Drugs & Diseases zolpidem (Rx) Brand and Other Names: Ambien, Ambien CR, more. processing. Edluar, Intermezzo, Zolpimist Classes: Sedative/Hypnotics ; Insomnia Share Print Feedback Close Facebook Twitter LinkedIn Google+ Sections zolpidem (Rx) Sections zolpidem Dosing & Uses Interactions Adverse Effects Warnings Pregnancy Pharmacology Administration Images Patient Handout Formulary Dosing & Uses Adult Pediatric Geriatric Dosage Forms & Strengths tablet, immediate-release: Schedule IV.
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tablet, sublingual: Schedule IV.
Use can impair respiratory drive, alertness, and motor coordination; if used in combination with other CNS depressants, dose reductions of 50% may be needed due to additive effects.
Extended-release tablet: Swallow whole; do not chew, crush, or split.
Immediate-release, oral spray: 5 mg PO/SL immediay before bedtime.
Abnormal thinking, behavioral changes, complex behaviors: May include “sleep driving” and hallucinations; coadministration of alcohol and other CNS depressants appears to increase the risk of such behaviors.
Extended-release: 6.25 mg PO immediay before bedtime.
Pregnancy category: C; cases of severe neonatal respiratory depression reported when zolpidem used near term, especially when taken with other CNS depressants.
tablet, extended-release: Schedule IV.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
Metabolized to inactive metabolites Half-life Excretion.
Men and women: 1.75 mg SL PRN; not to exceed 1 dose/night.
Men: 3.5 mg SL PRN; not to exceed 1 dose/night Dosing considerations (Intermezzo) Renal impairment Hepatic impairment Not recommended.
Metabolized by CYP3A4 (60%), CYP2C9 (22%), CYP1A2 (14%), CYP2D6 (3%), CYP2C (3%).
Use caution in patients with history of drug dependence (increases risk of abuse).
Contraindicated in patients with known hypersensitivity to zolpidem; observed reactions include anaphylaxis and angioedema.
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C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
Withdrawal symptoms may occur with rapid dose reduction or discontinuation.
Do not use with alcohol.
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Can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries; severe injuries such as hip fractures and intracranial hemorrhage have been reported.
Lactation: Very low amounts secreted in breast milk; effect on infant unknown; use caution; advise mother to observe breastfeeding infant for lethargy, increased sedation, and changes in feeding habits.
Intermezzo: Use only when ≥4 hours of bedtime remain before awakening; do not take if alcohol has been consumed or with any other sleep aid No Results Dizziness (5-12%) Headache (7-19%) Drowsiness (6-15%) Allergy (4%) Hallucinations (4%) Myalgia (4%) Sinusitis (4%) Memory disorder (3%) Visual disturbance (3%) Pharyngitis (3%) Lightheadedness (2%) Palpitation (2%) Rash (2%) Constipation (2%) Depression (2%) Drowsiness (2%) Asthenia (1%) Diarrhea (1%) Dry mouth (1%) Flu-like symptoms (1%) Respiratory depression.
Peak plasma time delayed by food intake.
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Peak plasma concentration: (5 mg dose) 59 ng/mL; (10 mg) 121 ng/mL; (12.5 mg CR) 134 ng/mL Protein bound: 92.5%
Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression; dosage adjustments of zolpidem and of other concomitant CNS depressants may be necessary when zolpidem is administered with such agents because of the potentially additive effects; the use of zolpidem with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.
Peak plasma time: 1.6 hr (immediate-release); 1.5 hr (extended-release); 0.9 hr (spray); 1.4 hr (sublingual Edluar); 0.6-1.3 hr (sublingual Intermezzo).
Ambien, Ambien CR: Use lowest effective dose; take only once per night immediay before bedtime with at least 7-8 hr remaining before the planned time of awakening.
oral spray: Schedule IV Sleep initiation.
Severe anaphylactic/anaphylactoid reactions including angioedema and anaphylaxis reported; do not rechallenge if such reactions occur.
Use with caution and monitor closely in patients with hepatic impairment, mild to moderate COPD, impaired drug metabolism or hemodynamic responses, or mild to moderate sleep apnea.
Sublingual tablet: Oral ulcers, blisters, and mucosal inflammation.
Dosing considerations (Ambien, Ambien CR).
Drug of choice when hypnotic indicated in elderly Sleep initiation.
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No Results No Results.
Imidazopyridine; modulates omega-1 type GABA receptor via selective antagonism, resulting in increased chloride conductance, neuronal hyperpolarization, inhibition of action potential, and a decrease in neuronal excitability that in turn produce sedative and hypnotic effects Bioavailability: 70%
Use lower dose in elderly/debilitated patients due to impaired motor, cognitive performance and increased sensitivity.
Consider risk of respiratory depression before prescribing in patients with compromised regulatory functions.
The risk of next-day psychomotor impairment, including impaired driving, is increased if taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or if co-administered with other drugs that increase blood levels of zolpidem; patients should be warned against driving and other activities requiring complete mental alertness if drug taken in these circumstances.
Food increases time to attain peak plasma level and decreases peak plasma concentration.
Need to evaluate for comorbid diagnoses; reevaluate if insomnia persists after 7-10 days of use.
Controlled studies in pregnant women show no evidence of fetal risk. A: Generally acceptable.
GABA agonists such as zolpidem tartrate have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency; patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function; avoid zolpidem use in patients with severe hepatic impairment as it may contribute to encephalopathy.
Vehicle drivers and machine operators should be warned that, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness and impaired driving the morning after therapy; to minimize risk, a full night of sleep (7-8 hours) recommended; this next-morning impairment is highest for the extended-release dosage form and is more prevalent in women because they eliminate more slowly than men.
Women: 1.75 mg SL PRN; not to exceed 1 dose/night.
NA: Information not available.
Liver and biliary system: Acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin greater than 2x ULN, alkaline phosphatase greater than or equal to 2x ULN, transaminase greater than or equal to 5x ULN).
Use with caution in patients with myasthenia gravis.
Positive evidence of human fetal risk. D: Use in LIFE-THREATENING emergencies when no safer drug available.
Worsening of depression or suicidal thinking may occur; prescribe the least amount feasible to avoid intentional overdose.
Immediate-release tablet, sublingual tablet, and oral spray Extended-release (Ambien CR).
X: Do not use in pregnancy. Safer alternatives exist. Risks involved outweigh potential benefits.
Insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
Middle of the night awakening.Zolpidem