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Intermezzo

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Overview

What is Intermezzo?

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 ,-6-trimethyl-2--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.



What does Intermezzo look like?



What are the available doses of Intermezzo?

1.75 mg and 3.5 mg sublingual tablets

What should I talk to my health care provider before I take Intermezzo?

How should I use Intermezzo?

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 to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Intermezzo should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking .

Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Intermezzo should not be administered with or immediately after a meal. The tablet should be removed from the pouch just prior to dosing.


What interacts with Intermezzo?

Sorry No Records found


What are the warnings of Intermezzo?

Sorry No Records found


What are the precautions of Intermezzo?

Sorry No Records found


What are the side effects of Intermezzo?

Sorry No records found


What should I look out for while using Intermezzo?

Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema .


What might happen if I take too much Intermezzo?


How should I store and handle Intermezzo?

StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].Each sublingual tablet is individually packaged in a unit-dose pouch.Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCIntermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCEach sublingual tablet is individually packaged in a unit-dose pouch.Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCIntermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCEach sublingual tablet is individually packaged in a unit-dose pouch.Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCIntermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCEach sublingual tablet is individually packaged in a unit-dose pouch.Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCIntermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCEach sublingual tablet is individually packaged in a unit-dose pouch.Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDCIntermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:NDC


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which nonselectively bind to and activate all BZ receptor subtypes, zolpidem binds the BZ receptor preferentially with a high affinity ratio of the alpha/alpha subunits. This selective binding of zolpidem on the BZ receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.

Non-Clinical Toxicology
Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema .

Intermezzo, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Intermezzo and of other concomitant CNS depressants may be necessary when Intermezzo is administered with such agents because of the potentially additive effects. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended .

In a driving study, healthy subjects who received Intermezzo with fewer than four hours of bedtime remaining had evidence of impaired driving compared to subjects who received placebo . The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining, if higher than recommended dose is taken, if co-administered with other CNS depressants, or co-administered with other drugs that increase the blood levels of zolpidem.

The following serious adverse reactions in zolpidem-treated patients are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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