Dosing & Uses
Dosage Forms & Strengths
tablet, immediate-release: Schedule IV
- 5mg (Ambien)
- 10mg (Ambien)
tablet, extended-release: Schedule IV
- 6.25mg (Ambien CR)
- 12.5mg (Ambien CR)
tablet, sublingual: Schedule IV
- 1.75mg (Intermezzo)
- 3.5mg (Intermezzo)
- 5mg (Edluar)
- 10mg (Edluar)
oral spray: Schedule IV
- 5mg/spray (Zolpimist)
Immediate-release tablet, sublingual tablet, and oral spray
- Dosing for PO (Ambien), SL (Edluar), and oral spray (Zolpimist)
- Women: 5 mg PO/SL/oral spray qHS
- Men: Consider 5 mg PO/SL/oral spray qHS; may use 10 mg PO/SL/oral spray qHS if needed
Extended-release (Ambien CR)
- Women: 6.25 mg PO qHS
- Men: Consider 6.25 mg PO qHS; may use 12.5 mg PO qHS; not to exceed 12.5 mg/day
Insomnia when a middle of the night awakening is followed by difficulty returning to sleep
Women: 1.75 mg SL PRN; not to exceed 1 dose/night
Men: 3.5 mg SL PRN; not to exceed 1 dose/night
- Use only when ≥4 hours of bedtime remain before awakening
- Do not take if alcohol has been consumed or with any other sleep aid
- Concomitant with CNS depressants: 1.75 mg SL PRN; not to exceed 1 dose/night
Extended-release: Swallow whole, do not chew, crush, or split
- Dose adjustment may not be necessary; monitor
- Immediate-release: 5 mg immediately before bedtime
- Extended-release: 6.25 mg immediately before bedtime
- Sublingual (Edluar): 5 mg immediately before bedtime
- Sublingual (Intermezzo): 1.75 mg once at night if ≥4 hr remain before awakening
Drug of choice when hypnotic indicated in elderly
Immediate-release, oral spray: 5 mg PO/SL immediately before bedtime
Extended-release: 6.25 mg PO immediately before bedtime
Middle of the night awakening
Men and women: 1.75 mg SL PRN; not to exceed 1 dose/night
Extended-release: Swallow whole, do not chew, crush, or split
Intermezzo: Use only when ≥4 hours of bedtime remain before awakening; do not take if alcohol has been consumed or with any other sleep aid
Serious - Use Alternative
Significant - Monitor Closely
Memory disorder (3%)
Visual disturbance (3%)
Dry mouth (1%)
Flu-like symptoms (1%)
Sublingual tablet: Oral ulcers, blisters, and mucosal inflammation
Data show that zolpidem blood levels may remain high enough the morning after nighttime usage to impair activities that require alertness, including driving; this next-morning impairment is highest for the extended-release dosage form and is more prevalent in women because they eliminate more slowly than men
Use caution in patients with history of drug dependence (increases risk of abuse)
Food increases time to attain peak plasma level and decreases peak plasma concentration
Need to evaluate for comorbid diagnoses; reevaluate if insomnia persists after 7-10 days of use
Severe anaphylactic/anaphylactoid reactions including angioedema and anaphylaxis reported; do not rechallenge if such reactions occur
Abnormal thinking, behavioral changes, complex behaviors: May include “sleep driving” and hallucinations; coadministration of alcohol and other CNS depressants appears to increase the risk of such behaviors
Do not use with alcohol
Use can impair respiratory drive, alertness, and motor coordination; if used in combination with other CNS depressants, dose reductions of 50% may be needed due to additive effects
Consider risk of respiratory depression before prescribing in patients with compromised regulatory functions
Worsening of depression or suicidal thinking may occur; prescribe the least amount feasible to avoid intentional overdose
Withdrawal symptoms may occur with rapid dose reduction or discontinuation
Use lower dose in elderly/debilitated patients due to impaired motor, cognitive performance and increased sensitivity
Use with caution and monitor closely in patients with hepatic impairment, mild to moderate COPD, impaired drug metabolism or hemodynamic responses, or mild to moderate sleep apnea
Use with caution in patients with myasthenia gravis
Pregnancy & Lactation
Pregnancy category: C; cases of severe neonatal respiratory depression reported when zolpidem used near term, especially when taken with other CNS depressants
Lactation: Very low amounts secreted in breast milk; effect on infant unknown; use caution; advise mother to observe breastfeeding infant for lethargy, increased sedation, and changes in feeding habits
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Imidazopyridine; modulates omega-1 type GABA receptor via selective antagonism, resulting in increased chloride conductance, neuronal hyperpolarization, inhibition of action potential, and a decrease in neuronal excitability that in turn produce sedative and hypnotic effects
Peak plasma time: 1.6 hr (immediate-release); 1.5 hr (extended-release); 0.9 hr (spray); 1.4 hr (sublingual Edluar); 0.6-1.3 hr (sublingual Intermezzo)
Peak plasma time delayed by food intake
Peak plasma concentration: (5 mg dose) 59 ng/mL; (10 mg) 121 ng/mL; (12.5 mg CR) 134 ng/mL
Protein bound: 92.5%
Metabolized by CYP3A4 (60%), CYP2C9 (22%), CYP1A2 (14%), CYP2D6 (3%), CYP2C (3%)
Metabolized to inactive metabolites
- Immediate release: 2.5 hr (normal liver function); 9.9 hr (cirrhosis)
- Spray: 1.7-8.4 hr
- Sublingual: 1.4-6.7 hr
- Urine (48-67%)
- Feces (29-42%)
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