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zolpidem (Rx)Brand and Other Names:Ambien, Ambien CR, more...Edluar, Intermezzo, Zolpimist

 
 
 

Dosing & Uses

AdultPediatricGeriatric

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)
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Insomnia

Sleep initiation

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 (Intermezzo)

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

Dosing considerations

  • 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

Administration

Extended-release: Swallow whole, do not chew, crush, or split

Dosing Modifications

Renal impairment

  • Dose adjustment may not be necessary; monitor

Hepatic impairment

  • 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

Not recommended

Drug of choice when hypnotic indicated in elderly

Insomnia

Sleep initiation

Immediate-release, oral spray: 5 mg PO/SL immediately before bedtime

Extended-release: 6.25 mg PO immediately before bedtime

Insomnia (Intermezzo)

Middle of the night awakening

Men and women: 1.75 mg SL PRN; not to exceed 1 dose/night

Administration

Extended-release: Swallow whole, do not chew, crush, or split

Dosing Considerations

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

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Interactions

Interaction Checker

zolpidem and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (5-12%)

            Headache (7-19%)

            Drowsiness (6-15%)

            1-10%

            Allergy (4%)

            Hallucinations (4%)

            Myalgia (4%)

            Sinusitis (4%)

            Memory disorder (3%)

            Visual disturbance (3%)

            Pharyngitis (3%)

            Lightheadedness (2%)

            Palpitation (2%)

            Rash (2%)

            Constipation (2%)

            Depression (2%)

            Drowsiness (2%)

            Asthenia (1%)

            Diarrhea (1%)

            Dry mouth (1%)

            Flu-like symptoms (1%)

            Postmarketing reports

            Respiratory depression

            Sublingual tablet: Oral ulcers, blisters, and mucosal inflammation

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            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

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            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

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Absorption

            Bioavailability: 70%

            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

            Distribution

            Protein bound: 92.5%

            Metabolism

            Metabolized by CYP3A4 (60%), CYP2C9 (22%), CYP1A2 (14%), CYP2D6 (3%), CYP2C (3%)

            Metabolized to inactive metabolites

            Elimination

            Half-life

            • Immediate release: 2.5 hr (normal liver function); 9.9 hr (cirrhosis)
            • Spray: 1.7-8.4 hr
            • Sublingual: 1.4-6.7 hr

            Excretion

            • Urine (48-67%)
            • Feces (29-42%)
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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