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)
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Varicose vein24.10.04.001--Not Available
Ventricular tachycardia02.03.04.010--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred06.02.06.007; 17.17.01.010--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.003--
Vulvovaginal dryness21.08.02.003--
Weight decreased13.15.01.005--
Yawning22.02.05.017--Not Available
Red blood cell sedimentation rate increased13.01.03.001--Not Available
Balance disorder17.02.02.007--Not Available
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.001--
Drug tolerance increased08.06.01.004--Not Available
Exposure to toxic agent12.03.04.001--Not Available
Altered visual depth perception17.17.01.002; 06.02.04.006--Not Available
Affect lability19.04.01.001--Not Available
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Hot flush21.02.02.001; 24.03.01.005; 08.01.03.027--
Appetite disorder19.09.01.002; 14.03.01.004--Not Available
Poisoning12.03.01.004--Not Available
Abnormal behaviour19.01.01.001--Not Available
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