration 25.81 10.13 207 92331 115052 32305936
Poor quality sleep 25.58 10.13 65 92473 8009 32412979
Circadian rhythm sleep disorder 25.23 10.13 16 92522 448 32420540
Pyrexia 25.18 10.13 706 91832 319262 32101726
Septic shock 25.05 10.13 106 92432 68883 32352105
Lower respiratory tract infection 24.74 10.13 28 92510 29215 32391773
Paranoia 24.46 10.13 77 92461 10722 32410266
Miosis 24.44 10.13 67 92471 8637 32412351
Cardiac arrest 24.39 10.13 399 92139 96377 32324611
Infection 23.99 10.13 142 92396 84573 32336415
Theft 23.71 10.13 13 92525 276 32420712
Logorrhoea 23.61 10.13 32 92506 2430 32418558
Neutropenia 23.14 10.13 276 92262 141899 32279089
Dyspnoea 23.13 10.13 821 91717 361224 32059764
Visceral congestion 22.97 10.13 16 92522 526 32420462
Labelled drug-food interaction medication error 22.95 10.13 8 92530 52 32420936
Thermophobia 22.64 10.13 9 92529 88 32420900
Disturbance in attention 22.63 10.13 130 92408 23623 32397365
Abnormal dreams 22.17 10.13 64 92474 8500 32412488
Erythema 22.12 10.13 142 92396 82963 32338025
Bradypnoea 21.88 10.13 31 92507 2455 32418533
Panic attack 21.87 10.13 67 92471 9194 32411794
Depressed level of consciousness 21.63 10.13 194 92344 40653 32380335
Cardiac failure 21.28 10.13 163 92375 91510 32329478
Drug withdrawal convulsions 20.96 10.13 21 92517 1152 32419836
Acute stress disorder 20.83 10.13 10 92528 159 32420829
Myelosuppression 20.77 10.13 4 92534 11672 32409316
Akathisia 20.66 10.13 55 92483 6970 32414018
Sleep apnoea syndrome 20.64 10.13 107 92431 18707 32402281
Anger 20.11 10.13 77 92461 11827 32409161
Victim of chemical submission 19.89 10.13 7 92531 47 32420941
Infusion related reaction 19.86 10.13 65 92473 45534 32375454
Hallucination, visual 19.81 10.13 99 92439 17060 32403928
Reduced facial expression 19.56 10.13 18 92520 888 32420100
Distributive shock 19.40 10.13 18 92520 897 32420091
Alcohol interaction 19.35 10.13 28 92510 2261 32418727
Mental status changes 18.75 10.13 179 92359 38158 32382830
Intentional product use issue 18.50 10.13 60 92478 42151 32378837
Tachyphrenia 18.49 10.13 20 92518 1200 32419788
Stress at work 18.20 10.13 9 92529 153 32420835
Drug screen positive 17.65 10.13 38 92500 4203 32416785
Impatience 17.54 10.13 11 92527 302 32420686
Major depression 17.41 10.13 39 92499 4432 32416556
Perseveration 17.26 10.13 8 92530 117 32420871
Pruritus 17.24 10.13 260 92278 128442 32292546
Renal impairment 17.16 10.13 173 92365 91799 32329189
Peripheral swelling 17.07 10.13 119 92419 68226 32352762
Synovitis 16.85 10.13 5 92533 10873 32410115
Asphyxia 16.62 10.13 44 92494 5556 32415432
Transplant rejection 16.61 10.13 4 92534 9995 32410993
COVID-19 16.60 10.13 42 92496 31973 32389015
Loss of personal independence in daily activities 16.55 10.13 32 92506 26801 32394187
Rectal haemorrhage 16.54 10.13 53 92485 37370 32383618
Victim of homicide 16.45 10.13 8 92530 131 32420857
Oral discharge 16.18 10.13 8 92530 136 32420852
Cough 16.10 10.13 288 92250 138529 32282459
Libido decreased 16.01 10.13 39 92499 4679 32416309
Brachial plexus injury 15.98 10.13 7 92531 89 32420899
Apallic syndrome 15.93 10.13 10 92528 275 32420713
Drug diversion 15.80 10.13 16 92522 889 32420099
Sexual abuse 15.72 10.13 8 92530 145 32420843
Condition aggravated 15.61 10.13 331 92207 155330 32265658
Euphoric mood 15.45 10.13 41 92497 5186 32415802
Drug resistance 15.40 10.13 26 92512 22939 32398049
Galactorrhoea 15.26 10.13 11 92527 382 32420606
Skin laceration 15.22 10.13 71 92467 11895 32409093
Adrenocorticotropic hormone deficiency 15.15 10.13 13 92525 584 32420404
Hallucination, auditory 15.12 10.13 64 92474 10286 32410702
Nervousness 15.12 10.13 73 92465 12406 32408582
Sleep talking 14.82 10.13 12 92526 497 32420491
Pulmonary fibrosis 14.64 10.13 16 92522 16958 32404030
Neurotoxicity 14.38 10.13 13 92525 15057 32405931
