AMBIEN CR CIV
Generic Name and Formulations:
Zolpidem tartrate 6.25mg, 12.5mg; ext-rel tabs.
Indications for AMBIEN CR:
Swallow whole. Use lowest effective dose. Initially 6.25mg (in women), and 6.25mg or 12.5mg (in men) at bedtime (take only if able to get 7–8hrs of sleep before becoming active again). Both: if 6.25mg dose ineffective, may increase to max 12.5mg. Elderly, debilitated, or mild-to-moderate hepatic impairment: 6.25mg once daily at bedtime. Effect delayed if taken with a meal.
<18yrs: not recommended.
Increased risk of next-day psychomotor impairment. Depression. Abnormal thinking and behavioral changes. Compromised respiratory function. Sleep apnea. Myasthenia gravis. Avoid in severe hepatic impairment; may contribute to encephalopathy. Evaluate for co-morbid diagnoses before initiation. Reevaluate if insomnia persists after 7–10 days of use. Drug or alcohol abuse. Write ℞ for smallest practical amount. Withdraw gradually. Elderly. Debilitated. Labor & delivery. Neonates. Pregnancy. Nursing mothers: monitor infants; may consider pumping/discarding breast milk during and for 23hrs after administration.
Concomitant other sedative-hypnotics including other zolpidem products: not recommended. Increased risk of CNS depression, drowsiness, psychomotor impairment with alcohol, other CNS depressants (eg, benzodiazepines, opioids, tricyclics). May be potentiated by CYP3A4 inhibitors (eg, ketoconazole), sertraline; use lower zolpidem dose. Decreased alertness with imipramine, chlorpromazine. May be antagonized by CYP3A4 inducers (eg, rifampin, St. John's wort); avoid concomitant use.
Headache, next-day somnolence, drowsiness, dizziness, diarrhea, dry mouth; CNS effects, complex sleep-related behaviors (eg, sleep-driving), anaphylaxis, angioedema.
CR tabs 6.25mg—100; 12.5mg—100, 500; tabs 5mg—100; 10mg—100, 500
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