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  • Ambien CR
    (zolpidem tartrate)

    THERAPEUTIC CLASS

    Imidazopyridine hypnotic

    DEA CLASS

    CIV

    INDICATIONS

    Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

    ADULT DOSAGE

    Adults: Use lowest effective dose. Initial: 6.25mg for women and either 6.25mg or 12.5mg for men, taken only once per night immediately before hs with 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 qd immediately before hs. Elderly/Debilitated/Hepatic Insufficiency: 6.25mg qd immediately before hs. Use with CNS Depressants: May need to adjust dose.

    ADMINISTRATION

    Oral route. Swallow whole; do not divide, crush, or chew. Take immediately before hs with at least 7-8 hrs remaining before the planned time of awakening. Do not administer with or immediately after a meal.

    HOW SUPPLIED

    Tab, Extended-Release: 6.25mg, 12.5mg

    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 with less than a full night of sleep remaining (7-8 hrs). 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. Angioedema and anaphylaxis reported; do not rechallenge if such reactions develop. Abnormal thinking, behavior changes, and visual and auditory hallucinations reported. Complex behaviors (eg, sleep-driving) while not fully awake 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 primarily in depressed patients; prescribe the lowest feasible number of tabs at a time. Caution with compromised respiratory function; prior to prescribing, consider the risk of respiratory depression in patients with respiratory impairment (eg, sleep apnea, 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).

    ADVERSE REACTIONS

    Headache, somnolence, dizziness, anxiety, nausea, influenza, hallucinations, back pain, myalgia, fatigue, disorientation, memory disorder, visual disturbance, nasopharyngitis.

    DRUG INTERACTIONS

    See Dosage. Additive effects with other CNS depressants (eg, benzodiazepines, opioids, TCAs, alcohol), including daytime use. Use with other sedative-hypnotics (eg, other zolpidem products) at hs or the middle of the night is not recommended. Increased risk of next-day psychomotor impairment with other CNS depressants or drugs that increase zolpidem levels. Increased risk of complex behaviors with alcohol and other CNS depressants. May decrease peak levels of imipramine. Additive effect of decreased alertness with imipramine or chlorpromazine. Additive adverse effect on psychomotor performance with chlorpromazine or alcohol. Sertraline and CYP3A inhibitors may increase exposure. Fluoxetine may increase T1/2. Rifampin (a CYP3A4 inducer) may reduce exposure, pharmacodynamic effects, and efficacy. Ketoconazole (a potent CYP3A4 inhibitor) may increase pharmacodynamic effects; consider lower dose of zolpidem.

    PREGNANCY AND LACTATION

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Imidazopyridine, nonbenzodiazepine hypnotic; interacts with a gamma-aminobutyric acid-BZ receptor complex. Binds the BZ1 receptor preferentially with 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 angioedema, anaphylaxis, emergence of any new behavioral signs/symptoms of concern, respiratory depression, withdrawal signs/symptoms, tolerance, abuse, dependence, drowsiness, decreased level of consciousness, and other adverse reactions. Monitor for excess depressant effects.

    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).