Dysarthria 14.29 10.13 151 92387 33050 32387938
Acute myocardial infarction 14.28 10.13 95 92443 55054 32365934
Tubulointerstitial nephritis 14.23 10.13 21 92517 19556 32401432
Amimia 14.20 10.13 4 92534 11 32420977
Coagulation factor VII level decreased 14.16 10.13 7 92531 119 32420869
Product dose omission issue 14.15 10.13 206 92332 102369 32318619
Pneumothorax traumatic 13.79 10.13 6 92532 75 32420913
Sciatic nerve neuropathy 13.65 10.13 6 92532 77 32420911
Aspergillus infection 13.62 10.13 8 92530 11566 32409422
Dry mouth 13.52 10.13 116 92422 24003 32396985
Psychomotor skills impaired 13.51 10.13 25 92513 2478 32418510
Leukopenia 13.44 10.13 108 92430 60014 32360974
C-reactive protein increased 13.41 10.13 81 92457 48021 32372967
Psychomotor hyperactivity 13.29 10.13 56 92482 8983 32412005
Hangover 13.24 10.13 16 92522 1083 32419905
Disinhibition 13.24 10.13 26 92512 2694 32418294
Toxic epidermal necrolysis 13.19 10.13 24 92514 20569 32400419
Respiratory failure 13.18 10.13 220 92318 106962 32314026
Differentiation syndrome 13.12 10.13 17 92521 1236 32419752
Heart rate decreased 13.11 10.13 33 92505 25167 32395821
Drug tolerance increased 13.09 10.13 11 92527 480 32420508
Victim of crime 13.09 10.13 10 92528 380 32420608
Electrocardiogram J wave 13.07 10.13 4 92534 16 32420972
Psychotic disorder 13.05 10.13 111 92427 22909 32398079
Hypogonadism 12.98 10.13 20 92518 1707 32419281
Ataxia 12.97 10.13 71 92467 12670 32408318
Hyperlipidaemia 12.90 10.13 78 92460 14433 32406555
Inappropriate antidiuretic hormone secretion 12.81 10.13 68 92470 11995 32408993
Psoriasis 12.68 10.13 78 92460 46045 32374943
Imprisonment 12.67 10.13 11 92527 502 32420486
Alcohol use 12.61 10.13 29 92509 3354 32417634
Slow speech 12.48 10.13 15 92523 1010 32419978
Sciatic nerve injury 12.35 10.13 6 92532 98 32420890
Hypersensitivity 12.34 10.13 105 92433 57653 32363335
Grandiosity 12.21 10.13 9 92529 324 32420664
Drowning 12.19 10.13 10 92528 422 32420566
Congenital hydrocephalus 12.08 10.13 6 92532 103 32420885
Neutropenic sepsis 12.06 10.13 11 92527 12688 32408300
Bradykinesia 12.04 10.13 33 92505 4253 32416735
Family stress 11.96 10.13 7 92531 169 32420819
Hospitalisation 11.87 10.13 86 92452 48885 32372103
Mucosal inflammation 11.75 10.13 52 92486 33382 32387606
Accidental poisoning 11.73 10.13 11 92527 556 32420432
Mental disorder due to a general medical condition 11.67 10.13 7 92531 177 32420811
Thrombocytopenia 11.67 10.13 327 92211 147972 32273016
Feeling abnormal 11.66 10.13 239 92299 60184 32360804
Drug withdrawal syndrome neonatal 11.61 10.13 29 92509 3535 32417453
Urticaria 11.59 10.13 111 92427 59503 32361485
Blood pressure fluctuation 11.57 10.13 25 92513 20110 32400878
Diarrhoea 11.57 10.13 888 91650 363914 32057074
Myocardial infarction 11.52 10.13 271 92267 125405 32295583
Epstein-Barr virus infection 11.46 10.13 3 92535 7087 32413901
Cholestasis 11.45 10.13 39 92499 26994 32393994
Blood pressure increased 11.43 10.13 158 92380 79196 32341792
Wheezing 11.41 10.13 60 92478 36814 32384174
Spigelian hernia 11.32 10.13 3 92535 6 32420982
Bronchiectasis 11.23 10.13 3 92535 6989 32413999
Anaphylactic reaction 11.17 10.13 46 92492 30126 32390862
Coprolalia 11.10 10.13 4 92534 29 32420959
Poor feeding infant 11.08 10.13 10 92528 481 32420507
Amnestic disorder 11.07 10.13 7 92531 195 32420793
Neutrophil count increased 11.03 10.13 18 92520 16096 32404892
Pilonidal cyst congenital 10.98 10.13 4 92534 30 32420958
Substance-induced mood disorder 10.98 10.13 5 92533 70 32420918
Urinary hesitation 10.94 10.13 22 92516 2319 32418669
Bone marrow failure 10.85 10.13 47 92491 30357 32390631
Renal injury 10.80 10.13 11 92527 12044 32408944
Hyperhidrosis 10.77 10.13 272 92266 70896 32350092
Lactic acidosis 10.70 10.13 54 92484 33482 32387506
Thrombotic microangiopathy 10.54 10.13 7 92531 9475 32411513
