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 1420.72 9.34 2045 150198 143875 46389944
Drug abuse 682.85 9.34 934 151309 62474 46471345
Intentional overdose 583.84 9.34 878 151365 64066 46469753
Toxicity to various agents 538.18 9.34 1714 150529 210052 46323767
Somnambulism 502.52 9.34 270 151973 4767 46529052
Drug dependence 440.90 9.34 426 151817 19475 46514344
Suicide attempt 424.95 9.34 694 151549 54342 46479477
Rheumatoid arthritis 365.73 9.34 163 152080 240052 46293767
Amnesia 365.65 9.34 557 151686 41074 46492745
Sopor 292.58 9.34 342 151901 19486 46514333
Intentional self-injury 267.47 9.34 361 151882 23805 46510014
Overdose 256.11 9.34 823 151420 101156 46432663
Insomnia 225.24 9.34 1099 151144 163825 46369994
Abnormal sleep-related event 212.32 9.34 83 152160 664 46533155
Drug intolerance 203.64 9.34 113 152130 146936 46386883
Coma 203.59 9.34 530 151713 57819 46476000
Contraindicated product administered 179.64 9.34 24 152219 79923 46453896
Treatment failure 176.74 9.34 43 152200 93044 46440775
Drug ineffective 171.83 9.34 1403 150840 676435 45857384
Sleep-related eating disorder 166.19 9.34 66 152177 553 46533266
Anxiety 163.99 9.34 1085 151158 180872 46352947
Joint swelling 158.27 9.34 185 152058 165888 46367931
Drug withdrawal syndrome 157.86 9.34 304 151939 27080 46506739
Poisoning deliberate 157.59 9.34 160 152083 7766 46526053
Synovitis 150.80 9.34 13 152230 61062 46472757
Somnolence 143.82 9.34 938 151305 155583 46378236
Cardio-respiratory arrest 143.72 9.34 476 151767 59393 46474426
Off label use 137.84 9.34 704 151539 379137 46154682
Depression 137.06 9.34 987 151256 169117 46364702
Infusion related reaction 136.87 9.34 80 152163 101128 46432691
Poisoning 135.37 9.34 196 152047 13798 46520021
Intentional product misuse 134.60 9.34 398 151845 46730 46487089
Respiratory arrest 130.27 9.34 319 151924 33497 46500322
Suicidal ideation 108.52 9.34 417 151826 55965 46477854
Peripheral swelling 100.13 9.34 230 152013 157841 46375978
Confusional state 99.80 9.34 875 151368 159017 46374802
Road traffic accident 98.25 9.34 230 152013 23461 46510358
Mydriasis 98.01 9.34 145 152098 10408 46523411
Hand deformity 95.43 9.34 4 152239 34570 46499249
Abnormal behaviour 94.59 9.34 211 152032 20847 46512972
Drug hypersensitivity 94.58 9.34 441 151802 243384 46290435
Impaired driving ability 92.72 9.34 90 152153 4134 46529685
Fall 87.19 9.34 1532 150711 327565 46206254
Systemic lupus erythematosus 86.02 9.34 53 152190 65127 46468692
Arthropathy 85.40 9.34 90 152153 84610 46449209
Loss of consciousness 84.18 9.34 623 151620 107615 46426204
Lower respiratory tract infection 78.13 9.34 41 152202 55048 46478771
Maternal exposure during pregnancy 78.00 9.34 134 152109 102415 46431404
Arthralgia 76.95 9.34 789 151454 363814 46170005
Hypersensitivity 75.48 9.34 245 151998 150076 46383743
Withdrawal syndrome 75.14 9.34 176 152067 17958 46515861
Agitation 74.55 9.34 368 151875 55047 46478772
Disorientation 74.29 9.34 277 151966 36641 46497178
Restlessness 72.32 9.34 215 152028 25309 46508510
Nasopharyngitis 71.22 9.34 260 151983 153738 46380081
Exposure via ingestion 70.77 9.34 71 152172 3396 46530423
Homicide 68.37 9.34 32 152211 414 46533405
Infection 62.79 9.34 224 152019 133368 46400451
Delirium 60.24 9.34 261 151982 36967 46496852
Miosis 59.71 9.34 90 152153 6567 46527252
Therapeutic product effect incomplete 59.53 9.34 102 152141 78051 46455768
Product substitution issue 58.09 9.34 142 152101 14889 46518930
Drug abuser 56.63 9.34 61 152182 3172 46530647
Bradypnoea 56.17 9.34 59 152184 2980 46530839
Rash 56.01 9.34 822 151421 355690 46178129
Cardiac arrest 55.44 9.34 493 151750 89906 46443913
Mental status changes 52.69 9.34 255 151988 37833 46495986
Musculoskeletal stiffness 51.78 9.34 156 152087 97837 46435982
Alopecia 51.11 9.34 315 151928 162099 46371720
Disturbance in attention 50.10 9.34 220 152023 31340 46502479
Sleep talking 50.01 9.34 34 152209 933 46532886
Glossodynia 49.56 9.34 43 152200 44330 46489489
