Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Zolpidem
Drug ID BADD_D02394
Description Zolpidem, also known as _Ambien_, is a hypnotic drug that was initially approved by the FDA in 1992 [FDA label]. Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms [FDA label], [F3802]. Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance [A175426]. In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties [L5584]. Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury [L5584], [A175444].
Indications and Usage This drug is indicated for the short-term treatment of insomnia in adults characterized by difficulties with sleep initiation [FDA label].
Marketing Status approved
ATC Code N05CF02
DrugBank ID DB00425
KEGG ID D08690
MeSH ID D000077334
PubChem ID 5732
TTD Drug ID D0T1WN
NDC Product Code Not Available
UNII 7K383OQI23
Synonyms Zolpidem | Imidazo(1,2-a)pyridine-3-acetamide, N,N,6-trimethyl-2-(4-methylphenyl)- | SL 80.0750 | SL-800750-23-N | SL 800750 23 N | Zolirin | Zolpi-Lich | Zolpi Lich | Zolpidem 1A Pharma | Zolpidem AbZ | Zolpidem Tartrate | N,N,6-Trimethyl-2-(4-methylphenyl)imidazo(1,2a)pyridine-3-acetamide hemitartrate | Zolpidem Hemitartrate | Zolpinox | Zolpimist | Ambien | Amsic | Bikalm | Stilnoct | Stilnox | Dalparan | Zodormdura | Zoldem
Chemical Information
Molecular Formula C19H21N3O
CAS Registry Number 82626-48-0
SMILES CC1=CC=C(C=C1)C2=C(N3C=C(C=CC3=N2)C)CC(=O)N(C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Respiratory depression17.02.05.047; 22.02.01.0100.000115%-
Respiratory distress22.02.01.0120.000153%-
Restlessness17.02.05.021; 19.11.02.0020.000561%
Retching07.01.07.0020.000038%-
Retrograde amnesia17.03.02.006; 19.20.01.0060.000025%-
Rhabdomyolysis15.05.05.0020.000484%
Rhinitis11.01.13.004; 22.07.03.006--
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.000076%
Saliva altered07.06.01.004---
Salivary hypersecretion07.06.01.009---
Sciatica15.10.01.001; 17.10.03.001---
Scleritis06.04.07.002; 10.02.01.025---
Screaming08.01.03.099; 19.04.02.0200.000056%-
Sedation17.02.04.0050.000395%-
Seizure17.12.03.0010.000879%
Serotonin syndrome12.03.01.041; 15.05.04.016; 17.05.02.0040.000089%-
Shock24.06.02.002---
Sinus tachycardia02.03.03.0100.000115%
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007---
Skin odour abnormal23.03.03.0120.000025%
Skin wrinkling23.01.03.001---
Sleep disorder19.02.04.0010.000726%-
Sleep talking17.15.02.003; 19.02.03.0050.000025%-
Sleep terror17.15.02.006; 19.02.03.0080.000087%-
Sluggishness08.01.01.0040.000089%-
Sneezing22.12.03.0240.000038%
Somnambulism17.15.02.004; 19.02.03.0060.002732%-
Somnolence17.02.04.006; 19.02.05.0030.002803%
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.0270.000324%-
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