Label: ZALEPLON capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2010

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  • DESCRIPTION
    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 empirical ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics and Mechanism of Action - While Zaleplon is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties ...
  • INDICATIONS & USAGE
    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 (see Clinical ...
  • CONTRAINDICATIONS
    Hypersensitivity to zaleplon or any excipients in the formulation (see also PRECAUTIONS).
  • WARNINGS
    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 ...
  • PRECAUTIONS
    General Precautions - Timing of Drug Administration - Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep. As ...
  • ADVERSE REACTIONS
    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 ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance Class - Zaleplon is classified as a Schedule IV controlled substance by federal regulation. Abuse, Dependence, and Tolerance - Abuse and addiction are separate and distinct ...
  • OVERDOSAGE
    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 ...
  • DOSAGE & ADMINISTRATION
    The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the ...
  • HOW SUPPLIED
    Zaleplon capsules 5 mg are available as hard gelatin capsules with light blue cap and light blue body imprinted with "ASC" on cap and "210" on the body in black ink along the horizontal ...
  • MEDICATION GUIDE
    Zaleplon Capsules C-IV - 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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    ZALEPLON CAPSULES 5 mg - Container Label - NDC 67877-210-30 - ZALEPLONCIV - CAPSULES - 5mg - Pharmacist: dispense with Medication Guide - Rx Only - 30 Capsules - ZALEPLON CAPSULES 10 mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information