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ZOLPIDEM TARTRATE

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Overview

What is ZOLPIDEM TARTRATE?

Zolpidem tartrate is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:

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 zolpidem tartrate tablet includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.



What does ZOLPIDEM TARTRATE look like?



What are the available doses of ZOLPIDEM TARTRATE?

Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Tablets are scored.

Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side.

Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side.

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

How should I use ZOLPIDEM TARTRATE?

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. ()

The dose of zolpidem tartrate tablets should be individualized.


What interacts with ZOLPIDEM TARTRATE?

Sorry No Records found


What are the warnings of ZOLPIDEM TARTRATE?

Sorry No Records found


What are the precautions of ZOLPIDEM TARTRATE?

Sorry No Records found


What are the side effects of ZOLPIDEM TARTRATE?

Sorry No records found


What should I look out for while using ZOLPIDEM TARTRATE?

Known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation ()


What might happen if I take too much ZOLPIDEM TARTRATE?


How should I store and handle ZOLPIDEM TARTRATE?

Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:NDC NumberSize21695-506-07                                                                              bottle of 721695-506-15                                                                              bottle of 1521695-506-30                                                                              bottle of 3021695-506-60                                                                              bottle of 60Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:NDC NumberSize21695-507-07                                                                             bottle of 721695-507-10                                                                              bottle of 1021695-507-15                                                                              bottle of 1521695-507-30                                                                              bottle of 3021695-507-60                                                                              bottle of 60Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Subunit modulation of the GABA receptor chloride channel macromolecular complex is hypothesized to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties. The major modulatory site of the GABA receptor complex is located on its alpha (α) subunit and is referred to as the benzodiazepine (BZ) or omega (ω) receptor. At least three subtypes of the (ω) receptor have been identified.

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs with known hypnotic properties, it interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem binds the (BZ) receptor preferentially with a high affinity ratio of the alpha/alpha subunits. The (BZ) receptor is found primarily on the Lamina IV of the sensorimotor cortical regions, substantia nigra (pars reticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. 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
Known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation ()

In vitro

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.

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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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