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 6348.28 45.82 1480 5373 19554 2331678
Toxicity to various agents 4111.95 45.82 1151 5702 31603 2319629
Drug abuse 2024.98 45.82 538 6315 11488 2339744
Intentional overdose 1376.21 45.82 393 6460 10928 2340304
Somnambulism 1360.20 45.82 245 6608 645 2350587
Amnesia 1266.42 45.82 335 6518 6918 2344314
Overdose 1137.90 45.82 388 6465 19519 2331713
Drug dependence 1054.33 45.82 244 6609 2801 2348431
Suicide attempt 986.50 45.82 304 6549 10978 2340254
Coma 968.11 45.82 285 6568 8771 2342461
Cardio-respiratory arrest 952.16 45.82 282 6571 8864 2342368
Somnolence 778.88 45.82 307 6546 23178 2328054
Cardiac arrest 769.73 45.82 270 6583 14660 2336572
Respiratory arrest 759.60 45.82 217 6636 5961 2345271
Fall 696.13 45.82 349 6504 46750 2304482
Confusional state 692.16 45.82 285 6568 24059 2327173
Intentional product misuse 619.20 45.82 205 6648 9284 2341948
Sopor 584.82 45.82 161 6692 3834 2347398
Poisoning 566.44 45.82 146 6707 2674 2348558
Insomnia 551.46 45.82 247 6606 25540 2325692
Loss of consciousness 496.39 45.82 209 6644 18558 2332674
Drug ineffective 459.58 45.82 354 6499 101270 2249962
Abnormal sleep-related event 457.70 45.82 75 6778 80 2351152
Road traffic accident 447.80 45.82 133 6720 4175 2347057
Hypotension 421.38 45.82 221 6632 32215 2319017
Intentional self-injury 418.43 45.82 125 6728 4002 2347230
Drug hypersensitivity 374.40 45.82 232 6621 46411 2304821
Abnormal behaviour 359.26 45.82 115 6738 4645 2346587
Sleep-related eating disorder 344.06 45.82 58 6795 84 2351148
Hallucination 288.08 45.82 112 6741 8036 2343196
Delirium 281.72 45.82 98 6755 5125 2346107
Tachycardia 274.69 45.82 133 6720 16276 2334956
Impaired driving ability 267.83 45.82 66 6787 993 2350239
Exposure via ingestion 265.95 45.82 62 6791 726 2350506
Agitation 264.87 45.82 115 6738 10936 2340296
Drug interaction 261.49 45.82 156 6697 29007 2322225
Drug withdrawal syndrome 259.79 45.82 99 6754 6722 2344510
Product substitution issue 257.62 45.82 91 6762 4978 2346254
Bradycardia 249.45 45.82 107 6746 9874 2341358
Disorientation 244.51 45.82 93 6760 6279 2344953
Withdrawal syndrome 236.86 45.82 77 6776 3260 2347972
Poisoning deliberate 230.78 45.82 60 6793 1131 2350101
Anxiety 222.19 45.82 141 6712 29218 2322014
Hallucination, visual 220.63 45.82 71 6782 2908 2348324
Mydriasis 210.87 45.82 64 6789 2155 2349077
Suicidal ideation 210.27 45.82 98 6755 10989 2340243
Unresponsive to stimuli 190.01 45.82 72 6781 4804 2346428
Accidental overdose 189.24 45.82 68 6785 3904 2347328
Death 180.92 45.82 191 6662 81277 2269955
Aggression 176.88 45.82 68 6785 4718 2346514
Depressed level of consciousness 168.68 45.82 75 6778 7529 2343703
Miosis 168.09 45.82 47 6806 1177 2350055
Vomiting 162.63 45.82 170 6683 71432 2279800
Electrocardiogram QT prolonged 154.08 45.82 71 6782 7743 2343489
Altered state of consciousness 153.99 45.82 58 6795 3802 2347430
Sleep talking 151.73 45.82 30 6823 146 2351086
Tremor 148.10 45.82 96 6757 20565 2330667
Dysarthria 145.68 45.82 64 6789 6238 2344994
Pneumonia aspiration 141.23 45.82 54 6799 3688 2347544
Disturbance in attention 135.51 45.82 59 6794 5626 2345606
Restlessness 134.25 45.82 55 6798 4508 2346724
Myocardial depression 131.05 45.82 23 6830 48 2351184
Mental status changes 130.02 45.82 57 6796 5525 2345707
Respiratory depression 129.66 45.82 44 6809 2126 2349106
Decorticate posture 126.85 45.82 21 6832 25 2351207
Depression 125.76 45.82 98 6755 28034 2323198
Memory impairment 125.67 45.82 73 6780 12850 2338382