Cough 46.94 9.34 502 151741 229747 46304072
Swelling 45.41 9.34 230 152013 124281 46409538
Prescription form tampering 45.22 9.34 28 152215 652 46533167
Myocardial depression 44.51 9.34 25 152218 483 46533336
Mental disorder 44.06 9.34 167 152076 22258 46511561
Product use in unapproved indication 43.99 9.34 149 152094 90124 46443695
Akathisia 43.66 9.34 85 152158 7629 46526190
Drug use disorder 43.40 9.34 49 152194 2686 46531133
Exposure during pregnancy 42.90 9.34 194 152049 108018 46425801
Abdominal discomfort 42.61 9.34 303 151940 150862 46382957
Hallucination 42.56 9.34 294 151949 49657 46484162
Bradyphrenia 41.98 9.34 74 152169 6156 46527663
Psychomotor skills impaired 41.41 9.34 43 152200 2143 46531676
Substance abuse 41.23 9.34 59 152184 4108 46529711
Therapeutic product effect decreased 41.17 9.34 135 152108 82466 46451353
Decorticate posture 40.74 9.34 21 152222 339 46533480
Dependence 40.25 9.34 40 152203 1891 46531928
Drug tolerance 40.13 9.34 51 152192 3167 46530652
Hallucination, visual 39.25 9.34 138 152105 17735 46516084
Device expulsion 38.31 9.34 21 152222 27521 46506298
Altered state of consciousness 37.24 9.34 163 152080 23185 46510634
Anaphylactic reaction 37.16 9.34 73 152170 53039 46480780
Tremor 36.69 9.34 555 151688 115084 46418735
Product use issue 36.13 9.34 172 152071 94472 46439347
Immobilisation prolonged 35.44 9.34 12 152231 60 46533759
Drug detoxification 35.40 9.34 16 152227 190 46533629
Premature delivery 35.06 9.34 14 152229 22055 46511764
Victim of sexual abuse 35.02 9.34 22 152221 526 46533293
Depressed level of consciousness 34.80 9.34 270 151973 47299 46486520
Illusion 34.13 9.34 28 152215 1028 46532791
Logorrhoea 33.64 9.34 40 152203 2319 46531500
High risk sexual behaviour 33.10 9.34 7 152236 0 46533819
Tachycardia 32.72 9.34 481 151762 99141 46434678
Injury 31.71 9.34 249 151994 43778 46490041
Wound 31.55 9.34 57 152186 42745 46491074
Anterograde amnesia 31.14 9.34 18 152225 368 46533451
Pericarditis 30.81 9.34 20 152223 23907 46509912
Victim of chemical submission 30.36 9.34 16 152227 271 46533548
Memory impairment 30.12 9.34 385 151858 76952 46456867
Parasomnia 29.94 9.34 18 152225 397 46533422
Accidental overdose 28.95 9.34 136 152107 19930 46513889
Neutropenia 28.84 9.34 313 151930 142891 46390928
Aggression 28.44 9.34 148 152095 22596 46511223
Parkinsonism hyperpyrexia syndrome 28.35 9.34 13 152230 160 46533659
Red blood cell sedimentation rate increased 28.31 9.34 20 152223 22869 46510950
Condition aggravated 28.17 9.34 597 151646 244455 46289364
Arthritis 27.51 9.34 144 152099 77172 46456647
Affect lability 27.07 9.34 72 152171 7948 46525871
Irritability 26.83 9.34 174 152069 28772 46505047
Dyspnoea 26.72 9.34 1392 150851 514156 46019663
Drug withdrawal convulsions 26.53 9.34 27 152216 1314 46532505
Chemical submission 26.52 9.34 14 152229 238 46533581
Panic attack 26.20 9.34 133 152110 20109 46513710
Erythema 26.09 9.34 319 151924 142501 46391318
Pneumonia 26.06 9.34 984 151259 375336 46158483
Drug resistance 26.02 9.34 12 152231 17356 46516463
Blood pressure fluctuation 25.78 9.34 37 152206 30411 46503408
Drop attacks 25.42 9.34 20 152223 691 46533128
Mania 24.91 9.34 85 152158 10761 46523058
Tardive dyskinesia 24.74 9.34 67 152176 7476 46526343
Coma scale abnormal 24.58 9.34 52 152191 4954 46528865
Nightmare 23.58 9.34 112 152131 16486 46517333
Renal impairment 23.49 9.34 144 152099 74228 46459591
Hypokalaemia 22.91 9.34 409 151834 87615 46446204
Urticaria 22.81 9.34 260 151983 117632 46416187
Hallucination, auditory 22.72 9.34 82 152161 10674 46523145
Dysarthria 22.71 9.34 204 152039 37294 46496525
Death 22.64 9.34 880 151363 334668 46199151
Herpes zoster 22.18 9.34 130 152113 67742 46466077
Drug screen positive 22.17 9.34 43 152200 3848 46529971
Pain 22.06 9.34 1302 150941 475646 46058173
Hangover 21.93 9.34 24 152219 1271 46532548
Alcohol abuse 21.85 9.34 31 152212 2141 46531678
Head injury 21.57 9.34 146 152097 24490 46509329
Major depression 21.52 9.34 59 152184 6631 46527188
