Zaleplon (Oral route)
Uses of This Medicine:
Zaleplon belongs to the group of medicines called central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Zaleplon is used to treat insomnia (trouble sleeping). In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Sleep medicines may cause a special type of memory loss or "amnesia". When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zaleplon only when you are able to get at least 4 hours of sleep before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of zaleplon in the pediatric population. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of zaleplon in the elderly. However, confusion and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem. Elderly patients may require a lower dose to help reduce unwanted effects .
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Sodium Oxybate
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Eslicarbazepine Acetate
- Morphine Sulfate Liposome
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse (or history of) or
- Drug abuse or dependence (or history of)— Dependence on zaleplon may develop.
- Breathing problems or
- Mental depression—Zaleplon may make the condition worse.
- Liver disease— Higher blood levels of zaleplon may result, increasing the chance of side effects.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).
Take zaleplon just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.
Do not take this medicine when your schedule does not permit you to get at least 4 hours of sleep.If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.
Zaleplon may be taken with or without food or on a full or empty stomach. However, taking this medicine with or immediately after a heavy or a high fat meal may make zaleplon not work as fast.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions .
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For the treatment of insomnia (trouble in sleeping):
- Adults—10 milligrams (mg) once a day at bedtime
- Older adults—5 mg once a day at bedtime
- Children up to 18 years of age—Use and dose must be determined by doctor.
- For the treatment of insomnia (trouble in sleeping):
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .
If you think you need to take zaleplon for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds: sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zaleplon is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to zaleplon before you drive, use machines, or do anything else that could be dangerous if you are dizzy, unsteady, or are not alert or able to see well.
If you develop any unusual and strange thoughts or behavior while taking zaleplon, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, hallucinations (seeing, hearing, smelling, or feeling things that are not there), and unusual excitement, nervousness, or irritability.
This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away .
If you will be taking zaleplon for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.
After taking zaleplon for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zaleplon or taking alcohol or other CNS depressants with zaleplon may lead to breathing problems and unconsciousness. Some signs of an overdose are clumsiness or unsteadiness, confusion, severe drowsiness, low blood pressure, unusual dullness or feeling sluggish, and troubled breathing.
Zaleplon may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine .
Side Effects of This Medicine:
- Less common
- blurred or double vision
- not feeling like oneself
- seeing, hearing, smelling, or feeling things that are not there
- Symptoms of overdose
- clumsiness or unsteadiness, severe
- dizziness or fainting
- drowsiness, severe
- weak muscle tone
- troubled breathing
- unusual dullness or feeling sluggish
- More common
- muscle pain
- Less common
- Abdominal pain
- burning, prickling, or tingling sensation
- difficulty concentrating
- dryness of mouth
- excess muscle tone
- eye pain
- heartburn, indigestion, or acid stomach
- itching or burning eyes
- joint stiffness and/or pain
- memory loss
- menstrual pain
- mental depression
- sensitive hearing
- severe headache
- shortness of breath
- skin rash
- tightness in chest
- trembling or shaking
- troubled breathing
- unusual weakness or tiredness
- Abdominal and muscle cramps
- convulsions (seizures)
- increased sweating
- trembling or shaking
Along with its needed effects, a medicine 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:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects 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:
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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014