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Zolpidem

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Overview

What is Zolpidem?

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: low substituted hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. The 5-mg tablet also contains black iron oxide & red iron oxide.



What does Zolpidem look like?



What are the available doses of Zolpidem?

5 mg and 10 mg tablets. Tablets scored ()

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

How should I use Zolpidem?

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 clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

The dose of zolpidem tartrate tablets should be individualized.


What interacts with Zolpidem?

Sorry No Records found


What are the warnings of Zolpidem?

Sorry No Records found


What are the precautions of Zolpidem?

Sorry No Records found


What are the side effects of Zolpidem?

Sorry No records found


What should I look out for while using Zolpidem?

Zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ()].


What might happen if I take too much Zolpidem?


How should I store and handle Zolpidem?

Store the oral suspension between 20°-25°C (68°-77°F). [See USP]. Dispense in a tight container. Protect from heat.Zolpidem tartrate 5 mg and 10 mg tablets are supplied in bottles of 100 and bottles of 500.Zolpidem tartrate tablets 5 mg are oval-shaped, brick red, film coated, 10 x 4.5 mm tablets, imprinted with W62 on one side. The 10 mg tablets are oval-shaped, white, film coated, 10 x 4.5 mm tablets, imprinted with W63 on one side. Tablets are scored.Store at controlled room temperature 20°-25° C (68°-77°F).Zolpidem tartrate 5 mg and 10 mg tablets are supplied in bottles of 100 and bottles of 500.Zolpidem tartrate tablets 5 mg are oval-shaped, brick red, film coated, 10 x 4.5 mm tablets, imprinted with W62 on one side. The 10 mg tablets are oval-shaped, white, film coated, 10 x 4.5 mm tablets, imprinted with W63 on one side. Tablets are scored.Store at controlled room temperature 20°-25° C (68°-77°F).Zolpidem tartrate 5 mg and 10 mg tablets are supplied in bottles of 100 and bottles of 500.Zolpidem tartrate tablets 5 mg are oval-shaped, brick red, film coated, 10 x 4.5 mm tablets, imprinted with W62 on one side. The 10 mg tablets are oval-shaped, white, film coated, 10 x 4.5 mm tablets, imprinted with W63 on one side. Tablets are scored.Store at controlled room temperature 20°-25° C (68°-77°F).


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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 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 α/α 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 tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ()].

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.

The following serious adverse reactions 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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Tips

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Interactions

Interactions

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