Blood pressure systolic increased 21.52 9.34 38 152205 28749 46505070
Multiple sclerosis relapse 21.48 9.34 221 152022 41904 46491915
Behaviour disorder 21.24 9.34 29 152214 1932 46531887
Incoherent 21.15 9.34 46 152197 4466 46529353
Hepatic enzyme increased 20.63 9.34 169 152074 81618 46452201
Administration site discomfort 20.44 9.34 9 152234 100 46533719
Initial insomnia 20.43 9.34 45 152198 4407 46529412
Imprisonment 20.38 9.34 11 152232 196 46533623
Mobility decreased 20.37 9.34 115 152128 60479 46473340
C-reactive protein increased 20.35 9.34 110 152133 58480 46475339
Electrocardiogram QT prolonged 20.19 9.34 256 151987 51069 46482750
Tracheal atresia 20.12 9.34 6 152237 18 46533801
Wheezing 19.80 9.34 98 152145 53288 46480531
Asthma 19.67 9.34 197 152046 91345 46442474
Amnestic disorder 19.32 9.34 12 152231 281 46533538
Respiratory depression 19.28 9.34 82 152161 11518 46522301
Pyrexia 19.13 9.34 936 151307 347866 46185953
Obstructive airways disorder 18.98 9.34 10 152233 13402 46520417
Psychomotor retardation 18.76 9.34 36 152207 3197 46530622
Sleep disorder 18.66 9.34 234 152009 46561 46487258
Cytomegalovirus infection 18.59 9.34 19 152224 18125 46515694
Pruritus 18.03 9.34 628 151615 241724 46292095
Psychotic disorder 18.01 9.34 131 152112 22490 46511329
Crying 17.74 9.34 124 152119 21017 46512802
Coagulation factor V level decreased 17.53 9.34 12 152231 333 46533486
Rhabdomyolysis 17.33 9.34 211 152032 41698 46492121
Influenza 17.21 9.34 197 152046 89073 46444746
Derailment 17.09 9.34 7 152236 64 46533755
Malaise 16.97 9.34 895 151348 330337 46203482
Vertigo 16.96 9.34 251 151992 51797 46482022
Bulimia nervosa 16.67 9.34 14 152229 531 46533288
Unresponsive to stimuli 16.50 9.34 169 152074 32005 46501814
Hyponatraemia 16.47 9.34 440 151803 100892 46432927
Femoral neck fracture 16.46 9.34 61 152182 8042 46525777
Urinary retention 16.41 9.34 143 152100 25918 46507901
No adverse event 16.33 9.34 57 152186 34174 46499645
Ventricular hypokinesia 16.26 9.34 39 152204 4039 46529780
Listless 16.14 9.34 26 152217 2009 46531810
Productive cough 16.11 9.34 98 152145 50617 46483202
Inappropriate schedule of product administration 16.10 9.34 135 152108 64878 46468941
Emotional distress 16.08 9.34 162 152081 30545 46503274
Diplopia 15.81 9.34 113 152130 19292 46514527
Terminal insomnia 15.78 9.34 13 152230 480 46533339
Rheumatoid nodule 15.56 9.34 5 152238 9015 46524804
Legal problem 15.47 9.34 5 152238 21 46533798
Injection site reaction 15.45 9.34 92 152151 47757 46486062
Protrusion tongue 15.41 9.34 11 152232 327 46533492
Feeling drunk 15.31 9.34 37 152206 3850 46529969
Autonomic nervous system imbalance 15.30 9.34 28 152215 2398 46531421
Extrapyramidal disorder 15.26 9.34 75 152168 11193 46522626
Pulmonary vasculitis 15.24 9.34 6 152237 49 46533770
Aortic valve calcification 15.24 9.34 12 152231 415 46533404
Generalised tonic-clonic seizure 15.14 9.34 145 152098 26977 46506842
Diarrhoea 14.90 9.34 1598 150645 558004 45975815
Septic shock 14.89 9.34 119 152124 57774 46476045
Mucosal inflammation 14.77 9.34 71 152172 38905 46494914
Loss of proprioception 14.73 9.34 11 152232 351 46533468
Angioedema 14.71 9.34 72 152171 39270 46494549
Prothrombin time shortened 14.68 9.34 23 152220 1736 46532083
Acute kidney injury 14.50 9.34 625 151618 235230 46298589
Abnormal dreams 14.34 9.34 69 152174 10210 46523609
Panic disorder 14.23 9.34 28 152215 2533 46531286
Incomplete spinal fusion 14.19 9.34 3 152240 0 46533819
Facial nerve disorder 14.13 9.34 13 152230 558 46533261
Injection site pain 14.12 9.34 255 151988 106897 46426922
Blepharospasm 14.03 9.34 26 152217 2248 46531571
Dissociative disorder 13.91 9.34 8 152235 162 46533657
Lactic acidosis 13.90 9.34 60 152183 33849 46499970
Accidental exposure to product 13.87 9.34 30 152213 21051 46512768
Intentional product use issue 13.80 9.34 108 152135 52672 46481147
Poor sucking reflex 13.69 9.34 8 152235 167 46533652
Hypothermia 13.69 9.34 77 152166 12106 46521713
Toxic epidermal necrolysis 13.61 9.34 33 152210 22245 46511574
Accidental poisoning 13.48 9.34 13 152230 592 46533227
Inadequate analgesia 13.48 9.34 29 152214 2795 46531024
Foreign body 13.47 9.34 23 152220 1865 46531954
Hip arthroplasty 13.45 9.34 24 152219 18088 46515731
Bone erosion 13.43 9.34 7 152236 9436 46524383
Cognitive disorder 13.27 9.34 181 152062 36702 46497117
Joint range of motion decreased 13.18 9.34 18 152225 15106 46518713
Laryngeal pain 13.09 9.34 39 152204 4595 46529224
Persecutory delusion 13.08 9.34 27 152216 2528 46531291
Pneumonia aspiration 13.01 9.34 159 152084 31446 46502373
Analgesic drug level above therapeutic 12.97 9.34 8 152235 185 46533634
Spinal rod insertion 12.95 9.34 4 152239 14 46533805
Peripheral paralysis 12.93 9.34 6 152237 76 46533743
Theft 12.93 9.34 6 152237 76 46533743
Neonatal behavioural syndrome 12.90 9.34 5 152238 39 46533780
Live birth 12.81 9.34 9 152234 10321 46523498
Diabetic ketoacidosis 12.76 9.34 25 152218 18185 46515634
Frostbite 12.73 9.34 4 152239 15 46533804
Genitourinary symptom 12.66 9.34 6 152237 80 46533739
Prescription drug used without a prescription 12.64 9.34 19 152224 1383 46532436
Product complaint 12.63 9.34 75 152168 12026 46521793
Osteoporosis 12.62 9.34 79 152164 40529 46493290
COVID-19 12.59 9.34 26 152217 18549 46515270
Occupational dermatitis 12.58 9.34 5 152238 42 46533777
Duodenal ulcer perforation 12.54 9.34 6 152237 8496 46525323
Brain contusion 12.49 9.34 12 152231 544 46533275
Intravascular haemolysis 12.45 9.34 9 152234 273 46533546
Decreased interest 12.41 9.34 30 152213 3122 46530697
Transplant rejection 12.38 9.34 8 152235 9588 46524231
Hepatotoxicity 12.36 9.34 41 152202 24968 46508851
Helicobacter infection 12.36 9.34 12 152231 11724 46522095
Victim of child abuse 12.34 9.34 4 152239 17 46533802
Blastocystis infection 12.34 9.34 4 152239 17 46533802
Blood pressure diastolic decreased 12.30 9.34 17 152226 14194 46519625
Neurotoxicity 12.29 9.34 16 152227 13701 46520118
Compulsive shopping 12.20 9.34 14 152229 781 46533038
Haemophagocytic lymphohistiocytosis 12.14 9.34 6 152237 8336 46525483
Benzodiazepine drug level 12.12 9.34 3 152240 3 46533816
Vision blurred 12.07 9.34 343 151900 79365 46454454
Periventricular leukomalacia 12.03 9.34 6 152237 90 46533729
Inappropriate antidiuretic hormone secretion 12.00 9.34 83 152160 14019 46519800
Social anxiety disorder 11.92 9.34 10 152233 379 46533440
Peptic ulcer 11.84 9.34 34 152209 3924 46529895
Inflammation 11.76 9.34 102 152141 48679 46485140
Sinus tachycardia 11.72 9.34 115 152128 21534 46512285
Drug reaction with eosinophilia and systemic symptoms 11.68 9.34 53 152190 29495 46504324
Crime 11.65 9.34 4 152239 21 46533798
Sedation 11.58 9.34 120 152123 22790 46511029
Alcohol use 11.57 9.34 25 152218 2417 46531402
Cholecystitis chronic 11.56 9.34 66 152177 10433 46523386
Suicidal behaviour 11.52 9.34 25 152218 2423 46531396
Multiple injuries 11.51 9.34 22 152221 1947 46531872
Drug dependence, antepartum 11.50 9.34 4 152239 22 46533797
Drug interaction 11.47 9.34 789 151454 202305 46331514
Nasal congestion 11.42 9.34 101 152142 48012 46485807
Bladder sphincter atony 11.42 9.34 7 152236 160 46533659
Muscle tone disorder 11.42 9.34 6 152237 101 46533718
Self-injurious ideation 11.42 9.34 24 152219 2276 46531543
Throat irritation 11.33 9.34 52 152191 28849 46504970
Therapy non-responder 11.33 9.34 83 152160 41069 46492750
Dehydration 11.26 9.34 632 151611 158908 46374911
Multiple organ dysfunction syndrome 11.22 9.34 111 152132 51599 46482220
Gun shot wound 11.16 9.34 6 152237 106 46533713
Waxy flexibility 11.11 9.34 6 152237 107 46533712
Contusion 11.00 9.34 368 151875 87119 46446700
Dermatitis allergic 10.98 9.34 15 152228 12588 46521231
Automatism 10.94 9.34 5 152238 61 46533758
Blister 10.90 9.34 93 152150 44538 46489281
Bone scan abnormal 10.87 9.34 10 152233 429 46533390
Speech disorder 10.85 9.34 172 152071 35995 46497824
Sleep terror 10.70 9.34 13 152230 771 46533048
