ZALEPLON

Physicians Total Care, Inc.

Zaleplon Capsules CIV

FULL PRESCRIBING INFORMATION: CONTENTS*

• ZALEPLON DESCRIPTION
• CLINICAL PHARMACOLOGY
  • Pharmacodynamics and Mechanism of Action
  • Pharmacokinetics
  • Drug-Drug Interactions
  • Clinical Trials
• ZALEPLON INDICATIONS AND USAGE
• ZALEPLON CONTRAINDICATIONS
• WARNINGS
  • Abnormal Thinking and Behavioral Changes
  • Severe anaphylactic and anaphylactoid reactions
• PRECAUTIONS
  • General
  • Information for Patients
  • Laboratory Tests
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• ZALEPLON ADVERSE REACTIONS
  • Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
  • Other Adverse Events Observed During the Premarketing Evaluation of Zaleplon
  • Postmarketing Reports
• DRUG ABUSE AND DEPENDENCE
  • Controlled Substance Class
• OVERDOSAGE
  • Signs and Symptoms
  • Recommended Treatment
  • Poison Control Center
• ZALEPLON DOSAGE AND ADMINISTRATION
  • Special Populations
• HOW SUPPLIED
• MEDICATION GUIDE
  • Who should not take zaleplon?
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg

FULL PRESCRIBING INFORMATION

ZALEPLON DESCRIPTION

CLINICAL PHARMACOLOGY

Pharmacodynamics and Mechanism of Action

Pharmacokinetics

Absorption

Distribution

Metabolism

Elimination

Effect of Food

Special Populations

Drug-Drug Interactions

Clinical Trials

Controlled Trials Supporting Effectiveness

Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs

ZALEPLON INDICATIONS AND USAGE

ZALEPLON CONTRAINDICATIONS

WARNINGS

Abnormal Thinking and Behavioral Changes

Severe anaphylactic and anaphylactoid reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the drug.

PRECAUTIONS

General

Timing of Drug Administration

Use in the elderly and/or debilitated patients

Use in patients with concomitant illness

Use in patients with depression

Information for Patients

SPECIAL CONCERNS “Sleep-Driving” and other complex behaviors

Laboratory Tests

Drug Interactions

CNS-Active Drugs

Drugs That Induce CYP3A4

Drugs That Inhibit CYP3A4

Drugs That Inhibit Aldehyde Oxidase

Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4

Drugs Highly Bound to Plasma Protein

Drugs with a Narrow Therapeutic Index

Drugs That Alter Renal Excretion

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Mutagenesis

Impairment of Fertility

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

ZALEPLON ADVERSE REACTIONS

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Adverse Events Associated With Discontinuation of Treatment

Adverse Events Occurring at an Incidence of 1% or More Among Zaleplon 20 mg-Treated Patients

Other Adverse Events Observed During the Premarketing Evaluation of Zaleplon

Postmarketing Reports

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class

Abuse, Dependence, and Tolerance

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances.

Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Abuse

Dependence

Tolerance

OVERDOSAGE

Signs and Symptoms

Recommended Treatment

Poison Control Center

ZALEPLON DOSAGE AND ADMINISTRATION

Special Populations

Hepatic insufficiency

Renal insufficiency

HOW SUPPLIED

MEDICATION GUIDE

• driving a car ("sleep-driving") 
• making and eating food
• talking on the phone 
• having sex
• sleep-walking

• Take zaleplon exactly as prescribed
  • Do not take more zaleplon than prescribed.
  • Take zaleplon right before you get in bed, not sooner.
• Do not take zaleplon if you:
  • drink alcohol
  • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zaleplon with your other medicines
  • cannot get a full night’s sleep
• Call your doctor right away if you find out that you have done any of the above activities after taking zaleplon.

Who should not take zaleplon?

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

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. Do not take zaleplon with other medicines that can make you sleepy.

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.  

• Take zaleplon exactly as prescribed. Do not take more zaleplon than prescribed for you.
• Take zaleplon right before you get into bed. Or you can take zaleplon after you have been in bed and have trouble falling asleep.
• Do not take zaleplon with or right after a meal.
• Do not take zaleplon unless you are able to get a full night’s sleep before you must be active again.
• Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much zaleplon or overdose, call your doctor or poison control center right away, or get emergency treatment.

• getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about zaleplon?)
• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking zaleplon.

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.

• drowsiness
• lightheadedness
• dizziness
• “pins and needles” feeling on your skin
• difficulty with coordination
• You may still feel drowsy the next day after taking zaleplon. Do not drive or do other dangerous activities after taking zaleplon until you feel fully awake.
• You may have withdrawal symptoms when you stop taking zaleplon. Withdrawal symptoms include unpleasant feelings, stomach and muscle cramps, vomiting, sweating, shakiness, and rarely seizures. You may also have more trouble sleeping the first few nights after zaleplon is stopped. The problem usually goes away on its own after 1 or 2 nights.

These are not all the side effects of zaleplon. Ask your doctor or pharmacist for more information.

• Store zaleplon at room temperature between 68° and 77°F (20º to 25ºC).
• Protect from light.
• Keep zaleplon and all medicines out of the reach of children.

• Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide.
• Do not use zaleplon for a condition for which it was not prescribed.
• Do not give zaleplon to other people, even if they have the same condition. It may harm them and it is against the law.

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, contact the Aurobindo Pharma USA, Inc. Professional Information Services at 1-866-850-2876.

What are the ingredients in zaleplon capsules?

Active Ingredient: zaleplon

• Zaleplon Capsules, 5 mg are Opaque green/opaque pale green colored, size ‘4’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘E19’ on opaque green cap and ‘5 mg’ on opaque pale green body with black ink.
• Zaleplon Capsules, 10 mg are Opaque green/opaque light green colored, size ‘4’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘E20’ on opaque green cap and ‘10 mg’ on opaque light green body with black ink.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg

Zaleplon Capsules

10 mg CIV

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY

Rx only               

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg

Zaleplon Capsules

5 mg CIV  

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY

Rx only 

ZALEPLON ZALEPLON CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:54868-5909(NDC:65862-214) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZALEPLON ZALEPLON 5 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline lactose monohydrate STARCH, CORN SODIUM LAURYL SULFATE SILICON DIOXIDE STEARIC ACID FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C YELLOW NO. 5 titanium dioxide GELATIN FERROSOFERRIC OXIDE SHELLAC Product Characteristics Color Size Imprint Code Shape GREEN (Opaque Green or Opaque Pale Green) 14 mm E19;5;mg CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5909-0 10 in 1 BOTTLE 2 NDC:54868-5909-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078829 2008-06-19

ZALEPLON ZALEPLON CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:54868-5908(NDC:65862-215) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZALEPLON ZALEPLON 10 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline lactose monohydrate STARCH, CORN SODIUM LAURYL SULFATE SILICON DIOXIDE STEARIC ACID FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C YELLOW NO. 5 titanium dioxide GELATIN FERROSOFERRIC OXIDE SHELLAC Product Characteristics Color Size Imprint Code Shape GREEN (Opaque Green or Opaque Light Green) 14 mm E20;10;mg CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5908-0 10 in 1 BOTTLE 2 NDC:54868-5908-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078829 2008-06-19