Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Zolpidem tartrate
Drug ID BADD_D02395
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 D00706
MeSH ID D000077334
PubChem ID 18004026
TTD Drug ID D0T1WN
NDC Product Code 68071-1887; 51407-555; 70934-453; 71610-254; 16714-621; 71610-272; 50090-3879; 50090-4479; 53002-5020; 0955-1703; 63187-114; 63278-0490; 69654-510; 55700-573; 71335-1180; 70934-917; 61919-751; 0037-6050; 68071-5093; 72189-230; 49884-903; 43353-727; 42291-964; 71335-1801; 61919-449; 61919-812; 60760-515; 47335-308; 71610-152; 80425-0087; 68180-779; 12828-0086; 10370-116; 0093-0074; 55700-268; 80425-0061; 71610-156; 43353-242; 55700-777; 50090-5095; 67296-1591; 63187-707; 0904-6082; 65862-160; 10370-117; 80425-0060; 52286-0004; 51991-982; 68071-2642; 43386-762; 65015-767; 55111-479; 43353-243; 68071-5120; 42291-963; 0904-6083; 0024-5521; 55700-357; 68071-1895; 63629-3549; 66039-810; 70518-1663; 71205-286; 80425-0059; 68071-2354; 63629-4597; 68071-2232; 51407-554; 0781-5316; 60760-288; 0615-8226; 68071-5255; 71610-273; 40032-761; 70934-700; 0037-6010; 66039-938; 71610-151; 63187-558; 65862-345; 50090-3994; 60760-531; 62331-015; 80425-0165; 51991-981; 43063-639; 63629-8999; 13668-007; 71093-156; 68788-9127; 0093-0073; 63187-682; 70518-2917; 50090-1023; 63187-690; 68788-7407; 71335-0154; 68788-7422; 50090-5096; 68788-7903; 45865-413; 63187-565; 63187-862; 80425-0153; 61919-948; 71335-0283; 55289-205; 71610-192; 68788-8118; 68084-189; 71093-155; 0781-5317; 65862-159; 63739-526; 63415-0081; 55154-1398; 63629-4708; 63187-691; 0024-5421; 40032-762; 43063-652; 68071-4598; 61919-803; 70518-2865; 62704-0113; 71335-1468; 68071-5063; 53002-1292; 0781-5318; 59011-256; 45865-409; 16714-622; 0024-5501; 63629-8998; 13668-008; 68071-2450; 59011-255; 50090-1022; 71610-564; 49884-904; 63629-8163; 43386-761; 0781-5315; 47335-307; 68788-9126; 68788-7688; 68180-780; 61919-663; 53747-017; 0615-8225; 55111-478; 63629-1171; 0955-1702; 45865-956; 0024-5401; 50090-3878
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 C23H27N3O7
CAS Registry Number 99294-93-6
SMILES CC1=CC=C(C=C1)C2=C(N3C=C(C=CC3=N2)C)CC(=O)N(C)C.C(C(C(=O)O)O)(C(=O)O)O
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)
Pyelonephritis20.01.09.001; 11.01.14.002--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal pain20.02.03.003--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Saliva altered07.06.01.004--Not Available
Salivary hypersecretion07.06.01.009--Not Available
Sciatica17.10.03.001; 15.10.01.001--Not Available
Scleritis10.02.01.025; 06.04.07.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin wrinkling23.01.03.001--Not Available
Sleep disorder19.02.04.001--Not Available
Somnambulism19.02.03.006; 17.15.02.004--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder19.19.02.002; 17.02.08.003; 22.02.05.034--Not Available
Stress19.06.02.004--Not Available
Stupor19.02.05.004; 17.02.04.007--Not Available
Suicide attempt19.12.01.004--
Syncope17.02.04.008; 24.06.02.012; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Tendonitis15.07.01.003; 12.01.07.007--Not Available
Tetany15.05.03.013; 14.04.01.005; 05.04.02.003--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thirst08.01.09.021; 14.03.02.007--Not Available
Throat irritation22.02.05.013; 07.05.03.004--Not Available
Throat tightness22.02.05.015; 19.01.02.005--Not Available
Thrombosis24.01.01.006--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tremor17.01.06.002--
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