Bone marrow failure 10.69 9.34 55 152188 29614 46504205
Mouth ulceration 10.68 9.34 48 152195 26784 46507035
Eustachian tube disorder 10.66 9.34 5 152238 65 46533754
Left ventricular hypertrophy 10.62 9.34 38 152205 4925 46528894
Analgesic drug level increased 10.40 9.34 18 152225 1476 46532343
Peritoneal perforation 10.32 9.34 6 152237 124 46533695
Injection site swelling 10.32 9.34 83 152160 40244 46493575
Apathy 10.29 9.34 49 152194 7219 46526600
Tuberculosis 10.23 9.34 11 152232 10254 46523565
Respiratory dyskinesia 10.23 9.34 4 152239 32 46533787
Anger 10.23 9.34 70 152173 11782 46522037
Secretion discharge 10.21 9.34 9 152234 9210 46524609
Anaphylactic shock 10.19 9.34 33 152210 20241 46513578
Self-medication 10.16 9.34 22 152221 2130 46531689
Mood swings 10.14 9.34 89 152154 16163 46517656
Vertigo CNS origin 10.13 9.34 4 152239 33 46533786
Uveitis 10.11 9.34 8 152235 8633 46525186
Ill-defined disorder 10.09 9.34 49 152194 26778 46507041
Immunodeficiency 10.07 9.34 17 152226 13089 46520730
Impetigo 10.07 9.34 14 152229 949 46532870
Bronchopulmonary aspergillosis 10.02 9.34 6 152237 7490 46526329
Foetal exposure during pregnancy 9.98 9.34 59 152184 30688 46503131
Middle insomnia 9.95 9.34 59 152184 9456 46524363
Haemangioma congenital 9.94 9.34 10 152233 480 46533339
Anal incontinence 9.83 9.34 69 152174 11709 46522110
Proteinuria 9.74 9.34 25 152218 16528 46517291
Pain in extremity 9.74 9.34 719 151524 257961 46275858
Drug diversion 9.73 9.34 13 152230 848 46532971
Psoriatic arthropathy 9.71 9.34 74 152169 36305 46497514
Dysphoria 9.70 9.34 35 152208 4554 46529265
Dreamy state 9.63 9.34 4 152239 38 46533781
Trance 9.63 9.34 4 152239 38 46533781
Fatigue 9.62 9.34 1794 150449 606903 45926916
Sensitivity to weather change 9.62 9.34 3 152240 5513 46528306
Apallic syndrome 9.61 9.34 11 152232 612 46533207
Serotonin syndrome 9.60 9.34 121 152122 24099 46509720
Psychotic behaviour 9.51 9.34 11 152232 619 46533200
Multiple sclerosis 9.47 9.34 123 152120 24668 46509151
Glaucoma 9.40 9.34 24 152219 15897 46517922
Labelled drug-food interaction issue 9.40 9.34 3 152240 12 46533807
Euphoric mood 9.39 9.34 33 152210 4239 46529580
Blood creatinine increased 9.39 9.34 184 152059 76219 46457600
Pathogen resistance 9.37 9.34 4 152239 6056 46527763
Alkalosis 9.36 9.34 8 152235 311 46533508

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 747.17 10.11 1173 87472 98319 29765514
Somnambulism 619.93 10.11 263 88382 2951 29860882
Drug dependence 336.11 10.11 363 88282 20932 29842901
Intentional overdose 284.41 10.11 470 88175 41011 29822822
Drug abuse 279.70 10.11 695 87950 81377 29782456
Amnesia 272.80 10.11 348 88297 23973 29839860
Insomnia 222.56 10.11 694 87951 92642 29771191
Suicide attempt 194.99 10.11 372 88273 36325 29827508
Toxicity to various agents 173.17 10.11 1003 87642 176180 29687653
Intentional self-injury 163.45 10.11 201 88444 13331 29850502
Road traffic accident 147.04 10.11 215 88430 16856 29846977
Abnormal sleep-related event 129.66 10.11 51 88594 463 29863370
Poisoning 121.52 10.11 159 88486 11223 29852610
Sleep-related eating disorder 117.03 10.11 41 88604 259 29863574
Somnolence 111.96 10.11 574 88071 96189 29767644
Respiratory arrest 109.34 10.11 257 88388 29001 29834832
Sopor 107.33 10.11 147 88498 10844 29852989
Parasomnia 102.63 10.11 37 88608 257 29863576
Impaired driving ability 101.06 10.11 73 88572 2445 29861388
Drug withdrawal syndrome 100.51 10.11 197 88448 19612 29844221
Overdose 96.64 10.11 499 88146 83838 29779995
Abnormal behaviour 95.66 10.11 225 88420 25398 29838435
Off label use 91.11 10.11 404 88241 248886 29614947
Confusional state 87.38 10.11 690 87955 134144 29729689
Suicidal ideation 86.32 10.11 269 88376 35845 29827988
Delirium 81.34 10.11 285 88360 40346 29823487
Depression 74.85 10.11 491 88154 89946 29773887
Anxiety 73.82 10.11 487 88158 89384 29774449
Homicide 70.63 10.11 42 88603 1004 29862829
Poisoning deliberate 65.39 10.11 84 88561 5820 29858013
Bradyphrenia 61.59 10.11 67 88578 3890 29859943
