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Zolpidem tartrate sublingual

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Overview

What is Zolpidem tartrate sublingual?

Zolpidem tartrate sublingual tablets contain zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Zolpidem tartrate sublingual tablets are intended to be placed under the tongue where they will disintegrate.

Chemically, zolpidem tartrate is -6-trimethyl-2--tolylimidazo[1,2-]pyridine-3-acetamide L-(+)-tartrate (2:1).

Zolpidem tartrate is a white to off-white crystalline powder that is slightly soluble in water and sparingly soluble in alcohol. It has a molecular weight of 764.88.

Each zolpidem tartrate sublingual tablets include the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, pregelatinized corn starch, mannitol, peppermint flavor, saccharin sodium and corn starch.



What does Zolpidem tartrate sublingual look like?



What are the available doses of Zolpidem tartrate sublingual?

1.75 mg and 3.5 mg sublingual tablets (3)

What should I talk to my health care provider before I take Zolpidem tartrate sublingual?

How should I use Zolpidem tartrate sublingual?

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:

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[see Warnings and Precautions (5.1)].

Zolpidem tartrate sublingual tablets should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Zolpidem Tartrate Sublingual Tablets 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 Zolpidem tartrate sublingual?

Sorry No Records found


What are the warnings of Zolpidem tartrate sublingual?

Sorry No Records found


What are the precautions of Zolpidem tartrate sublingual?

Sorry No Records found


What are the side effects of Zolpidem tartrate sublingual?

Sorry No records found


What should I look out for while using Zolpidem tartrate sublingual?

Zolpidem tartrate 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 Zolpidem tartrate sublingual?


How should I store and handle Zolpidem tartrate sublingual?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Each sublingual tablet is individually packaged in a unit-dose pouch.  Zolpidem tartrate sublingual tablets 1.75 mg are white, round tablets, flat-faced, bevel-edged with debossed “NT” on one side and “124” on the other side and supplied as:Zolpidem tartrate sublingual tablets 3.5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P” & “350” on one side and plain on the other side and supplied as:Storage and Handling Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture. The patient should be instructed not to remove the sublingual tablet from the unit-dose pouch until the patient is ready to consume it.Each sublingual tablet is individually packaged in a unit-dose pouch.  Zolpidem tartrate sublingual tablets 1.75 mg are white, round tablets, flat-faced, bevel-edged with debossed “NT” on one side and “124” on the other side and supplied as:Zolpidem tartrate sublingual tablets 3.5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P” & “350” on one side and plain on the other side and supplied as:Storage and Handling Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture. The patient should be instructed not to remove the sublingual tablet from the unit-dose pouch until the patient is ready to consume it.Each sublingual tablet is individually packaged in a unit-dose pouch.  Zolpidem tartrate sublingual tablets 1.75 mg are white, round tablets, flat-faced, bevel-edged with debossed “NT” on one side and “124” on the other side and supplied as:Zolpidem tartrate sublingual tablets 3.5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P” & “350” on one side and plain on the other side and supplied as:Storage and Handling Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture. The patient should be instructed not to remove the sublingual tablet from the unit-dose pouch until the patient is ready to consume it.Each sublingual tablet is individually packaged in a unit-dose pouch.  Zolpidem tartrate sublingual tablets 1.75 mg are white, round tablets, flat-faced, bevel-edged with debossed “NT” on one side and “124” on the other side and supplied as:Zolpidem tartrate sublingual tablets 3.5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P” & “350” on one side and plain on the other side and supplied as:Storage and Handling Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture. The patient should be instructed not to remove the sublingual tablet from the unit-dose pouch until the patient is ready to consume it.Each sublingual tablet is individually packaged in a unit-dose pouch.  Zolpidem tartrate sublingual tablets 1.75 mg are white, round tablets, flat-faced, bevel-edged with debossed “NT” on one side and “124” on the other side and supplied as:Zolpidem tartrate sublingual tablets 3.5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P” & “350” on one side and plain on the other side and supplied as:Storage and Handling Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture. The patient should be instructed not to remove the sublingual tablet from the unit-dose pouch until the patient is ready to consume it.


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

Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.

Zolpidem tartrate, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of zolpidem tartrate and of other concomitant CNS depressants may be necessary when zolpidem tartrate is administered with such agents because of the potentially additive effects. The use of zolpidem tartrate 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 zolpidem tartrate 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 zolpidem tartrate is taken with less than 4 hours of bedtime remaining, if higher than recommended dose is taken, if coadministered with other CNS depressants, or coadministered 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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