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Ambien Cr Generic Name & Formulations
Legal Class
CIV
General Description
Zolpidem tartrate 6.25mg, 12.5mg; ext-rel tabs.
Pharmacological Class
Imidazopyridine hypnotic.
See Also
How Supplied
CR tabs—100; tabs—100
Manufacturer
Generic Availability
YES
Ambien Cr Indications
Indications
Insomnia (w. difficulties in sleep onset and/or sleep maintenance).
Ambien Cr Dosage and Administration
Adult
Use lowest effective dose for shortest duration. 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.
Children
<18yrs: not recommended.
Ambien Cr Contraindications
Contraindications
Prior history of complex sleep behaviors with Ambien or Ambien CR.
Ambien Cr Boxed Warnings
Boxed Warning
Complex sleep behaviors.
Ambien Cr Warnings/Precautions
Warnings/Precautions
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).
Ambien Cr Pharmacokinetics
See Literature
Ambien Cr Interactions
Interactions
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 increase risk of respiratory depression with opioids; limit dose/duration of concomitant use. 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.
Ambien Cr Adverse Reactions
Adverse Reactions
Headache, next-day somnolence, drowsiness, dizziness, diarrhea, drugged feelings (long-term); abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).
Ambien Cr Clinical Trials
See Literature
Ambien Cr Note
Not Applicable
Ambien Cr Patient Counseling
See Literature
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