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 For the short-term treatment of insomnia.
Marketing Status Prescription; Discontinued
ATC Code N05CF02
DrugBank ID DB00425
KEGG ID D08690
MeSH ID D000077334
PubChem ID 5732
TTD Drug ID D0T1WN
NDC Product Code Not Available
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood pressure increased13.14.03.005--Not Available
Blood urea increased13.13.01.006--Not Available
Body temperature increased13.15.01.0010.000163%Not Available
Bradycardia02.03.02.0020.001956%Not Available
Bradykinesia17.01.02.0040.000489%Not Available
Breast neoplasm21.05.01.004; 16.10.02.001--Not Available
Breast pain21.05.05.003--
Breast tenderness21.05.05.0040.000109%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Bulimia nervosa14.03.03.001; 19.09.01.0060.000217%Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Cardiac arrest02.03.04.0010.000411%
Cardiac failure congestive02.05.01.002--Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000680%Not Available
Cardiogenic shock24.06.02.006; 02.05.01.0030.000163%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cerebrovascular disorder24.03.05.002; 17.08.02.002--Not Available
Chest discomfort08.01.08.019; 02.02.02.009; 22.02.08.0010.000706%Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.0010.000543%
Cholecystitis acute09.03.01.0030.000163%Not Available
Cholecystitis chronic09.03.01.0040.000163%Not Available
Chorea17.01.01.0010.000435%Not Available
Cleft lip15.11.05.002; 07.05.08.002; 03.11.05.0020.000109%Not Available
Clonus17.02.05.0020.000217%Not Available
Coma17.02.09.0010.005486%Not Available
Compartment syndrome24.04.05.006; 15.05.05.0050.000109%Not Available
Completed suicide19.12.01.001; 08.04.01.0100.002551%Not Available
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