Zaleplon (Zaleplon)

Trade Name : Zaleplon

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 5 mg/1

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

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Teva Pharmaceuticals USA, Inc.. 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Zaleplon, USP is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is -[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]--ethylacetamide. The structural formula is shown below.
  • CHNO M.W. 305.34
  • 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 contain zaleplon, USP as the active ingredient, and has the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40 aluminum lake, gelatin, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide. In addition, the 10 mg capsule contains FD&C blue #1.
  • No data
  • Zaleplon Capsules are indicated for the short-term treatment of insomnia. Zaleplon Capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see , ). They have 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.
  • Hypersensitivity to zaleplon or any excipients in the formulation (see also ).
  • 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 zaleplon. Because some of the important adverse effects of zaleplon appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly (see ).
  • A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization.
  • No data
  • 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.
  • No data
  • No data
  • The dose of zaleplon capsules should be individualized. The recommended dose of zaleplon capsules 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 capsules 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 capsules should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see ). Taking zaleplon capsules with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon capsules on sleep latency (see ,).
  • Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon capsules. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
  • Zaleplon Capsules, USP are available as:
  • 5 mg - an opaque white body and opaque blue green cap, imprinted with u201c93u201d over u201c5268u201d on both the cap and the body in bottles of 100 (NDC 0093-5268-01).
  • 10 mg - an opaque aqua blue body and opaque blue green cap, imprinted with u201c93u201d over u201c5269u201d on both the cap and the body in bottles of 100 (NDC 0093-5269-01).
  • 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, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA
  • PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. G 8/2015
  • ZALEPLON (ZAL-e-plon) CAPSULES USP
  • CIV
  • Read this Medication Guide before you start taking zaleplon capsules 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 capsules when you start taking them and at regular checkups.
  • What is the most important information I should know about zaleplon capsules?
  • After taking zaleplon capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.
  • Important:
  • 1. Take zaleplon capsules exactly as prescribed
  • 2. Do not take zaleplon capsules if you:
  • 3. Call your doctor right away if you find out that you have done any of the above activities after taking zaleplon capsules.
  • What are zaleplon capsules?
  • Zaleplon capsules are a sedative-hypnotic (sleep) medicine. Zaleplon capsules are used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon capsules do not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.
  • Zaleplon capsules are not for children.
  • Who should not take zaleplon capsules?
  • Do not take zaleplon capsules if you are allergic to anything in them. See the end of this Medication Guide for a complete list of ingredients in zaleplon capsules.
  • Zaleplon capsules may not be right for you. Before starting zaleplon capsules, tell your doctor about all of 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 capsules?
  • What are the possible side effects of zaleplon capsules?
  • Serious side effects of zaleplon capsules 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 capsules.
  • Common side effects of zaleplon capsules include:
  • These are not all the side effects of zaleplon capsules. 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 capsules?
  • General Information about zaleplon capsules
  • This Medication Guide summarizes the most important information about zaleplon capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zaleplon capsules that was written for healthcare professionals.
  • If you would like more information, call 1-888-838-2872.
  • What are the ingredients in zaleplon capsules USP?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVAn- PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. E 8/2015
  • No data
  • No data

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.