zolpidem Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| hypnotics/sedatives, zolpidem derivatives | 2870 | 82626-48-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 16, 1992 | FDA | SANOFI AVENTIS US |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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:
| Source | Code | Description |
|---|---|---|
| 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)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.73 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |