> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/zolpidem-fe7dec7d-bbfe-4cda-b091-c32328caa7c6 > Record changed: 2026-11-04 # Zolpidem Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) First approval year 1992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) ## Development status **First approval year** 1992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **Drug name** Zolpidem Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **Molecular weight** 307.4 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **Structure (SMILES)** Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) ### Other names (18) - n n 6 trimethyl 2 p tolyl imidazo 1 2 a pyridine 3 acetamide - N,N,6-TRIMETHYL-2-P-TOLYL-IMIDAZO(1,2-A)PYRIDINE-3-ACETAMIDE - sanval - Sanval - zolpidem - Zolpidem - zolpidem \[INN\] - ZOLPIDEM \[MI\] - ZOLPIDEM \[VANDF\] - Zolpidem \[WHO-DD\] - zolpidem civ - Zolpidem civ - ZOLPIDEM CIV \[USP-RS\] - zolpidem civ usp rs - zolpidem inn - zolpidem mi - zolpidem vandf - zolpidem who dd ## Identifiers **ATC classification codes** - N05CF02 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **CAS registry numbers** - 82626-48-0 **ChEMBL ID** CHEMBL911 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **InChIKey** ZAFYATHCZYHLPB-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL911) **PubChem compound IDs** - 5732 **RxNorm IDs (RxCUI)** - 39993 **FDA ingredient codes (UNII)** - 7K383OQI23 ## Regulatory information ### United States **Applicant** COSETTE **Approval date** 16 Dec 1992 **Application number** NDA019908 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only **Boxed warning** Yes ## Approval status **United States (FDA)** Approved ## Pharmacology ### Drug classification **Pharmacology name** zolpidem **Type** Synthetic organic **Drug name stem** \-pidem **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - topical ### Mechanisms of action (3) - **Action** Positive **Action type** POSITIVE **Target** GABAA receptor α1 subunit **Gene symbol** GABRA1 **Protein identifier** P14867 **Affinity units** pKi **Primary target** Yes - **Action** Positive **Action type** POSITIVE **Target** GABAA receptor α3 subunit **Gene symbol** GABRA3 **Protein identifier** P34903 **Median affinity** 5.67 **Affinity units** pKi - **Action** Positive **Action type** POSITIVE **Target** GABAA receptor α2 subunit **Gene symbol** GABRA2 **Protein identifier** P47869 **Median affinity** 6.12 **Affinity units** pKi ### Open Targets mechanisms - **Mechanism** GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator **Action type** POSITIVE ALLOSTERIC MODULATOR **Target** GABA A receptor alpha-1/beta-1/gamma-2 ### DrugCentral mechanisms (6) - **Action type** ALLOSTERIC MODULATOR **Gene symbol** GABRA1 **Protein identifier** P14867 **Organism** Homo sapiens **Target development level** Clinical - **Action type** POSITIVE ALLOSTERIC MODULATOR **Gene symbol** GABRA1|GABRG2|GABRB3 **Protein identifier** P14867|P18507|P28472 **Organism** Homo sapiens **Target development level** Clinical - **Action type** POSITIVE ALLOSTERIC MODULATOR **Gene symbol** GABRA1|GABRG2|GABRB2 **Protein identifier** P14867|P18507|P47870 **Organism** Homo sapiens **Target development level** Clinical - **Action type** POSITIVE ALLOSTERIC MODULATOR **Gene symbol** GABRG2|GABRB3|GABRA3 **Protein identifier** P18507|P28472|P34903 **Organism** Homo sapiens **Target development level** Clinical - **Action type** POSITIVE ALLOSTERIC MODULATOR **Gene symbol** GABRG2|GABRB3|GABRA2 **Protein identifier** P18507|P28472|P47869 **Organism** Homo sapiens **Target development level** Clinical - **Action type** POSITIVE ALLOSTERIC MODULATOR **Gene symbol** GABRG2|GABRA3|GABRB2 **Protein identifier** P18507|P34903|P47870 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (15) - **Condition** Prostatic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000673 **Subject identifier** D011471 - **Condition** Obesity **Highest recorded phase** 1 **Condition identifier** EFO:0001073 **Subject identifier** D009765 - **Condition** Autistic Disorder **Highest recorded phase** 2 **Condition identifier** EFO:0003758 **Subject identifier** D001321 - **Condition** Attention Deficit Disorder with Hyperactivity **Highest recorded phase** 3 **Condition identifier** EFO:0003888 **Subject identifier** D001289 - **Condition** Substance-Related Disorders **Highest recorded phase** 2 **Condition identifier** EFO:0003890 **Subject identifier** D019966 - **Condition** Sleep Initiation and Maintenance Disorders **Highest recorded phase** 3 **Condition identifier** EFO:0004698 **Subject identifier** D007319 - **Condition** Anxiety **Highest recorded phase** 3 **Condition identifier** EFO:0005230 **Subject identifier** D001007 - **Condition** Marijuana Abuse **Highest recorded phase** 1 **Condition identifier** EFO:0007191 **Subject identifier** D002189 - **Condition** Sleep Wake Disorders **Highest recorded phase** 3 **Condition identifier** EFO:0008568 **Subject identifier** D012893 - **Condition** Dementia **Highest recorded phase** 3 **Condition identifier** HP:0000726 **Subject identifier** D003704 - **Condition** Low Back Pain **Highest recorded phase** 1 **Condition identifier** HP:0003419 **Subject identifier** D017116 - **Condition** Dystonic Disorders **Highest recorded phase** 1 **Condition identifier** MONDO:0000477 **Subject identifier** D020821 - **Condition** Depressive Disorder **Highest recorded phase** 3 **Condition identifier** MONDO:0002050 **Subject identifier** D003866 - **Condition** Schizophrenia **Highest recorded phase** 3 **Condition identifier** MONDO:0005090 **Subject identifier** D012559 - **Condition** Parkinson Disease **Highest recorded phase** 2 **Condition identifier** MONDO:0005180 **Subject identifier** D010300 ### Open Targets indications (27) - **Condition identifier** EFO\_0000246 - **Condition identifier** EFO\_0000673 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003888 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003890 - **Condition identifier** EFO\_0004698 - **Condition identifier** EFO\_0007191 **Highest recorded phase** 1 - **Condition identifier** EFO\_0008568 **Highest recorded phase** 3 - **Condition identifier** EFO\_0022597 - **Condition identifier** GO\_0030431 - **Condition identifier** HP\_0001394 - **Condition identifier** HP\_0002360 **Highest recorded phase** 2 - **Condition identifier** HP\_0002527 - **Condition identifier** HP\_0003419 - **Condition identifier** HP\_0003419 **Highest recorded phase** 1 - **Condition identifier** HP\_0030834 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0000477 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0001942 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002009 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002050 - **Condition identifier** MONDO\_0004648 - **Condition identifier** MONDO\_0004975 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004985 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005180 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005258 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005383 **Highest recorded phase** 3 And 2 more, listed on the interactive page. ### Open Targets warnings (3) - **Warning** Black Box Warning **Country** United States - **Warning** Black Box Warning **Effect** misuse **Country** United States - **Warning** Black Box Warning **Effect** vascular toxicity **Country** United States ### Reported adverse events (59) - **Event** abnormal behaviour **Reports** 166 **Reporting signal score** 221.643 - **Event** abnormal sleep-related event **Reports** 53 **Reporting signal score** 195.835 - **Event** aggression **Reports** 173 **Reporting signal score** 201.678 - **Event** agitation **Reports** 233 **Reporting signal score** 231.897 - **Event** altered state of consciousness **Reports** 151 **Reporting signal score** 237.594 - **Event** amnesia **Reports** 339 **Reporting signal score** 605.556 - **Event** anterograde amnesia **Reports** 33 **Reporting signal score** 110.089 - **Event** anxiety **Reports** 239 **Reporting signal score** 99.8729 - **Event** arthralgia **Reports** 17 **Reporting signal score** 96.6896 - **Event** automatism **Reports** 30 **Reporting signal score** 122.057 - **Event** bradyphrenia **Reports** 75 **Reporting signal score** 153.997 - **Event** bradypnoea **Reports** 65 **Reporting signal score** 175.914 - **Event** coma **Reports** 518 **Reporting signal score** 1,117.52 - **Event** coma scale abnormal **Reports** 56 **Reporting signal score** 122.823 - **Event** confusional state **Reports** 547 **Reporting signal score** 657.251 - **Event** decorticate posture **Reports** 21 **Reporting signal score** 92.7845 - **Event** delirium **Reports** 260 **Reporting signal score** 420.024 - **Event** depressed level of consciousness **Reports** 186 **Reporting signal score** 225.02 - **Event** diarrhoea **Reports** 72 **Reporting signal score** 98.6941 - **Event** disorientation **Reports** 173 **Reporting signal score** 222.536 - **Event** drug abuse **Reports** 907 **Reporting signal score** 2,243.75 - **Event** drug dependence **Reports** 538 **Reporting signal score** 1,449.44 - **Event** drug interaction **Reports** 291 **Reporting signal score** 119.192 - **Event** drug tolerance **Reports** 48 **Reporting signal score** 118.54 - **Event** drug use disorder **Reports** 87 **Reporting signal score** 222.482 And 34 more, listed on the interactive page. ### Trial references (35) - NCT00283946 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00283946) - NCT00374777 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00374777) - NCT00425243 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00425243) - NCT00440323 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00440323) - NCT00630175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00630175) - NCT00999219 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00999219) - NCT00318448 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00318448) - NCT00494468 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00494468) - NCT00608985 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00608985) - NCT00784875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00784875) - NCT00940550 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00940550) - NCT01463098 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01463098) - NCT01779830 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01779830) - NCT01804036 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01804036) - NCT02139098 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02139098) - NCT02839200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02839200) - NCT03056053 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03056053) - NCT03158025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03158025) - NCT03160404 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03160404) - NCT03375203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03375203) - NCT03885141 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03885141) - NCT05615727 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05615727) - NCT05764798 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05764798) - NCT00893269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00893269) - NCT00976105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00976105) And 10 more, listed on the interactive page. ## Dosing **Dose** 5-10mg **Route** Oral **How often** Once daily ### Conditions of use (5) - Avoid use in severe hepatic impairment - Do not readminister during the same night - Effect slowed if taken with or immediately after a meal - May need dose adjustment when combined with other CNS depressants - Take only once per night ## Chemical properties **Hydrogen bond acceptors** 3 **Hydrogen bond donors** 0 **Polar surface area** 37.61 **Calculated partition coefficient (ALogP)** 3.25 **Calculated partition coefficient (XLogP)** 2.5 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 3 **Heavy atoms** 23 **Molecular formula** C19H21N3O **Monoisotopic mass** 307.168462302 **Natural product** Yes ## Evidence counts **Recorded assays** 1,940 **Active assays** 377 ### Active assay types (4) - Confirmatory - Other - Screening - Summary ## Pharmacologic actions - Sleep Aids, Pharmaceutical Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000068776.html) - GABA-A Receptor Agonists Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D058785.html) ## Biological measurements ### Observed measurements #### Distribution coefficient (LogD) **Median** 2.325 **Mean** 2.325 **Minimum** 2.3 **Maximum** 2.35 **Unit** unitless **Assays** 2 **Standard deviation** 0.0353553 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - LogD #### Cardiac potassium channel inhibition **Median** 37,153.5 **Mean** 37,153.5 **Minimum** 37,153.5 **Maximum** 37,153.5 **Unit** nM **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - IC50 #### Solubility **Median** 260,000 **Mean** 260,000 **Minimum** 260,000 **Maximum** 260,000 **Unit** nM **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - Solubility #### Oral bioavailability **Median** 72 **Mean** 72 **Minimum** 72 **Maximum** 72 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F ## Related records ### Trials (108) - A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 - A Comparison of Midazolam and Zolpidem as Oral Premedication in Children - A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study - A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients - A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia - A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia - A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia - A Study of LY2624803 in Participants With Transient Insomnia - A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients - [A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem](https://trialight.com/data/trial/a-study-to-determine-the-abuse-potential-of-seltorexant-e761fd79-a9f0-4b7f-bd15-8ec485ba8d28.md) - A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users - A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients - A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder - Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia - Alternative Dosing Regimens in the Pharmacotherapy of Insomnia - An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia - Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers - Behavioral and Pharmacological Treatment for Insomnia - Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions - Bioequivalence Study of Zolpidem 10mg Tablets Under Fasting Conditions ### In development for (20) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 3 - Anxiety Phase 3 - Attention deficit-hyperactivity disorder Phase 3 - Autism Phase 2 - Autism spectrum disorder Phase 2 - [Bipolar disorder](https://trialight.com/data/condition/bipolar-disorder-a61ecd6f-6fb9-5323-bc0d-ebf861411d3c.md) Phase 3 - Cannabis dependence Phase 1 - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) Phase 3 - [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 3 - Drug dependence Phase 2 - Focal dystonia Phase 1 - [Generalized anxiety disorder](https://trialight.com/data/condition/generalized-anxiety-disorder-06f2f230-65ba-5929-af6a-36d14f38281d.md) Phase 3 - [Insomnia](https://trialight.com/data/condition/insomnia-57f6af86-fd71-567b-813f-5867cfd4790c.md) Phase 3 - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Phase 1 - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Phase 1 - Panic disorder Phase 3 - [Parkinson disease](https://trialight.com/data/condition/parkinson-disease-a117728d-ad75-551b-9b20-fffa9a2305ac.md) Phase 2 - Prostate adenocarcinoma Phase 1 - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Phase 3 - Sleep disorder Phase 3 ### Other linked conditions (1) - Vascular dementia ### Targets (7) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator --- ## A note for AI agents You are probably reading this for a person. 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