Automatism 61.14 10.11 19 88626 77 29863756
Coma 59.93 10.11 258 88387 40191 29823642
Suicidal behaviour 58.14 10.11 41 88604 1321 29862512
Withdrawal syndrome 57.20 10.11 112 88533 11138 29852695
Cardio-respiratory arrest 55.46 10.11 324 88321 56982 29806851
Product use in unapproved indication 55.01 10.11 83 88562 73610 29790223
Rheumatoid arthritis 49.91 10.11 30 88615 41167 29822666
Disorientation 49.34 10.11 204 88441 31214 29832619
Gun shot wound 48.69 10.11 35 88610 1163 29862670
Drug abuser 46.22 10.11 61 88584 4340 29859493
Prescription form tampering 44.09 10.11 25 88620 545 29863288
Aggression 44.04 10.11 221 88424 36686 29827147
Drug tolerance 43.43 10.11 42 88603 2120 29861713
Anterograde amnesia 42.96 10.11 17 88628 157 29863676
Intentional product misuse 40.95 10.11 207 88438 34460 29829373
Fall 38.32 10.11 753 87892 181119 29682714
Drug ineffective 37.69 10.11 746 87899 339641 29524192
Nightmare 35.61 10.11 97 88548 11979 29851854
Initial insomnia 35.44 10.11 41 88604 2548 29861285
Sleep disorder 35.38 10.11 155 88490 24324 29839509
Memory impairment 35.19 10.11 209 88436 36965 29826868
Cytomegalovirus infection 35.18 10.11 13 88632 23661 29840172
Treatment failure 34.55 10.11 31 88614 34648 29829185
Agitation 34.54 10.11 276 88369 53797 29810036
Drug use disorder 34.08 10.11 45 88600 3203 29860630
Oedematous pancreatitis 34.05 10.11 18 88627 340 29863493
Conduction disorder 33.85 10.11 35 88610 1916 29861917
Mania 33.73 10.11 80 88565 9074 29854759
Death 33.22 10.11 805 87840 356478 29507355
Angioedema 32.77 10.11 32 88613 34352 29829481
Altered state of consciousness 32.58 10.11 131 88514 19788 29844045
Legal problem 32.52 10.11 15 88630 208 29863625
Thinking abnormal 30.88 10.11 56 88589 5255 29858578
Dependence 30.82 10.11 27 88618 1199 29862634
Antidepressant drug level above therapeutic 30.08 10.11 13 88632 153 29863680
Hallucination 29.49 10.11 247 88398 48812 29815021
Acute kidney injury 29.40 10.11 603 88042 273239 29590594
Persistent depressive disorder 29.27 10.11 15 88630 265 29863568
Joint swelling 28.59 10.11 60 88585 46886 29816947
Poor quality sleep 28.57 10.11 65 88580 7176 29856657
Irritability 28.18 10.11 139 88506 22911 29840922
Self-medication 27.57 10.11 34 88611 2260 29861573
Drug intolerance 27.49 10.11 58 88587 45233 29818600
Exposure via ingestion 27.13 10.11 36 88609 2575 29861258
Asthma 26.73 10.11 41 88604 36133 29827700
Restlessness 26.03 10.11 134 88511 22465 29841368
Analgesic drug level above therapeutic 25.25 10.11 13 88632 232 29863601
General physical health deterioration 24.99 10.11 183 88462 99761 29764072
Hypokinesia 24.15 10.11 61 88584 7199 29856634
Infection 24.11 10.11 134 88511 77940 29785893
Febrile neutropenia 24.05 10.11 201 88444 106492 29757341
Bradypnoea 23.94 10.11 29 88616 1892 29861941
Theft 23.79 10.11 13 88632 263 29863570
Multiple organ dysfunction syndrome 23.62 10.11 102 88543 63385 29800448
Paranoia 23.51 10.11 75 88570 10113 29853720
Therapeutic product effect incomplete 23.45 10.11 40 88605 33794 29830039
Sepsis 23.09 10.11 300 88345 146095 29717738
Lower respiratory tract infection 23.07 10.11 27 88618 26687 29837146
Neutropenia 22.71 10.11 257 88388 128283 29735550
Septic shock 22.58 10.11 104 88541 63503 29800330
Visceral congestion 22.35 10.11 16 88629 528 29863305
Sleep apnoea syndrome 22.30 10.11 104 88541 16753 29847080
Thermophobia 22.30 10.11 9 88636 88 29863745
Circadian rhythm sleep disorder 22.29 10.11 14 88631 370 29863463
Akathisia 22.19 10.11 52 88593 5852 29857981
Incoherent 22.16 10.11 42 88603 4076 29859757
Cardiac failure 21.70 10.11 151 88494 83267 29780566
Drug resistance 21.27 10.11 17 88628 20116 29843717
Pyrexia 21.04 10.11 688 87957 293801 29570032
Abnormal dreams 20.83 10.11 62 88583 8053 29855780
Disturbance in attention 20.67 10.11 124 88521 22005 29841828
Anger 20.53 10.11 76 88569 11044 29852789
Tachyphrenia 20.25 10.11 20 88625 1036 29862797
Erythema 20.24 10.11 140 88505 77311 29786522
Dyspnoea 19.68 10.11 797 87848 332498 29531335
