Generic Name and Formulations:
Zolpidem tartrate 5mg, 10mg; tabs.
Indications for AMBIEN:
Use lowest effective dose. Initially 5mg (in women), and 5mg or 10mg (in men) at bedtime (take only if able to get 7–8hrs of sleep before becoming active again). Both: if 5mg dose ineffective, may increase to max 10mg. Elderly, debilitated, or mild-to-moderate hepatic impairment: 5mg 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. Pregnancy (Cat.C). Nursing mothers.
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.
CNS effects, complex sleep-related behaviors (eg, sleep-driving), headache, next-day somnolence, drowsiness, dizziness, diarrhea, dry mouth; anaphylaxis, angioedema.
CR tabs 6.25mg—100; 12.5mg—100, 500; tabs 5mg—100; 10mg—100, 500
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