ZALEPLON (Page 4 of 5)

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 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 adaption 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

Two studies assessed the abuse liability of Zaleplon at doses of 25 mg, 50 mg, and 75 mg in subjects with known histories of sedative drug abuse. The results of these studies indicate that Zaleplon has an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics.

Dependence

The potential for developing physical dependence on Zaleplon and a subsequent withdrawal syndrome was assessed in controlled studies of 14-, 28-, and 35-night durations and in open-label studies of 6- and 12-month durations by examining for the emergence of rebound insomnia following drug discontinuation. Some patients (mostly those treated with 20 mg) experienced a mild rebound insomnia on the first night following withdrawal that appeared to be resolved by the second night. The use of the Benzodiazepine Withdrawal Symptom Questionnaire and examination of any other withdrawal-emergent events did not detect any other evidence for a withdrawal syndrome following abrupt discontinuation of Zaleplon therapy in pre-marketing studies.

However, available data cannot provide a reliable estimate of the incidence of dependence during treatment at recommended doses of Zaleplon. Other sedative/hypnotics have been associated with various signs and symptoms following abrupt discontinuation, ranging from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. Seizures have been observed in two patients, one of which had a prior seizure, in clinical trials with Zaleplon. Seizures and death have been seen following the withdrawal of zaleplon from animals at doses many times higher than those proposed for human use. Because individuals with a history of addiction to, or abuse of, drugs or alcohol are at risk of habituation and dependence, they should be under careful surveillance when receiving Zaleplon or any other hypnotic.

Tolerance

Possible tolerance to the hypnotic effects of Zaleplon 10 mg and 20 mg was assessed by evaluating time to sleep onset for Zaleplon compared with placebo in two 28-night placebo-controlled studies and latency to persistent sleep in one 35-night placebo-controlled study where tolerance was evaluated on nights 29 and 30. No development of tolerance to Zaleplon was observed for time to sleep onset over 4 weeks.

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 usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death.

Loss of consciousness, in addition to signs and symptoms consistent with CNS depressants as described above, have been reported following zaleplon overdose. Individuals have fully recovered from zaleplon overdoses of greater than 200 mg (10 times the maximum recommended dose of zaleplon). Rare instances of fatal outcomes following overdose with zaleplon, most often associated with overdose of additional CNS depressants, have been reported.

Recommended Treatment

General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Animal studies suggest that flumazenil is an antagonist to zaleplon. However, there is no pre-marketing clinical experience with the use of flumazenil as an antidote to a Zaleplon overdose. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.

Poison Control Center

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 risk of certain adverse events associated with the use of Zaleplon 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 should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).

Special Populations

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.

Hepatic insufficiency: Patients with mild to moderate hepatic 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.

PRECAUTIONS
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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 axis.

Bottles of 30’s: NDC 67877-210-30

Bottles of 100’s: NDC 67877-210-01

Bottles of 500’s: NDC 67877-210-05

Zaleplon capsules 10 mg are available as hard gelatin capsules with dark blue cap and dark blue body imprinted with “ASC” on cap and “211” on the body in black ink along the horizontal axis.

Bottles of 100’s: NDC 67877-211-01

Bottles of 500’s: NDC 67877-211-05

Bottles of 1000’s: NDC 67877-211-10

STORAGE CONDITIONS

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [see USP].

Dispense in a light-resistant container as defined in the USP.

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne,

Bardez, Goa 403 511, India

Marketed by:

Ascend Laboratories, LLC

MEDICATION GUIDE

Zaleplon Capsules C-IV

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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. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Zaleplon.

Reported activities include:

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

Important:

  1. Take Zaleplon exactly as prescribed
    • Do not take more Zaleplon than prescribed.
    • Take Zaleplon right before you get in bed, not sooner.
  2. 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
  3. Call your doctor right away if you find out that you have done any of the above activities after taking Zaleplon.

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What is Zaleplon?

Zaleplon is a sedative-hypnotic (sleep) medicine. Zaleplon is used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon does not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.

Zaleplon is not for children.

Zaleplon is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Zaleplon in a safe place to prevent misuse and abuse. Selling or giving away Zaleplon may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Zaleplon?

Do not take Zaleplon if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in 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 to10 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 (20° to 25°C) [see USP].
  • 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.

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

What are the ingredients in ZALEPLON?

Active Ingredient: zaleplon

Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40 and black iron oxide. Zaleplon 5mg capsules also contain FD&C yellow #5.

  • Zaleplon 5 mg –A hard gelatin capsule with light blue cap and light blue body imprinted with “ASC” on cap and “210” on the body in black ink along the horizontal axis.
  • Zaleplon 10 mg — A hard gelatin capsule with dark blue cap and dark blue body imprinted with “ASC” on cap and “211” on the body in black ink along the horizontal axis.

Rx only

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne,

Bardez, Goa 403 511, India

Marketed by:

Ascend Laboratories, LLC

Montvale, NJ 07645

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