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)
Infection11.01.08.002--Not Available
Influenza11.05.03.001; 22.07.02.001--Not Available
Influenza like illness08.01.03.010--
Initial insomnia19.02.01.005; 17.15.03.0050.000163%Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.0020.004726%
Intentional self-injury19.12.01.002; 12.01.08.0360.006464%Not Available
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Intestinal obstruction07.13.01.002--Not Available
Intracranial pressure increased17.07.02.0020.000380%Not Available
Irritability19.04.02.013; 08.01.03.0110.000978%
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Joint stiffness15.01.02.0030.000109%Not Available
Joint swelling15.01.02.004--Not Available
Labyrinthitis11.01.05.002; 04.04.03.001--Not Available
Laceration23.03.11.004; 12.01.06.0060.000217%Not Available
Lacrimation disorder06.08.02.010--Not Available
Laryngitis22.07.03.001; 11.01.13.001--
Lethargy08.01.01.008; 19.04.04.004; 17.02.04.0030.000869%
Leukocytosis01.02.01.0020.000163%
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Ligament sprain15.07.02.004; 12.01.07.0080.000109%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000272%Not Available
Lipase increased13.05.01.0030.000217%
Listless19.04.04.003; 08.01.01.0120.000109%Not Available
Liver function test abnormal13.03.01.013--Not Available
Logorrhoea19.19.02.001; 17.02.08.0060.000706%Not Available
Loss of consciousness17.02.04.0040.002607%Not Available
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