Staring 10.54 10.13 17 92521 1509 32419479
Product substitution issue 10.52 10.13 58 92480 10378 32410610
Labile hypertension 10.50 10.13 5 92533 78 32420910
Rash 10.46 10.13 488 92050 208845 32212143
Drug half-life reduced 10.46 10.13 3 92535 9 32420979
Lethargy 10.38 10.13 170 92368 41058 32379930
Labelled drug-drug interaction medication error 10.37 10.13 12 92526 12401 32408587
Tuberculosis 10.32 10.13 6 92532 8723 32412265
Scar pain 10.22 10.13 5 92533 83 32420905

Pharmacologic Action:

SourceCodeDescription
ATC N05CF02 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine related drugs
FDA CS M0018233 Pyridines
FDA MoA N0000000196 GABA A Agonists
FDA Chemical/Ingredient N0000007570 Pyridines
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018755 GABA Agonists
MeSH PA D058785 GABA-A Receptor Agonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D000068776 Sleep Aids, Pharmaceutical
CHEBI has role CHEBI:35488 CNS depressants
CHEBI has role CHEBI:35717 sedatives
CHEBI has role CHEBI:51373 gamma-aminobutyric acid receptor agonists
FDA PE N0000175728 Central Nervous System Depression
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Initial insomnia indication 59050008
Insomnia indication 193462001
Cognitive impairment following traumatic brain injury off-label use 127295002
Arousal post traumatic brain injury off-label use 127295002
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Asthenia contraindication 13791008
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Aggressive behavior contraindication 61372001
Substance abuse contraindication 66214007
Sleep apnea contraindication 73430006 DOID:0050847
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Severe chronic obstructive pulmonary disease contraindication 313299006
Impaired cognition contraindication 386806002
Memory impairment contraindication 386807006
Attention deficit hyperactivity disorder contraindication 406506008

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.73 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.75MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7682628 Feb. 16, 2025 METHOD FOR TREATING INSOMNIA
3.5MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7682628 Feb. 16, 2025 METHOD FOR TREATING INSOMNIA
10MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9597281 April 6, 2027 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9597281 April 6, 2027 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
1.75MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7658945 April 15, 2027 METHOD FOR TREATING INSOMNIA
3.5MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7658945 April 15, 2027 METHOD FOR TREATING INSOMNIA
1.75MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 8242131 Aug. 20, 2029 METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
3.5MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 8242131 Aug. 20, 2029 METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
10MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9265720 Feb. 25, 2031 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9265720 Feb. 25, 2031 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG/SPRAY ZOLPIMIST AYTU N022196 Dec. 19, 2008 RX SPRAY, METERED ORAL 8236285 Aug. 7, 2032 TREATMENT OF TRANSIENT INSOMNIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel ALLOSTERIC MODULATOR Ki 7.68 IUPHAR IUPHAR
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR EC50 6.70 WOMBAT-PK CHEMBL
GABA-A receptor alpha-2/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.81 WOMBAT-PK CHEMBL
GABA-A receptor alpha-3/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.42 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.57 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.16 WOMBAT-PK CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel Ki 6.39 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-3 Ion channel Ki 6.01 CHEMBL