Bradypnoea 124.75 45.82 30 6823 404 2350828
Ventricular hypokinesia 123.69 45.82 32 6821 590 2350642
Generalised tonic-clonic seizure 122.35 45.82 54 6799 5318 2345914
Coma scale abnormal 119.60 45.82 33 6820 785 2350447
Sleep disorder 118.72 45.82 56 6797 6433 2344799
Seizure 117.59 45.82 89 6764 24377 2326855
Prescription form tampering 113.43 45.82 23 6830 130 2351102
Hypothermia 106.89 45.82 38 6815 2110 2349122
Contusion 105.41 45.82 65 6788 12745 2338487
Sedation 103.93 45.82 42 6811 3320 2347912
Speech disorder 100.77 45.82 50 6803 6414 2344818
Victim of sexual abuse 92.18 45.82 18 6835 81 2351151
Dizziness 88.51 45.82 113 6740 58552 2292680
Drug tolerance 85.46 45.82 22 6831 397 2350835
Therapeutic response unexpected 85.31 45.82 38 6815 3821 2347411
Balance disorder 84.11 45.82 51 6802 9696 2341536
Depressed mood 83.37 45.82 41 6812 5157 2346075
Chemical submission 81.94 45.82 14 6839 23 2351209
Rhabdomyolysis 81.84 45.82 44 6809 6660 2344572
Feeling abnormal 79.90 45.82 70 6783 23511 2327721
Psychomotor retardation 78.26 45.82 22 6831 561 2350671
Acute respiratory distress syndrome 77.88 45.82 34 6819 3258 2347974
Metabolic acidosis 77.82 45.82 41 6812 5957 2345275
Nightmare 77.25 45.82 35 6818 3662 2347570
Homicide 76.59 45.82 16 6837 107 2351125
Bradyphrenia 76.46 45.82 25 6828 1074 2350158
Parasomnia 76.19 45.82 15 6838 71 2351161
Alcohol abuse 76.01 45.82 19 6834 303 2350929
Exposure during pregnancy 75.85 45.82 70 6783 25149 2326083
Irritability 75.15 45.82 41 6812 6386 2344846
Substance abuse 74.98 45.82 21 6832 528 2350704
Victim of chemical submission 74.72 45.82 14 6839 48 2351184
Eating disorder 72.23 45.82 29 6824 2252 2348980
Hepatic necrosis 72.20 45.82 24 6829 1086 2350146
Drug abuser 71.49 45.82 23 6830 938 2350294
Drop attacks 71.25 45.82 16 6837 156 2351076
Anterograde amnesia 70.84 45.82 15 6838 108 2351124
Condition aggravated 70.62 45.82 75 6778 31904 2319328
Cognitive disorder 70.42 45.82 37 6816 5344 2345888
Hallucination, auditory 66.42 45.82 27 6826 2165 2349067
Haematoma 66.41 45.82 35 6818 5086 2346146
Cardiogenic shock 66.40 45.82 28 6825 2463 2348769
Dyskinesia 65.73 45.82 34 6819 4755 2346477
Maternal exposure during pregnancy 64.63 45.82 51 6802 14812 2336420
Drug withdrawal convulsions 64.53 45.82 17 6836 337 2350895
Nausea 63.51 45.82 139 6714 112050 2239182
Drug-induced liver injury 61.77 45.82 30 6823 3669 2347563
Hypersensitivity vasculitis 60.87 45.82 22 6831 1280 2349952
Psychotic disorder 60.73 45.82 32 6821 4647 2346585
Hyperreflexia 60.68 45.82 20 6833 881 2350351
Electrocardiogram QRS complex prolonged 60.57 45.82 21 6832 1081 2350151
Mania 60.32 45.82 26 6827 2414 2348818
Drug screen positive 60.27 45.82 20 6833 900 2350332
Incorrect dose administered 59.60 45.82 41 6812 9654 2341578
Encephalopathy 58.65 45.82 31 6822 4530 2346702
Middle insomnia 58.17 45.82 22 6831 1455 2349777
Parkinsonism hyperpyrexia syndrome 56.93 45.82 10 6843 21 2351211
Head injury 56.40 45.82 29 6824 4005 2347227
Fatigue 55.95 45.82 112 6741 84761 2266471
Headache 55.49 45.82 108 6745 80071 2271161
Hypertension 54.84 45.82 61 6792 27300 2323932
Drug use disorder 54.54 45.82 15 6838 352 2350880
Hyponatraemia 54.25 45.82 44 6809 13281 2337951
Crying 54.05 45.82 29 6824 4367 2346865
Catatonia 53.78 45.82 18 6835 832 2350400
Syncope 52.96 45.82 48 6805 16827 2334405
Pulmonary congestion 52.08 45.82 22 6831 1943 2349289
Pancreatitis acute 51.85 45.82 27 6826 3826 2347406
Gait disturbance 51.73 45.82 54 6799 22491 2328741
Hypokalaemia 51.63 45.82 39 6814 10615 2340617
