Zaleplon (Zaleplon)

Trade Name : Zaleplon

West-Ward Pharmaceuticals Corp.

CAPSULE

Strength 5 mg/1

ZALEPLON gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zaleplon (Zaleplon) which is also known as Zaleplon and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 5 mg/1 per ml. Read more

Zaleplon (Zaleplon) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior .

Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its molecular formula is CHNO, and its molecular weight is 305.34. The structural formula is shown below.
Zaleplon USP is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7.
Zaleplon Capsules USP are available for oral administration containing either 5 mg or 10 mg of zaleplon. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each capsule shell contains: D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6 (10 mg capsule shell only), gelatin, monogramming ink and titanium dioxide. The monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.

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Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies under n . It has not been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.

Zalepon is contraindicated in patients:

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The premarketing development program for zaleplon included zaleplon exposures in patients and/or normal subjects from 2 different groups of studies: approximately 900 normal subjects in clinical pharmacology/pharmacokinetic studies; and approximately 2,900 exposures from patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 450 patient exposure years. The conditions and duration of treatment with zaleplon varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, COSTART terminology has been used to classify reported adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

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Signs and Symptoms
Signs and symptoms of overdose effects of CNS depressants can be expected to present as exaggerations of the pharmacological effects noted in preclinical testing. Overdose is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death.
Loss of consciousness, in addition to signs and symptoms consistent with CNS depressants as described above, have been reported following zaleplon overdose. Individuals have fully recovered from zaleplon overdoses of greater than 200 mg (10 times the maximum recommended dose of zaleplon). Rare instances of fatal outcomes following overdose with zaleplon, most often associated with overdose of additional CNS depressants, have been reported.
Recommended Treatment
General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Animal studies suggest that flumazenil is an antagonist to zaleplon. However, there is no premarketing clinical experience with the use of flumazenil as an antidote to a zaleplon overdose. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.
Poison Control Center
As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

The dose of zaleplon should be individualized. The recommended dose of zaleplon for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep n Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see under ).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic Insufficiency:
Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal Insufficiency:
No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population n

Zaleplon Capsules USP
5 mg capsule is supplied as a light green opaque capsule with u201c54 656u201d printed in black ink on cap and body, containing a white to an off-white powder.
NDC 0054-0084-25: Bottle of 100 Capsules
10 mg capsule is supplied as a green opaque capsule with u201c54 888u201d printed in black ink on cap and body, containing a white to an off-white powder.
NDC 0054-0085-25: Bottle of 100 Capsules
STORAGE CONDITIONS
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005659/08
Revised August 2019

Zaleplon Capsules USP CIV
(zalu2019 e plon)
Rx Only
Read this Medication Guide before you start taking zaleplon and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. You and your doctor should talk about zaleplon when you start taking it and at regular checkups.
What is the most important information I should know about zaleplon?
Zaleplon may cause serious side effects including complex sleep behaviors that may cause serious injury and death.
Reported activities include:
Important:
1. Take zaleplon exactly as prescribed
2. Do not take zaleplon if you:
3. Stop taking zaleplon and call your doctor right away if you find out that you have done any of the above activities after taking zaleplon.
What is zaleplon?
Zaleplon is a sedative/hypnotic (sleep) medicine. Zaleplon is used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon does not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.
Zaleplon is not for children.
Who should not take zaleplon?
Do not take zaleplon if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in zaleplon.
Zaleplon may not be right for you. Before starting zaleplon, tell your doctor about all ofn- your health conditions, including if you:
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact, sometimes causing side effects. n
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take zaleplon?
What are the possible side effects of zaleplon?
Serious side effects of zaleplon include:
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zaleplon.
Common side effects of zaleplon include:
These are not all the side effects of zaleplon. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store zaleplon?
General Information about zaleplon
This Medication Guide summarizes the most important information about zaleplon. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zaleplon that was written for healthcare professionals.
If you would like more information, please call West-Ward Pharmaceuticals Corp. at 1-800-962-8364.
What are the ingredients in Zaleplon Capsules USP?
Active Ingredient:
Inactive Ingredients:
This Medication Guide had been approved by the U.S. Food and Drug Administration.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005659/08
Revised August 2019

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Zaleplon (Zaleplon)

Trade Name : Zaleplon

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Zaleplon (Zaleplon)

Trade Name : Zaleplon

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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