Multidrug resistance protein 1 Transporter Km 3.70 WOMBAT-PK
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel Ki 6.12 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-5 Ion channel Ki 7.46 CHEMBL
GABA A receptor alpha-6/beta-2/gamma-2 Ion channel Ki 6.01 CHEMBL
GABA-A receptor; alpha-1/beta-2/gamma-2 Ion channel Ki 7.72 CHEMBL
GABA A receptor alpha-2/beta-2/gamma-2 Ion channel Ki 6.81 CHEMBL
CAAX prenyl protease 2 Enzyme AC50 4.77 CHEMBL
GABA-A receptor; anion channel Ion channel Ki 7.60 CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel Ki 6.42 CHEMBL
Translocator protein Membrane receptor IC50 5.33 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel Ki 7.30 CHEMBL

External reference:

IDSource
D00706 KEGG_DRUG
99294-93-6 SECONDARY_CAS_RN
4020811 VANDF
4023596 VANDF
C0078839 UMLSCUI
CHEBI:10125 CHEBI
CHEMBL911 ChEMBL_ID
CHEMBL3989820 ChEMBL_ID
DB00425 DRUGBANK_ID
CHEMBL1723343 ChEMBL_ID
D000077334 MESH_DESCRIPTOR_UI
5732 PUBCHEM_CID
4348 IUPHAR_LIGAND_ID
5741 INN_ID
7K383OQI23 UNII
131725 RXNORM
109404 MMSL
343 MMSL
5713 MMSL
d00910 MMSL
004146 NDDF
004147 NDDF
387569009 SNOMEDCT_US
395928005 SNOMEDCT_US
96231005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5401 TABLET, FILM COATED 5 mg ORAL NDA 33 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5421 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5501 TABLET, COATED 6.25 mg ORAL NDA 33 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5521 TABLET, COATED 12.50 mg ORAL NDA 33 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6010 TABLET 10 mg ORAL NDA 33 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6050 TABLET 5 mg ORAL NDA 33 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0086 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0087 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0073 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0074 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8225 TABLET, FILM COATED 5 mg ORAL ANDA 32 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8226 TABLET, FILM COATED 10 mg ORAL ANDA 32 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5315 TABLET, EXTENDED RELEASE 6.25 mg ORAL ANDA 32 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5316 TABLET, EXTENDED RELEASE 12.50 mg ORAL ANDA 32 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5317 TABLET, COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5318 TABLET, COATED 10 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6082 TABLET 5 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6083 TABLET 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0955-1702 TABLET, FILM COATED, EXTENDED RELEASE 6.25 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0955-1703 TABLET, FILM COATED, EXTENDED RELEASE 12.50 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Zolpidem TartrateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-116 TABLET, FILM COATED, EXTENDED RELEASE 12.50 mg ORAL ANDA 32 sections
Zolpidem TartrateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-117 TABLET, FILM COATED, EXTENDED RELEASE 6.25 mg ORAL ANDA 32 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 10544-040 TABLET 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-539 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-540 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-548 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 12634-943 TABLET 5 mg ORAL ANDA 14 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 12634-944 TABLET 10 mg ORAL ANDA 14 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-007 TABLET 5 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-008 TABLET 10 mg ORAL ANDA 31 sections