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Zolpidem Sublingual Tablets Generic Name & Formulations
Legal Class
CIV
General Description
Zolpidem tartrate 1.75mg, 3.5mg.
Pharmacological Class
Imidazopyridine hypnotic.
How Supplied
Contact supplier
Manufacturer
Zolpidem Sublingual Tablets Indications
Indications
As needed treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Limitations of Use
Not indicated for treatment of middle-of-the-night insomnia when patient has <4hrs of bedtime remaining before planned time of waking.
Zolpidem Sublingual Tablets Dosage and Administration
Adult
Use lowest effective dose. Effects delayed if taken with or after a meal. Place 1 tab under the tongue and allow to disintegrate completely before swallowing. Take only once per night as needed (with at least 4hrs of bedtime remaining before planned time of waking). Women: 1.75mg. Men: 3.5mg. Concomitant CNS depressants, elderly (≥65yrs), hepatic impairment: 1.75mg.
Children
<18yrs: not recommended.
Zolpidem Sublingual Tablets Contraindications
Contraindications
Prior history of complex sleep behaviors with zolpidem SL tabs.
Zolpidem Sublingual Tablets Boxed Warnings
Boxed Warning
Complex sleep behaviors.
Zolpidem Sublingual Tablets 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. Hepatic impairment. Avoid abrupt cessation. Write ℞ for smallest practical amount. Elderly (higher risk of falls). Debilitated. Pregnancy (Cat.C). Nursing mothers.
Zolpidem Sublingual Tablets Pharmacokinetics
See Literature
Zolpidem Sublingual Tablets 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 be potentiated by CYP3A4 inhibitors (eg, ketoconazole; consider lower zolpidem dose), sertraline. May be antagonized by CYP3A4 inducers (eg, rifampin). Decreased alertness with imipramine, chlorpromazine.
Zolpidem Sublingual Tablets Adverse Reactions
Adverse Reactions
Headache, nausea, fatigue; abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).
Zolpidem Sublingual Tablets Clinical Trials
See Literature
Zolpidem Sublingual Tablets Note
Notes
Formerly known under the brand name Intermezzo.
Zolpidem Sublingual Tablets Patient Counseling
See Literature
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