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)
Tonic clonic movements17.12.03.0060.000051%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000025%Not Available
Periventricular leukomalacia18.04.07.003; 17.13.02.0050.000089%Not Available
Drug tolerance08.06.01.0030.000285%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000051%Not Available
Exposure to toxic agent12.03.04.001--Not Available
Altered visual depth perception06.02.04.006; 17.17.01.002--Not Available
Affect lability19.04.01.001--Not Available
Myoclonic epilepsy17.12.03.0070.000076%Not Available
Gaze palsy17.02.05.044; 06.05.02.0140.000025%Not Available
Temperature intolerance08.01.09.0220.000069%Not Available
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000140%
Vascular dementia17.03.01.003; 24.04.06.017; 19.20.04.0010.000115%Not Available
Major depression19.15.01.0030.000064%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000217%Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Restless legs syndrome15.05.03.012; 17.02.07.0080.000130%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Extremity necrosis24.04.03.0120.000025%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Neurological symptom17.02.05.0100.000025%Not Available
Appetite disorder14.03.01.004; 19.09.01.002--Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
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