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Intermezzo sublingual

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Intermezzo sublingual Uses

This medication is used to treat a certain type of sleep problem (insomnia) in adults who have trouble falling back asleep after waking up in the middle of the night. It helps you return to sleep faster so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.

This medication should only be taken if you have at least 4 hours of bedtime left.

Zolpidem is usually limited to short treatment periods of 1 to 2 weeks or less.

How to use Intermezzo sublingual

Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start taking zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you wake up in the middle of the night and have trouble falling asleep again, take this medication as directed by your doctor, usually only once a night if needed. Only take it if you have at least 4 hours of bedtime left, otherwise you may still be drowsy in the morning.

Do not take this medication with alcohol, or if you have had alcohol that day, especially in the evening or before bed. Also do not take this medication with other drugs to help you sleep.

Do not remove the medication from the pouch until you are ready to take it. Since zolpidem works quickly, take it while you are in bed. It is best to take it on an empty stomach. Do not take zolpidem with or after a meal because it will not work as quickly. Place the tablet under your tongue and let it break apart completely before swallowing. Do not swallow the tablet whole.

The dosage is based on your gender, age, medical condition, response to treatment, and other medications you may be taking. Women are usually prescribed a lower dose because it is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects. Do not increase your dose, take it more often, or use it for longer than prescribed. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists after 7 to 10 days, or if it worsens.

You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1-2 nights. If this effect continues, contact your doctor.

Intermezzo sublingual Side Effects

Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

This medication may make you sleepy during the day, especially if you do not take it as instructed (see the How to Use section). Tell your doctor or pharmacist if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Intermezzo sublingual Precautions

Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, personal or family history of sleepwalking, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, wait at least 4 hours after taking a dose and until you feel completely awake before doing any activity. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Discuss the risks and benefits with your doctor.

A small amount of this medication passes into breast milk. Consult your doctor before breast-feeding.

Intermezzo sublingual Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: sodium oxybate.

Other medications can affect the removal of zolpidem from your body, which may affect how zolpidem works. Examples include rifampin, among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, other medicine for sleep or anxiety (such as alprazolam, diazepam, lorazepam), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Intermezzo sublingual Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slowed breathing or a deep sleep from which you cannot be awakened.

NOTES:

Do not share this medication with others. It is against the law.

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

MISSED DOSE:

Not applicable.

STORAGE:

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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