Vertigo 51.44 45.82 37 6816 9347 2341885
Cardiomegaly 51.05 45.82 23 6830 2373 2348859
Asthenia 50.60 45.82 77 6776 46849 2304383
Hangover 50.58 45.82 13 6840 233 2350999
Impaired work ability 50.44 45.82 21 6832 1789 2349443
Spleen congestion 50.34 45.82 10 6843 50 2351182
Weight increased 48.58 45.82 52 6801 22285 2328947
Acute kidney injury 48.46 45.82 58 6795 28064 2323168
Analgesic drug level increased 48.37 45.82 13 6840 279 2350953
Mental disorder 48.05 45.82 26 6827 3981 2347251
Leukocytosis 47.95 45.82 25 6828 3551 2347681
Product complaint 47.71 45.82 27 6826 4511 2346721
Hypokinesia 47.70 45.82 20 6833 1734 2349498
Hyperthermia 47.64 45.82 19 6834 1449 2349783
Blepharospasm 47.51 45.82 15 6838 575 2350657
Respiratory distress 47.24 45.82 28 6825 5101 2346131
Blood creatine phosphokinase increased 47.20 45.82 28 6825 5108 2346124
Asphyxia 47.07 45.82 17 6836 987 2350245
Aspiration 46.83 45.82 19 6834 1515 2349717
Acute pulmonary oedema 46.81 45.82 18 6835 1245 2349987
Oxygen saturation decreased 46.43 45.82 32 6821 7554 2343678
Logorrhoea 45.98 45.82 14 6839 475 2350757
Affective disorder 45.92 45.82 16 6837 836 2350396

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 3320.76 48.95 856 3734 15456 1726735
Toxicity to various agents 2090.91 48.95 683 3907 28458 1713733
Drug abuse 1471.67 48.95 440 4150 13249 1728942
Somnambulism 1211.94 48.95 218 4372 496 1741695
Amnesia 969.69 48.95 255 4335 4636 1737555
Intentional overdose 803.95 48.95 243 4347 7427 1734764
Drug dependence 753.04 48.95 193 4397 3134 1739057
Respiratory arrest 623.85 48.95 188 4402 5651 1736540
Confusional state 615.08 48.95 259 4331 21019 1721172
Cardio-respiratory arrest 592.54 48.95 202 4388 9091 1733100
Overdose 590.46 48.95 235 4355 16466 1725725
Somnolence 586.44 48.95 234 4356 16505 1725686
Suicide attempt 556.00 48.95 182 4408 7199 1734992
Cardiac arrest 513.82 48.95 210 4380 15720 1726471
Poisoning 490.58 48.95 130 4460 2402 1739789
Road traffic accident 480.47 48.95 138 4452 3475 1738716
Fall 409.05 48.95 211 4379 27003 1715188
Abnormal behaviour 404.00 48.95 138 4452 6204 1735987
Delirium 391.85 48.95 135 4455 6227 1735964
Intentional self-injury 377.14 48.95 107 4483 2566 1739625
Coma 374.37 48.95 135 4455 7127 1735064
Sopor 336.74 48.95 92 4498 1909 1740282
Insomnia 311.42 48.95 149 4441 16127 1726064
Impaired driving ability 290.51 48.95 64 4526 509 1741682
Hallucination 284.06 48.95 114 4476 8056 1734135
Intentional product misuse 267.32 48.95 106 4484 7252 1734939
Agitation 257.49 48.95 116 4474 10910 1731281
Abnormal sleep-related event 227.83 48.95 41 4549 91 1742100
Depressed level of consciousness 215.27 48.95 88 4502 6504 1735687
Drug interaction 213.48 48.95 140 4450 27818 1714373
Disorientation 213.31 48.95 83 4507 5386 1736805
Poisoning deliberate 205.32 48.95 52 4538 790 1741401
Sleep-related eating disorder 202.72 48.95 35 4555 54 1742137
Aggression 194.43 48.95 87 4503 8028 1734163
Drug ineffective 183.80 48.95 180 4410 63621 1678570
Altered state of consciousness 172.30 48.95 63 4527 3434 1738757
Anxiety 167.31 48.95 97 4493 15430 1726761
Withdrawal syndrome 165.90 48.95 55 4535 2233 1739958
Loss of consciousness 165.79 48.95 95 4495 14780 1727411
Tachycardia 160.69 48.95 88 4502 12540 1729651
Drug withdrawal syndrome 153.06 48.95 62 4528 4463 1737728
Mental status changes 135.48 48.95 62 4528 6013 1736178
Conduction disorder 129.48 48.95 31 4559 367 1741824
Hallucination, visual 128.76 48.95 47 4543 2545 1739646
Nightmare 121.80 48.95 46 4544 2741 1739450
