Indications for AMBIEN CR:
Insomnia (w. difficulties in sleep onset and/or sleep maintenance).
Use lowest effective dose. Swallow whole. Effects delayed if taken with or after a meal. Take once per night immediately before bedtime (with at least 7–8hrs remaining before planned time of awakening). Women: initially 6.25mg. Men: initially 6.25mg or 12.5mg. Both: if 6.25mg ineffective, may increase to max 12.5mg. Elderly, debilitated, or mild to moderate hepatic impairment: 6.25mg.
<18yrs: not recommended.
Prior history of complex sleep behaviors with Ambien or Ambien CR.
Complex sleep behaviors.
Risk of complex sleep behaviors (eg, sleep-walking, sleep-driving, engaging in other activities while not fully awake); discontinue immediately if occur. Monitor for CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Evaluate any new onset of behavioral changes. Compromised respiratory function. Sleep apnea. Myasthenia gravis. Drug or alcohol abuse. Avoid in severe hepatic impairment; may contribute to encephalopathy. Avoid abrupt cessation. Write ℞ for smallest practical amount. Elderly (higher risk of falls). Debilitated. Pregnancy: monitor neonates. Nursing mothers: monitor infants (consider interrupting breastfeeding or pumping/discarding breast milk during and for 23hrs after administration).
Concomitant other sedative-hypnotics including other zolpidem products: not recommended. Potentiates CNS depression with alcohol, other CNS depressants (eg, benzodiazepines, opioids, tricyclics); adjust dose. May be potentiated by CYP3A4 inhibitors (eg, ketoconazole; consider lower zolpidem dose), sertraline. May be antagonized by CYP3A4 inducers (eg, rifampin, St. John's wort); avoid concomitant use. Decreased alertness with imipramine, chlorpromazine.
Headache, next-day somnolence, drowsiness, dizziness, diarrhea, drugged feelings (long-term); abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).
CR tabs—100; tabs—100