Victim of chemical submission 19.62 10.11 7 88638 47 29863786
Loss of consciousness 19.22 10.11 336 88309 79039 29784794
Panic attack 19.21 10.11 63 88582 8618 29855215
Cardiac arrest 19.02 10.11 383 88262 92467 29771366
Drug withdrawal convulsions 18.70 10.11 20 88625 1139 29862694
Stress at work 18.36 10.11 9 88636 144 29863689
Acute stress disorder 18.19 10.11 9 88636 147 29863686
Hallucination, visual 18.18 10.11 95 88550 16018 29847815
Lactic acidosis 18.09 10.11 41 88604 31172 29832661
Major depression 18.02 10.11 38 88607 3984 29859849
Impatience 17.81 10.11 11 88634 282 29863551
Perseveration 17.80 10.11 8 88637 104 29863729
Transplant rejection 17.63 10.11 3 88642 9203 29854630
Mental status changes 17.38 10.11 177 88468 36902 29826931
Reduced facial expression 17.29 10.11 16 88629 764 29863069
Drug tolerance increased 17.06 10.11 12 88633 385 29863448
Synovitis 17.04 10.11 4 88641 9779 29854054
Depressed level of consciousness 16.76 10.11 180 88465 38042 29825791
Pruritus 16.57 10.11 248 88397 117956 29745877
Myocardial infarction 16.45 10.11 267 88378 125358 29738475
Asphyxia 16.42 10.11 44 88601 5381 29858452
Bradykinesia 16.23 10.11 32 88613 3198 29860635
Victim of homicide 16.21 10.11 8 88637 130 29863703
Peripheral swelling 16.15 10.11 110 88535 60964 29802869
Labelled drug-food interaction medication error 16.02 10.11 6 88639 47 29863786
Adrenocorticotropic hormone deficiency 16.00 10.11 12 88633 426 29863407
Apallic syndrome 15.87 10.11 10 88635 266 29863567
Libido decreased 15.85 10.11 39 88606 4527 29859306
Infusion related reaction 15.81 10.11 64 88581 40500 29823333
Nervousness 15.80 10.11 73 88572 11715 29852118
Renal impairment 15.78 10.11 166 88479 84018 29779815
Oral discharge 15.73 10.11 8 88637 139 29863694
Dissociative disorder 15.73 10.11 8 88637 139 29863694
Drug screen positive 15.68 10.11 38 88607 4369 29859464
Personality change 15.66 10.11 39 88606 4561 29859272
Hypogonadism 15.42 10.11 20 88625 1399 29862434
Victim of crime 15.32 10.11 10 88635 283 29863550
Skin laceration 15.32 10.11 70 88575 11181 29852652
Acute myocardial infarction 15.19 10.11 93 88552 52846 29810987
Drug diversion 15.12 10.11 16 88629 900 29862933
Sexual abuse 15.04 10.11 8 88637 153 29863680
Rectal haemorrhage 15.00 10.11 53 88592 34886 29828947
Sleep talking 14.87 10.11 12 88633 475 29863358
Alcohol interaction 14.80 10.11 28 88617 2714 29861119
Brachial plexus injury 14.51 10.11 7 88638 108 29863725
Tubulointerstitial nephritis 14.48 10.11 19 88626 17872 29845961
Product dose omission issue 14.35 10.11 188 88457 91443 29772390
Pneumothorax traumatic 14.32 10.11 6 88639 65 29863768
Hallucination, auditory 14.15 10.11 62 88583 9727 29854106
Neurotoxicity 14.09 10.11 11 88634 13171 29850662
Amimia 14.05 10.11 4 88641 11 29863822
Coagulation factor VII level decreased 13.90 10.11 7 88638 119 29863714
Intentional product use issue 13.88 10.11 58 88587 36382 29827451
Pulmonary fibrosis 13.78 10.11 16 88629 15874 29847959
Sciatic nerve neuropathy 13.63 10.11 6 88639 74 29863759
Differentiation syndrome 13.63 10.11 17 88628 1143 29862690
Galactorrhoea 13.58 10.11 10 88635 345 29863488
Miosis 13.41 10.11 52 88593 7724 29856109
Inappropriate antidiuretic hormone secretion 13.34 10.11 68 88577 11354 29852479
Dry mouth 13.17 10.11 114 88531 22736 29841097
Poor feeding infant 12.95 10.11 10 88635 371 29863462
Electrocardiogram J wave 12.91 10.11 4 88641 16 29863817
Myelosuppression 12.74 10.11 3 88642 7319 29856514
Prostate cancer stage II 12.62 10.11 8 88637 215 29863618
Imprisonment 12.59 10.11 11 88634 487 29863346
Ataxia 12.53 10.11 67 88578 11395 29852438
Slow speech 12.33 10.11 15 88630 983 29862850
Respiratory failure 12.17 10.11 217 88428 100425 29763408
Sciatic nerve injury 12.13 10.11 6 88639 98 29863735
Hospitalisation 12.13 10.11 79 88566 44240 29819593
Drowning 12.12 10.11 10 88635 409 29863424
Family stress 12.09 10.11 7 88638 159 29863674
Scar pain 12.03 10.11 5 88640 53 29863780
Congenital hydrocephalus 11.86 10.11 6 88639 103 29863730
Blood pressure fluctuation 11.85 10.11 21 88624 17482 29846351
Amnestic disorder 11.75 10.11 7 88638 168 29863665
Psychotic disorder 11.71 10.11 106 88539 21409 29842424
Leukopenia 11.67 10.11 108 88537 56051 29807782
Grandiosity 11.66 10.11 9 88636 334 29863499
Cough 11.62 10.11 283 88362 125359 29738474
Hypersensitivity 11.62 10.11 103 88542 53925 29809908
Bone marrow failure 11.60 10.11 47 88598 29738 29834095
Aspergillus infection 11.60 10.11 8 88637 10206 29853627
Condition aggravated 11.56 10.11 315 88330 137551 29726282
Mental disorder due to a general medical condition 11.53 10.11 7 88638 174 29863659
Diarrhoea 11.44 10.11 843 87802 333260 29530573
Hangover 11.41 10.11 15 88630 1063 29862770
Spigelian hernia 11.20 10.11 3 88642 6 29863827
Epstein-Barr virus infection 11.18 10.11 3 88642 6703 29857130
Myoclonic epilepsy 11.17 10.11 13 88632 813 29863020
C-reactive protein increased 11.14 10.11 79 88566 43394 29820439
Loss of personal independence in daily activities 11.13 10.11 30 88615 21505 29842328
Delusion 11.08 10.11 67 88578 11922 29851911
Renal injury 11.07 10.11 11 88634 11718 29852115
Psoriasis 11.01 10.11 77 88568 42429 29821404
Coprolalia 10.95 10.11 4 88641 29 29863804
Feeling abnormal 10.92 10.11 232 88413 56524 29807309
Logorrhoea 10.91 10.11 21 88624 2061 29861772
Hyperbilirubinaemia 10.87 10.11 21 88624 16921 29846912
Pilonidal cyst congenital 10.83 10.11 4 88641 30 29863803
Neutrophil count increased 10.72 10.11 18 88627 15305 29848528
Meningomyelocele 10.66 10.11 6 88639 129 29863704
Feeling drunk 10.62 10.11 18 88627 1601 29862232
Cholestasis 10.60 10.11 38 88607 24912 29838921
Hyperlipidaemia 10.58 10.11 74 88571 13833 29850000
Thrombocytopenia 10.51 10.11 317 88328 136727 29727106
Urticaria 10.50 10.11 107 88538 54499 29809334
Neutropenic sepsis 10.43 10.11 11 88634 11398 29852435
Anaphylactic reaction 10.38 10.11 45 88600 27937 29835896
Labile hypertension 10.37 10.11 5 88640 77 29863756
Hyperhidrosis 10.37 10.11 266 88379 66824 29797009
Drug half-life reduced 10.35 10.11 3 88642 9 29863824
Testicular retraction 10.35 10.11 3 88642 9 29863824
Staring 10.33 10.11 17 88628 1476 29862357

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
FDA PE N0000175728 Central Nervous System Depression
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist
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

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)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
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-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR EC50 6.70 WOMBAT-PK CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel ALLOSTERIC MODULATOR Ki 7.68 IUPHAR IUPHAR
GABA-A receptor alpha-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.57 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-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.16 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter Km 3.70 WOMBAT-PK
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
GABA A receptor alpha-2/beta-2/gamma-2 Ion channel Ki 6.81 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel Ki 7.30 CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel Ki 6.42 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel Ki 6.12 CHEMBL
CAAX prenyl protease 2 Unclassified AC50 4.77 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; anion channel Ion channel Ki 7.60 CHEMBL
GABA-A receptor; alpha-1/beta-2/gamma-2 Ion channel Ki 7.72 CHEMBL
Translocator protein Membrane receptor IC50 5.33 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
CHEMBL1723343 ChEMBL_ID
D000077334 MESH_DESCRIPTOR_UI
5732 PUBCHEM_CID
5741 INN_ID
7K383OQI23 UNII
4348 IUPHAR_LIGAND_ID
DB00425 DRUGBANK_ID
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 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0074 TABLET, FILM COATED 10 mg ORAL ANDA 31 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