Hypotension 114.75 48.95 99 4491 29555 1712636
Suicidal ideation 112.79 48.95 61 4529 8457 1733734
Parasomnia 108.87 48.95 21 4569 77 1742114
Exposure via ingestion 108.38 48.95 30 4560 650 1741541
Drug hypersensitivity 108.37 48.95 73 4517 15062 1727129
Irritability 106.43 48.95 51 4539 5481 1736710
Vomiting 105.86 48.95 106 4484 38209 1703982
Depression 101.99 48.95 73 4517 16596 1725595
Drug use disorder 100.08 48.95 26 4564 438 1741753
Death 99.96 48.95 155 4435 87288 1654903
Medication error 98.20 48.95 46 4544 4697 1737494
Ataxia 96.19 48.95 37 4553 2316 1739875
Restlessness 95.97 48.95 44 4546 4277 1737914
Automatism 92.03 48.95 17 4573 46 1742145
Suicidal behaviour 90.83 48.95 23 4567 348 1741843
Psychotic disorder 89.38 48.95 44 4546 5012 1737179
Miosis 89.29 48.95 31 4559 1447 1740744
Paranoia 84.54 48.95 33 4557 2148 1740043
Prescription form tampering 81.97 48.95 18 4572 140 1742051
Sleep disorder 79.78 48.95 38 4552 4025 1738166
Memory impairment 77.95 48.95 44 4546 6619 1735572
Dysarthria 76.15 48.95 40 4550 5219 1736972
Unresponsive to stimuli 75.07 48.95 38 4552 4591 1737600
Asphyxia 74.34 48.95 25 4565 1058 1741133
Incoherent 72.40 48.95 23 4567 811 1741380
Lethargy 69.64 48.95 42 4548 7142 1735049
Bradyphrenia 68.94 48.95 21 4569 643 1741548
Blood creatine phosphokinase increased 68.83 48.95 45 4545 8811 1733380
Homicide 68.68 48.95 18 4572 314 1741877
Product substitution issue 68.39 48.95 32 4558 3254 1738937
Anterograde amnesia 68.09 48.95 14 4576 76 1742115
Sedation 67.20 48.95 32 4558 3385 1738806
Accidental overdose 66.98 48.95 34 4556 4130 1738061
Skin laceration 66.69 48.95 27 4563 1934 1740257
Delusion 66.65 48.95 28 4562 2203 1739988
Rhabdomyolysis 66.45 48.95 48 4542 11042 1731149
Disturbance in attention 66.45 48.95 34 4556 4200 1737991
Electrocardiogram QT prolonged 65.88 48.95 37 4553 5508 1736683
Product administration error 65.33 48.95 30 4560 2923 1739268
Incorrect dose administered 63.38 48.95 40 4550 7369 1734822
Seizure 62.71 48.95 60 4530 20381 1721810
Initial insomnia 62.26 48.95 18 4572 458 1741733
Accidental exposure to product 61.66 48.95 32 4558 4069 1738122
Gun shot wound 61.45 48.95 17 4573 367 1741824
Metabolic acidosis 61.35 48.95 35 4555 5367 1736824
Drug tolerance 61.27 48.95 17 4573 371 1741820
Bradykinesia 60.82 48.95 18 4572 498 1741693
Abnormal dreams 60.76 48.95 25 4565 1866 1740325
Thinking abnormal 58.54 48.95 22 4568 1290 1740901
Mydriasis 58.34 48.95 22 4568 1302 1740889
Mania 57.86 48.95 25 4565 2108 1740083
Pneumonia aspiration 56.81 48.95 33 4557 5233 1736958
Balance disorder 56.37 48.95 34 4556 5778 1736413
Hypoglycaemia 56.27 48.95 39 4551 8399 1733792
Self-medication 55.88 48.95 18 4572 664 1741527
Head injury 55.46 48.95 27 4563 2997 1739194
Theft 53.00 48.95 11 4579 63 1742128
Tremor 52.98 48.95 45 4545 13086 1729105
Apnoea 52.90 48.95 21 4569 1428 1740763
Alcohol use 51.97 48.95 18 4572 833 1741358
Legal problem 51.74 48.95 11 4579 72 1742119
Drug withdrawal syndrome neonatal 51.67 48.95 17 4573 671 1741520
Encephalopathy 50.96 48.95 29 4561 4423 1737768
Personality change 50.66 48.95 19 4571 1107 1741084
Dependence 50.31 48.95 14 4576 309 1741882
Hyponatraemia 49.48 48.95 37 4553 8963 1733228
Hypokinesia 49.38 48.95 19 4571 1188 1741003

Pharmacologic Action:

SourceCodeDescription
ATC N05CF02 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine related drugs
CHEBI has role CHEBI:35488 central nervous system depressant
CHEBI has role CHEBI:51373 GABA agonist
CHEBI has role CHEBI:35717 sedative
