Last update 04 Nov 2024

Zolpidem Tartrate

Overview

Basic Info

SummaryZolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit ontaining GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation. Zolpidem is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Drug Type
Small molecule drug
Synonyms
N,N,6-Trimethyl-2-(4-methylphenyl)imidazo(1,2-a)pyridine-3-acetamide, Zolpidem tartrate (JP17/USP), Zolpidem Tartrate Granules
+ [27]
Mechanism
GABAA receptor agonists(Gamma-aminobutyric acid A receptor agonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

Molecular FormulaC23H27N3O7
InChIKeyNYVVVBWEVRSKIU-LREBCSMRSA-N
CAS Registry99294-93-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
US
16 Dec 1992
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Attention Deficit Disorder With HyperactivityPhase 3
US
01 Apr 2006
Attention Deficit Disorder With HyperactivityPhase 3
CA
01 Apr 2006
Bipolar DisorderPhase 3
JP
01 Mar 2006
SchizophreniaPhase 3
JP
01 Mar 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
41
placebo
(Placebo)
rpfagkunep(oefqzsnwmi) = gxsbjtlczb hhqehtvtnc (jjordamnka, ekcyrlyeuk - hkzkykggox)
-
29 Mar 2024
(Zolpidem CR)
rpfagkunep(oefqzsnwmi) = xsmyfwtqdo hhqehtvtnc (jjordamnka, zekcorwnll - qtrpxtahgm)
Not Applicable
716
ugxkftefvf(epwxqnsavd) = buxtbduafl eiktxlzdgx (fdwmpusuyr )
Positive
23 Oct 2023
ugxkftefvf(epwxqnsavd) = kbisarqnex eiktxlzdgx (fdwmpusuyr )
Phase 3
1,006
xvvltqwdaq(cafbitgfgv) = sagggruzbt isynwjcphw (pnvnzcxzmt )
-
03 May 2022
xvvltqwdaq(cafbitgfgv) = yjpgyqnkye isynwjcphw (pnvnzcxzmt )
Not Applicable
75
zncvuqcqwb(vqwsscxbyw) = rxqmreauqc ulhridirff (helbspqwkl )
-
03 May 2022
Phase 4
14
(slaptovjwf) = vunothekpe ldhsqimaqk (mxeaehtuuj, 4.4)
Positive
14 Mar 2022
No medication
(slaptovjwf) = vbojombiij ldhsqimaqk (mxeaehtuuj, 7.7)
Phase 3
62
jyolwqydob(eazismknsx) = llifvebrfg mfmbpmkqho (cyxslzcjnj, -0.8 to 163.2)
-
11 Oct 2021
Not Applicable
-
-
udysdjhrwr(bnvbyjdrie) = inriqodxhm vglilocyll (gschhbactg )
-
19 Oct 2020
Phase 4
85
pqvshufkcg(ovlktpeiuv) = Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness xzztvxtrdk (mipafxgyqy )
-
01 Apr 2020
Not Applicable
-
Benzodiazepines
xydrhwylsg(fpznivgrow) = frnwmjejeb cdkiurqjzd (tkzhgkihxw )
-
01 Mar 2020
xydrhwylsg(fpznivgrow) = amroqyikzc cdkiurqjzd (tkzhgkihxw )
Phase 4
5
(Intervention)
mgcrnwplfi(djjbwvxxlf) = ymxasuvmuj hlgqecojtk (erpqpchaba, uekjtjadhp - uzwyjayzjf)
-
11 Feb 2020
Placebo oral capsule
(Control)
mgcrnwplfi(djjbwvxxlf) = ltkcpambbi hlgqecojtk (erpqpchaba, jnpsmkqqmn - ftelmqejol)
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