zolpidem (Rx)

Brand and Other Names:Ambien, Ambien CR, more...Edluar, Intermezzo, Zolpimist
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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

Dosing considerations (Ambien, Ambien CR)

  • Use lowest effective dose; take only once per night immediately before bedtime with at least 7-8 hr remaining before the planned time of awakening
  • In some patients, higher morning blood levels following use of 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness
  • Total dose should not exceed 10 mg once daily immediately before bedtime; should be taken as single dose and should not be readministered during same night

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 (Intermezzo)

  • Use only when ≥4 hr 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

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

Dosing Considerations

Ambien, Ambien CR: Use lowest effective dose; take only once per night immediately before bedtime with at least 7-8 hr remaining before the planned time of awakening

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

and zolpidem

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    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

            Liver and biliary system: Acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin greater than 2x ULN, alkaline phosphatase greater than or equal to 2x ULN, transaminase greater than or equal to 5x ULN).

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            Warnings

            Contraindications

            Contraindicated in patients with known hypersensitivity to zolpidem; observed reactions include anaphylaxis and angioedema

            Cautions

            The risk of next-day psychomotor impairment, including impaired driving, is increased if taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or if co-administered with other drugs that increase blood levels of zolpidem; patients should be warned against driving and other activities requiring complete mental alertness if drug taken in these circumstances

            Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression; dosage adjustments of zolpidem and of other concomitant CNS depressants may be necessary when zolpidem is administered with such agents because of the potentially additive effects; the use of zolpidem with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended

            Vehicle drivers and machine operators should be warned that, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness and impaired driving the morning after therapy; to minimize risk, a full night of sleep (7-8 hours) recommended; 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

            Can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries; severe injuries such as hip fractures and intracranial hemorrhage have been reported

            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

            GABA agonists such as zolpidem tartrate have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency; patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function; avoid zolpidem use in patients with severe hepatic impairment as it may contribute to encephalopathy

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            Pregnancy & Lactation

            Pregnancy

            Neonates born to mothers using zolpidem late in the third trimester of pregnancy reported to experience symptoms of respiratory depression and sedation; published data on use of zolpidem during pregnancy have not reported clear association with zolpidem and major birth defects

            There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy; these cases required artificial ventilation or intratracheal intubation; the majority of neonates recovered within hours to a few weeks after birth once treated Zolpidem has been shown to cross the placenta

            Animal data

            • Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses

            Lactation

            Limited data report presence of zolpidem in human milk; there are reports of excess sedation in infants exposed to zolpidem through breastmilk; there is no information on effects on milk production; consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Monitor, for excess sedation, infants exposed to drug through breastmilk, hypotonia, and respiratory depression; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after drug administration in order to minimize drug exposure to a breast fed infant

            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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            Administration

            Oral Administration

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

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            Images

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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.