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
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist
FDA MoA N0000000196 GABA A Agonists
FDA CS M0018233 Pyridines
FDA PE N0000175728 Central Nervous System Depression

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Initial insomnia indication 59050008
Insomnia indication 193462001
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
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
D000077334 MESH_DESCRIPTOR_UI
C0487782 UMLSCUI
D00706 KEGG_DRUG
7K383OQI23 UNII
5741 INN_ID
96231005 SNOMEDCT_US
4023596 VANDF
d00910 MMSL
39993 RXNORM
387569009 SNOMEDCT_US
004146 NDDF
CHEMBL911 ChEMBL_ID
DB00425 DRUGBANK_ID
CHEBI:10125 CHEBI
99294-93-6 SECONDARY_CAS_RN
5732 PUBCHEM_CID
CHEMBL1723343 ChEMBL_ID
CHEMBL3989820 ChEMBL_ID
4348 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5401 TABLET, FILM COATED 5 mg ORAL NDA 20 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5421 TABLET, FILM COATED 10 mg ORAL NDA 20 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5501 TABLET, COATED 6.25 mg ORAL NDA 20 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5521 TABLET, COATED 12.50 mg ORAL NDA 20 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6010 TABLET 10 mg ORAL NDA 20 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6050 TABLET 5 mg ORAL NDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0086 TABLET, FILM COATED 5 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0087 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0073 TABLET, FILM COATED 5 mg ORAL ANDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0074 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Zolpidem HUMAN PRESCRIPTION DRUG LABEL 1 0143-9962 TABLET 5 mg ORAL ANDA 19 sections
Zolpidem HUMAN PRESCRIPTION DRUG LABEL 1 0143-9963 TABLET 10 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3481 TABLET, FILM COATED, EXTENDED RELEASE 6.25 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0228-3482 TABLET, FILM COATED, EXTENDED RELEASE 12.50 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8046 TABLET, FILM COATED 5 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8047 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8225 TABLET, FILM COATED 5 mg ORAL ANDA 19 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8226 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5315 TABLET, EXTENDED RELEASE 6.25 mg ORAL ANDA 20 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5316 TABLET, EXTENDED RELEASE 12.50 mg ORAL ANDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5317 TABLET, COATED 5 mg ORAL ANDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5318 TABLET, COATED 10 mg ORAL ANDA 20 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6082 TABLET 5 mg ORAL ANDA 20 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6083 TABLET 10 mg ORAL ANDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0955-1702 TABLET, FILM COATED, EXTENDED RELEASE 6.25 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0955-1703 TABLET, FILM COATED, EXTENDED RELEASE 12.50 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10370-116 TABLET, FILM COATED, EXTENDED RELEASE 12.50 mg ORAL ANDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10370-117 TABLET, FILM COATED, EXTENDED RELEASE 6.25 mg ORAL ANDA 20 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 10544-040 TABLET 10 mg ORAL ANDA 20 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-539 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections