Sleep-wake disorders:

Indications for: Zolpidem Sublingual Tablets

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.

Adult Dosage:

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 Dosage:

<18yrs: not recommended.

Zolpidem Sublingual Tablets Contraindications:

Prior history of complex sleep behaviors with zolpidem SL tabs.

Boxed Warning:

Complex sleep behaviors.

Zolpidem Sublingual Tablets 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 Classification:

Imidazopyridine hypnotic.

Zolpidem Sublingual Tablets 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.

Adverse Reactions:

Headache, nausea, fatigue; abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).


Formerly known under the brand name Intermezzo.

How Supplied:

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