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Comprehensive categorization: +GABAA Positive Allosteric Modulators (General), GABAergics
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{{MedTemplate
{{MedTemplate
| generic           = Zolpidem
| generic           = Zolpidem (tartrate)
| brand             = Ambien
| brand             = Ambien (IR), Ambien CR (biphasic-release), Edluar (sublingual), Intermezzo (low-dose sublingual for middle-of-night awakening), Zolpimist (oral spray)
| structure         =  
| structure         =
| classes           = Z-drug, Sedative-Hypnotic
| classes           = [[:Category:Non-benzodiazepine hypnotics|Non-benzodiazepine hypnotic]], [[:Category:Sleep aids|Sleep aid]], [[:Category:Schedule IV controlled substances|Schedule IV controlled substance]]
| mechanism          = GABAA positive allosteric modulator (non-benzodiazepine)
| uses              = <vote slug="insomnia-sleep-onset-use">Insomnia, sleep-onset type (FDA, short-term)</vote>, <vote slug="insomnia-sleep-maintenance-use">Insomnia, sleep-maintenance type (Ambien CR; FDA)</vote>, <vote slug="middle-of-night-awakening-use">Middle-of-night awakening with ≥4 hours sleep remaining (Intermezzo SL; FDA)</vote>
| uses              =  
| starting_dose    = '''5 mg PO at bedtime for women, 5-10 mg for men''' (per FDA's 2013 sex-specific dose reduction for women due to slower clearance). Ambien CR 6.25 mg women / 6.25-12.5 mg men. Intermezzo SL 1.75 mg women / 3.5 mg men
| starting_dose     =  
| preparations     = IR tablets 5, 10 mg; CR tablets 6.25, 12.5 mg; SL tablets 1.75, 3.5, 5, 10 mg; oral spray
| preparations      =  
| fda_max          = 10 mg/day (IR); 12.5 mg/day (CR)
| fda_max           =  
| pill_id           =
| routes             =  
| routes           = Oral, sublingual, oromucosal spray
| onset             =  
| onset             = 15-30 minutes
| duration           =  
| duration         = 6-8 hours (IR); 8 hours (CR via biphasic release)
| halflife           =
| halflife          = ~2.5 hours<ref name="ambien-label">FDA Prescribing Information, Ambien (zolpidem tartrate), Sanofi, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s041lbl.pdf</ref>
| bioavailability    =
| bioavailability   = ~70% (oral)<ref name="ambien-label" />
| pregnancy         =  
| pregnancy        = Limited human data; case reports of neonatal sedation with late-pregnancy exposure.{{citation needed}}
| legal              =  
| legal             = [[USLegal:Schedule IV|Schedule IV controlled substance]] in US. Carries the FDA '''Boxed Warning''' for '''complex sleep behaviors''' (sleep-driving, sleep-walking, sleep-eating, other parasomnias) added in 2019<ref name="ambien-label" />
| intro              =
| mechanism         = <vote slug="zolpidem-mech-claim">Selective positive allosteric modulator of the GABA-A receptor preferentially at α1-containing subtypes (the "sedation" subtypes), providing more sedation per unit anxiolysis and muscle relaxation than the non-selective benzodiazepines. The short half-life is the basis of less next-morning grogginess in most patients.</vote> The 2013 FDA dose reduction for women reflects slower clearance in women and higher rates of next-morning impaired driving; the 2019 Boxed Warning for complex sleep behaviors followed accumulated case reports. CYP3A4 substrate, so CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) substantially raise plasma exposure<ref name="ambien-label" />.
| pharmacokinetics   =  
| pharmacodynamics  =  
| indications        =  
| dosing             =  
| effects            =  
| interactions      = <pharmaInteractions/>
| pregnancy_details  =
| monitoring         =  
| counseling        =  
| anecdotes          =
| seealso            =
| references        =  
}}
}}


== References ==
<references />


[[Category:Anxiolytics & Sedative-Hypnotics]]
[[Category:Non-benzodiazepine hypnotics]]
[[Category:Z-Drugs (Non-Benzodiazepine Hypnotics)]]
[[Category:Sleep aids]]
[[Category:Sedative-Hypnotics]]
[[Category:Schedule IV controlled substances]]
[[Category:GABAA Positive Allosteric Modulators (General)]]
[[Category:GABAergics]]

Latest revision as of 06:40, 23 May 2026

Non-benzodiazepine hypnotic, Sleep aid, Schedule IV controlled substance
Zolpidem (tartrate)
Ambien (IR), Ambien CR (biphasic-release), Edluar (sublingual), Intermezzo (low-dose sublingual for middle-of-night awakening), Zolpimist (oral spray)

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Problems

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Titration strategies

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Summary
Classes
Non-benzodiazepine hypnotic, Sleep aid, Schedule IV controlled substance
Common uses
Insomnia, sleep-onset type (FDA, short-term)0, Insomnia, sleep-maintenance type (Ambien CR; FDA)0, Middle-of-night awakening with ≥4 hours sleep remaining (Intermezzo SL; FDA)0
Pharmacy
Starting dose
5 mg PO at bedtime for women, 5-10 mg for men (per FDA's 2013 sex-specific dose reduction for women due to slower clearance). Ambien CR 6.25 mg women / 6.25-12.5 mg men. Intermezzo SL 1.75 mg women / 3.5 mg men
Preparations
IR tablets 5, 10 mg; CR tablets 6.25, 12.5 mg; SL tablets 1.75, 3.5, 5, 10 mg; oral spray
US FDA Max
10 mg/day (IR); 12.5 mg/day (CR)
Pharmacology
Routes
Oral, sublingual, oromucosal spray
Onset
15-30 minutes
Duration
6-8 hours (IR); 8 hours (CR via biphasic release)
Half-life
~2.5 hours[1]
Bioavailability
~70% (oral)[1]
Pregnancy
Limited human data; case reports of neonatal sedation with late-pregnancy exposure.[citation needed]
Legal status
Schedule IV controlled substance in US. Carries the FDA Boxed Warning for complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating, other parasomnias) added in 2019[1]
Purported mechanism
Selective positive allosteric modulator of the GABA-A receptor preferentially at α1-containing subtypes (the "sedation" subtypes), providing more sedation per unit anxiolysis and muscle relaxation than the non-selective benzodiazepines. The short half-life is the basis of less next-morning grogginess in most patients.0 The 2013 FDA dose reduction for women reflects slower clearance in women and higher rates of next-morning impaired driving; the 2019 Boxed Warning for complex sleep behaviors followed accumulated case reports. CYP3A4 substrate, so CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) substantially raise plasma exposure[1].

References

  1. ↑ 1.0 1.1 1.2 1.3 FDA Prescribing Information, Ambien (zolpidem tartrate), Sanofi, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s041lbl.pdf
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