Zaleplon

Name: Zaleplon

Zaleplon Overview

Zaleplon is a prescription medication used to treat insomnia.

Zaleplon belongs to a group of drugs called sedatives or hypnotics. It works by slowing activity in the brain to allow sleep.

This medication comes in capsule form. It is taken immediately before bedtime with a full glass of water.

Common side effects of Zaleplon are drowsiness, lightheadedness, and dizziness.

Zaleplon Brand Names

Zaleplon may be found in some form under the following brand names:

  • Sonata

Inform MD

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. 

Zaleplon Dosage

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. Doses above 20 mg have not been adequately evaluated and are not recommended.

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.

Patients with mild to moderate hepatic (liver) 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.

An starting dose of 5 mg should be given to patients taking cimetidine because zaleplon clearance is reduced in this population.

 

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

To make sure zaleplon is safe for you, tell your doctor if you have ever been addicted to drugs or alcohol.

Zaleplon may be habit-forming. Keep the medication in a place where others cannot get to it. MISUSE OF THIS MEDICATION CAN CAUSE ADDICTION OR OVERDOSE, especially in a child or other person using the medicine without a prescription. Selling or giving away zaleplon is against the law.

How should I take zaleplon?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens, stop taking zaleplon and talk with your doctor about another treatment for your sleep disorder.

Avoid taking zaleplon within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Zaleplon is for short-term use only. Do not take zaleplon for longer than 2 weeks without your doctor's advice.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using zaleplon for 7 to 10 nights in a row

Zaleplon may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF THIS MEDICATION CAN CAUSE ADDICTION OR OVERDOSE, especially in a child or other person using the medicine without a prescription. Selling or giving away zaleplon is against the law.

Do not stop using zaleplon suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Zaleplon is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What should I avoid while taking zaleplon?

Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not drink alcohol. Dangerous side effects could occur.

Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

Avoid taking zaleplon during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get at least 4 hours of sleep after taking zaleplon.

What other drugs will affect zaleplon?

Taking zaleplon with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Cautions for Zaleplon

Contraindications

  • Hypersensitivity to zaleplon or any ingredient in the formulation.a

Warnings/Precautions

Warnings

Adequate Patient Evaluation

Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.1

Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition.1

Adverse Psychiatric Events

Abnormal thinking and behavioral changes (e.g. aggressiveness, uncharacteristic extroversion, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur unpredictably.1 Immediately evaluate any new behavioral sign or symptom.1

Complex Sleep-related Behaviors

Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food, while asleep.25

Withdrawal Effects

Rapid dosage reduction or abrupt discontinuance of sedatives or hypnotics has resulted in signs or symptoms of withdrawal.1

Rebound insomnia (1 day in duration) observed, principally in patients receiving 20-mg dose.1 At least 2 cases of seizure (1 with seizure history) reported.1

Abuse Potential

Abuse potential of high doses (2.5–7.5 times recommended hypnotic dose) similar to that of benzodiazepines and related hypnotics.1 4 10 12 20

Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.1

CNS Effects

Rapid onset of CNS effects (short-term memory impairment, hallucinations, impaired coordination, dizziness, lightheadedness); administer only immediately before going to bed or after unsuccessfully attempting to sleep.1

Peformance of activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) may be impaired the day after ingestion.1

Concurrent use of other CNS depressants may cause additive or potentiated CNS depression.1 (See Specific Drugs under Interactions.)

Sensitivity Reactions

Potential risk of anaphylaxis and angioedema; may occur as early as the first dose of the drug.25

Tartrazine

Preparations contain tartrazine (FD&C; yellow No. 5).1 Tartrazine may cause allergic reactions including bronchial asthma in susceptible individuals.1 Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.1

General Precautions

Respiratory Effects

Possible depressed respiration with sedative-hypnotics.1 No respiratory depressant effects reported at hypnotic doses of zaleplon in healthy individuals or in patients with mild to moderate COPD or moderate obstructive sleep apnea.1

Caution is advised in patients with impaired respiratory function.1

Concomitant Disease

Limited experience in patients with concomitant systemic disease.1 Use with caution in patients with diseases affecting metabolism or hemodynamic response.1

Suicide

Use with caution in depressed patients.1 Potential for suicidal tendencies; overdosage more frequent in such patients.1 Prescribe and dispense drug in the smallest feasible quantity.1 Do not prescribe more than 30-day supply.a

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk.1 11 Use not recommended.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 20

Geriatric Use

Possibility exists of greater sensitivity to pharmacologic and adverse effects of sedatives and hypnotics in patients ≥65 years of age;1 reduce initial and maximum dose.1 19 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Reduce dosage for mild to moderate hepatic impairment.1 Use not recommended in patients with severe hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration.)

