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)
Neurosis19.06.01.001--Not Available
Nocturia20.02.03.001--Not Available
Ocular hyperaemia06.04.05.004--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oesophageal spasm07.02.04.004--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Otitis externa11.01.05.003; 04.01.02.001--
Otitis media11.01.05.004; 04.05.01.001--
Pain08.01.08.004--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Palpitations02.01.02.003--
Panic attack19.06.04.001--Not Available
Paraesthesia17.02.06.005--
Paresis17.01.04.008--Not Available
Parosmia22.04.03.007; 17.04.04.002--Not Available
Periorbital oedema23.04.01.002; 10.01.05.010; 06.08.03.017--
Personality disorder19.05.02.002--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Phlebitis24.05.03.001; 12.02.01.002--
Photopsia17.17.01.006; 06.02.06.004--
Photosensitivity reaction23.03.09.003--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pollakiuria20.02.02.007--
Polyuria20.02.03.002--Not Available
Pruritus23.03.12.001--
Psychomotor retardation19.15.02.002--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
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