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  • Ambien CR
    (zolpidem tartrate)

    THERAPEUTIC CLASS

    GABAA agonist

    DEA CLASS

    CIV

    ADULT DOSAGE & INDICATIONS

    Insomnia

    Treatment of Insomnia Characterized by Difficulties w/ Sleep Onset and/or Sleep Maintenance:
    Initial: 6.25mg (women), and either 6.25mg or 12.5mg (men), taken qhs w/ at least 7-8 hrs remaining before the planned time of awakening
    Titrate: May increase to 12.5mg if the 6.25mg dose is not effective
    Max: 12.5mg qhs

    DOSING CONSIDERATIONS

    Concomitant Medications
    CNS Depressants: May need to adjust dose of zolpidem and concomitant CNS depressant

    Hepatic Impairment
    6.25mg qhs

    Elderly
    Elderly/Debilitated: 6.25mg qhs

    ADMINISTRATION

    Oral route

    Swallow whole; do not divide, crush, or chew.
    Take immediately before hs w/ at least 7-8 hrs remaining before the planned time of awakening.
    Take as a single dose and do not readminister during the same night.
    Do not administer w/ or immediately after a meal; effect of zolpidem may be slowed.

    HOW SUPPLIED

    Tab, Extended-Release: 6.25mg, 12.5mg

    CONTRAINDICATIONS

    Known hypersensitivity to zolpidem.

    WARNINGS/PRECAUTIONS

    May impair daytime function; monitor for excess depressant effects. May impair mental/physical abilities. Increased risk of next-day psychomotor impairment if taken w/ less than a full night of sleep remaining (7-8 hrs), or if higher than the recommended dose is taken. Initiate only after careful evaluation; failure of insomnia to remit after 7-10 days of treatment may indicate presence of a primary psychiatric and/or medical illness. Cases of angioedema involving the tongue, glottis, or larynx reported; do not rechallenge if angioedema develops. Abnormal thinking, behavior changes, and visual and auditory hallucinations reported. Complex behaviors (eg, sleep-driving) reported; consider discontinuation if a sleep-driving episode occurs. Amnesia, anxiety, and other neuropsychiatric symptoms may occur. Worsening of depression and suicidal thoughts and actions (including completed suicides) reported in primarily depressed patients; prescribe the least amount of drug that is feasible at any one time. Respiratory insufficiency reported, mostly in patients w/ preexisting respiratory impairment; caution w/ compromised respiratory function, including sleep apnea and myasthenia gravis. Withdrawal signs and symptoms reported following rapid dose decrease or abrupt discontinuation; monitor for tolerance, abuse, and dependence. May cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries (eg, hip fractures, intracranial hemorrhage). Zolpidem clearance is lower in women.

    ADVERSE REACTIONS

    Headache, next-day somnolence, dizziness.

    DRUG INTERACTIONS

    See Dosing Considerations. Additive effects w/ other CNS depressants (eg, benzodiazepines, opioids, TCAs, alcohol), including daytime use; consider downward dose adjustment of zolpidem and concomitant CNS depressant. Use w/ other sedative-hypnotics (eg, other zolpidem products) at hs or in the middle of the night is not recommended. Increased risk of next-day psychomotor impairment if coadministered w/ other CNS depressants or alcohol, or drugs that increase zolpidem levels. Increased risk of complex behaviors w/ alcohol and other CNS depressants. May decrease peak levels of imipramine. Additive effect of decreased alertness w/ imipramine or chlorpromazine. Additive adverse effect on psychomotor performance w/ chlorpromazine or alcohol. Sertraline increases exposure to zolpidem. Fluoxetine may increase T1/2. CYP3A inducers or inhibitors may affect exposure to zolpidem. Rifampin (a CYP3A4 inducer) significantly reduced exposure and the pharmacodynamic effects of zolpidem; concomitant use w/ CYP3A4 inducers may decrease the efficacy of zolpidem. Ketoconazole (a potent CYP3A4 inhibitor) increased exposure and pharmacodynamic effects of zolpidem; consider using a lower dose of zolpidem when administered together w/ a potent CYP3A4 inhibitor.

    PREGNANCY AND LACTATION

    Pregnancy: Category C. Cases of severe neonatal respiratory depression reported when zolpidem was used at the end of pregnancy, especially when taken w/ other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period.
    Lactation: Excreted in human milk. Caution in nursing.

    MECHANISM OF ACTION

    Imidazopyridine, nonbenzodiazepine hypnotic; interacts w/ a gamma-aminobutyric acid-BZ receptor complex. Binds the BZ1 receptor preferentially w/ a high affinity ratio of the α15 subunits.

    PHARMACOKINETICS

    Absorption: Biphasic. Cmax=134ng/mL; Tmax=1.5 hrs (median); AUC=740ng•hr/mL. Distribution: Plasma protein binding (92.5%); found in breast milk. Elimination: Renal; T1/2=2.8 hrs.

    ASSESSMENT

    Assess for physical and/or psychiatric disorder, depression, compromised respiratory function, sleep apnea, myasthenia gravis, hepatic impairment, history of drug/alcohol addiction or abuse, hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for CNS depression, angioedema, abnormal thinking, behavioral changes, visual/auditory hallucinations, complex behaviors, worsening of depression, suicidal thoughts/actions, respiratory depression, and other adverse reactions. Monitor for withdrawal signs/symptoms following rapid dose decrease or abrupt discontinuation.

    PATIENT COUNSELING

    Inform about the benefits and risks of treatment. Instruct to take only as prescribed. Caution against driving and other activities requiring complete mental alertness the day after use. Instruct to contact physician immediately if any adverse reactions (eg, severe anaphylactic/anaphylactoid reactions, sleep-driving, other complex behaviors, suicidal thoughts) develop. Advise not to use the drug if patient drank alcohol that pm or before bed. Instruct not to increase the dose and to inform physician if it is believed that the drug does not work.

    STORAGE

    15-25°C (59-77°F); limited excursions permissible up to 30°C (86°F).