Debilitated Patients

Potential increased sensitivity to sedatives and hypnotics or impaired motor performance after repeated exposure.1 Reduce dosage and monitor closely.1 (See Debilitated or Low-weight Patients under Dosage and Administration.)

Common Adverse Effects

Headache, asthenia, dizziness, nausea, abdominal pain, somnolence.1

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 20–25°C.a

Commonly used brand name(s)

In the U.S.

  • Sonata

Available Dosage Forms:

  • Capsule

Therapeutic Class: Nonbarbiturate Hypnotic

What do I need to tell my doctor BEFORE I take Zaleplon?

  • If you have an allergy to zaleplon or any other part of zaleplon.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
  • If you are breast-feeding. Do not breast-feed while you take zaleplon.
  • If the patient is a child. Do not give this medicine to a child.

This is not a list of all drugs or health problems that interact with zaleplon.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Zaleplon) best taken?

Use zaleplon as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take this medicine either right before bedtime or after you have already gone to bed and are having trouble falling asleep.
  • Do not take with or right after a meal.
  • Do not take zaleplon unless you can get a full night's sleep (at least 7 to 8 hours) before you need to be active again.
  • If you still have trouble sleeping after 7 to 10 days, call your doctor.

What do I do if I miss a dose?

  • If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
  • If you will not be able to get a full night's sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Do not take more than 1 dose of zaleplon in the same day.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

Package label.principal display panel

NDC 16714-551-02

Rx only

Zaleplon Capsules, USP

CIV

5 mg

100 Capsules

NORTHSTARTM

NDC 16714-561-02

Rx only

Zaleplon Capsules, USP

CIV

10 mg

100 Capsules

NORTHSTARTM

Zaleplon 
Zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16714-551
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zaleplon (Zaleplon) Zaleplon 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
GELATIN  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 5  
Product Characteristics
Color GREEN (dark green) , blue (light blue) Score no score
Shape capsule Size 14mm
Flavor Imprint Code ZLP;2122
Contains     
Packaging
# Item Code Package Description
1 NDC:16714-551-02 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090374 06/23/2010
Zaleplon 
Zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16714-561
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zaleplon (Zaleplon) Zaleplon 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
GELATIN  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 5  
Product Characteristics
Color GREEN (dark green) , blue (opaque blue) Score no score
Shape capsule Size 14mm
Flavor Imprint Code ZLP;2130
Contains     
Packaging
# Item Code Package Description
1 NDC:16714-561-02 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090374 06/23/2010
Labeler - Northstar Rx LLC (830546433)
Registrant - Orchid Pharma Ltd (650133507)
Establishment
Name Address ID/FEI Operations
Orchid Healthcare (a division of Orchid Pharma Ltd) 650288850 analysis(16714-551, 16714-561), pack(16714-551, 16714-561), manufacture(16714-551, 16714-561), label(16714-551, 16714-561)
Revised: 09/2016   Northstar Rx LLC

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Sonata: 5 mg, 10 mg [contains tartrazine (fd&c yellow #5)]

Generic: 5 mg, 10 mg

Special Populations Race

Cmax and AUC were increased 37% and 64%, respectively in Asian populations.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

For the Consumer

Applies to zaleplon: oral capsule

Along with its needed effects, zaleplon may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zaleplon:

Less common
  • Anxiety
  • blurred or double vision
  • not feeling like oneself
Rare
  • Nosebleed
  • seeing, hearing, smelling, or feeling things that are not there

Get emergency help immediately if any of the following symptoms of overdose occur while taking zaleplon:

Symptoms of overdose
  • Confusion
  • clumsiness or unsteadiness, severe
  • dizziness or fainting
  • drowsiness, severe
  • weak muscle tone
  • troubled breathing
  • unusual dullness or feeling sluggish

Some side effects of zaleplon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dizziness
  • headache
  • muscle pain
  • nausea
Less common
  • Abdominal pain
  • burning, prickling, or tingling sensation
  • constipation
  • cough
  • difficulty concentrating
  • drowsiness
  • dryness of mouth
  • excess muscle tone
  • eye pain
  • fever
  • heartburn, indigestion, or acid stomach
  • itching
  • itching or burning eyes
  • joint stiffness and/or pain
  • memory loss
  • menstrual pain
  • mental depression
  • nervousness
  • sensitive hearing
  • severe headache
  • shortness of breath
  • skin rash
  • tightness in chest
  • trembling or shaking
  • troubled breathing
  • unusual weakness or tiredness
  • wheezing

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Abdominal and muscle cramps
  • convulsions (seizures)
  • increased sweating
  • sadness
  • trembling or shaking
  • vomiting

Dialysis

Data not available.

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