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ZALEPLON

Physicians Total Care, Inc.

Zaleplon Capsules CIV


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ZALEPLON DESCRIPTION


17155
ZALEPLON


CLINICAL PHARMACOLOGY

Pharmacodynamics and Mechanism of Action




AA112212

Pharmacokinetics


max1/2

Absorption


Distribution


in vitro

Metabolism


Elimination


½

Effect of Food


maxmax

Special Populations


Age



Gender




Race


max

Hepatic impairment


max DOSAGE AND ADMINISTRATION

Renal impairment


Drug-Drug Interactions


Drug Interactions PRECAUTIONS.

Clinical Trials

Controlled Trials Supporting Effectiveness




Transient Insomnia



Chronic Insomnia














Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs


Memory Impairment

ADVERSE REACTIONS

Sedative/Psychomotor Effects


ADVERSE REACTIONS

Withdrawal-Emergent Anxiety and Insomnia








Other Withdrawal-Emergent Phenomena


ZALEPLON INDICATIONS AND USAGE


Clinical Trials CLINICAL PHARMACOLOGY

ZALEPLON CONTRAINDICATIONS


PRECAUTIONS

WARNINGS


The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. DOSAGE AND ADMINISTRATION

Abnormal Thinking and Behavioral Changes






DRUG ABUSE AND DEPENDENCE

Because of the rapid onset of action, zaleplon should only be ingested immediately prior to going to bed or after the patient has gone to bed and has experienced difficulty falling asleep

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


DOSAGE AND ADMINISTRATION

Use in patients with concomitant illness






DOSAGE AND ADMINISTRATION

Use in patients with depression


OVERDOSAGE

Information for Patients




SPECIAL CONCERNS “Sleep-Driving” and other complex behaviors


WARNINGS

Laboratory Tests


Drug Interactions


CNS-Active Drugs


Ethanol



Imipramine



Paroxetine



Thioridazine



Venlafaxine



Promethazine

Drugs That Induce CYP3A4


Rifampin

max

Drugs That Inhibit CYP3A4


in vitro

Drugs That Inhibit Aldehyde Oxidase




Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4


in vitroin vitroin vivomax DOSAGE AND ADMINISTRATION

Drugs Highly Bound to Plasma Protein


Drugs with a Narrow Therapeutic Index




Drugs That Alter Renal Excretion


Carcinogenesis, Mutagenesis, Impairment of Fertility


Carcinogenesis


2 2

Mutagenesis


in vitroin vitroin vitro in vivo

Impairment of Fertility


2

Pregnancy




2 2

2 in utero

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





  Table 1  Incidence (%) of Treatment-Emergent Adverse Events in Long-Term (28 and 35 Nights) Placebo-Controlled Clinical Trials of Zaleplon1
   Body System
      Preferred Term
Placebo

(n = 344)
Zaleplon
5 mg or 10 mg
(n = 569)
Zaleplon
20 mg
(n = 297)
1: Events for which the incidence for zaleplon 20 mg-treated patients was at least 1% and greater than the incidence among placebo-treated patients. Incidence greater than 1% has been rounded to the nearest whole number.
   Body as a whole
 
 
 
      Abdominal pain
3
6
6
      Asthenia
5
5
7
      Headache
35
30
42
      Malaise
<1
<1
2
      Photosensitivity reaction
<1
<1
1
   Digestive system
      Anorexia
<1
<1
2
      Colitis
0
0
1
      Nausea
7
6
8
   Metabolic and nutritional
      Peripheral edema
<1
<1
1
   Nervous system
 
 
 
      Amnesia
1
2
4
      Confusion
<1
<1
1
      Depersonalization
<1
<1
2
      Dizziness
7
7
9
      Hallucinations
<1
<1
1
      Hypertonia
<1
1
1
      Hypesthesia
<1
<1
2
      Paresthesia
1
3
3
      Somnolence
4
5
6
      Tremor
1
2
2
      Vertigo
<1
<1
1
   Respiratory system
      Epistaxis
<1
<1
1
   Special senses
      Abnormal vision
<1
<1
2
      Ear pain
0
<1
1
      Eye pain
2
4
3
      Hyperacusis
<1
1
2
      Parosmia
<1
<1
2
   Urogenital system
      Dysmenorrhea
2
3
4

Other Adverse Events Observed During the Premarketing Evaluation of Zaleplon


ADVERSE REACTIONS


frequentinfrequentrare

Body as a whole
Frequent:Infrequent:

Cardiovascular system
Frequent:Infrequent:Rare:

Digestive system
Frequent:Infrequent:Rare:

Endocrine system
Rare:

Hemic and lymphatic system
Infrequent: Rare:

Metabolic and nutritional
Infrequent: Rare:

Musculoskeletal system
Frequent: Infrequent:Rare:

Nervous system
Frequent: Infrequent:Rare:

Respiratory system
Frequent:Infrequent:Rare:

Skin and appendages
Frequent:Infrequent:Rare:

Special senses
Frequent:Infrequent: Rare:

Urogenital system
Infrequent:Rare: 

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




PRECAUTIONS Pharmacokinetics CLINICAL PHARMACOLOGY

Special Populations


Hepatic insufficiency


Renal insufficiency




Drug Interactions PRECAUTIONS

HOW SUPPLIED


Zaleplon Capsules, 5 mg





Zaleplon Capsules, 10 mg





Store at




Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited





Relabeling and Repackaging by:


MEDICATION GUIDE


Zaleplon Capsules CIV
Rx only


__________________________________________________________________________________________
What is the most important information I should know about zaleplon?


After taking zaleplon, 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.

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

Important:
  • 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.


What is zaleplon?




Who should not take zaleplon?




Zaleplon
may not be right for you. Before starting zaleplon, tell your doctor about all of your health conditions, including if you:
  • 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.  


How should I take zaleplon?
  • 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.

What are the possible side effects of zaleplon?

Serious side effects of zaleplon
include:
  • 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.


Common side effects of zaleplon include:
  • 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.


How should I store zaleplon?
  • 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.

General Information about zaleplon
  • 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


Inactive Ingredients:
  • 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





Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg



Zaleplon Capsules

10 mg CIV


PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY


Rx only               



ZALEPLON

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg



Zaleplon Capsules

5 mg CIV  

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY

Rx only 


ZALEPLON

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


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Be sure to consult your doctor before taking any medication!
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