FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Intermezzo® (zolpidem tartrate) sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Limitations of Use: Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
History
There is currently no drug history available for this drug.
Other Information
Intermezzo contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Intermezzo is available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Intermezzo sublingual tablets are intended to be placed under the tongue where they will disintegrate.
Intermezzo sublingual tablets contain a bicarbonate-carbonate buffer.
Chemically, zolpidem tartrate is N,N-6-trimethyl-2-p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate (2:1).
Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.
Each Intermezzo tablet includes the following inactive ingredients: mannitol, sorbitol, crospovidone, silicon dioxide, sodium carbonate, sodium bicarbonate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide, natural and artificial spearmint flavor, silicon dioxide-colloidal, and sucralose. The 1.75 mg tablet also contains yellow iron oxide, and the 3.5 mg tablet contains beige iron oxide.
Sources
Intermezzo Manufacturers
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Purdue Pharma Lp
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