Zolpidem (Into the mouth)
Edluar, Intermezzo, ZolpimistThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:Do not use this medicine if you have had an allergic reaction to zolpidem.
How to Use This Medicine:
- Take your medicine as directed.
- This medicine is not for long-term use.
- This medicine is usually taken just before bedtime, or when you are having trouble falling asleep. You should not use this medicine if you are not able to sleep or rest for about 7 to 8 hours before you need to be active again. Do not take the Intermezzo® brand of medicine unless you have at least 4 hours to sleep or rest.
- This medicine should not be taken with food or right after a meal. It is best to take this medicine on an empty stomach.
- Oral spray:
- If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.
- To use: First, pull the child-resistant cap to separate it from the base. Remove the clear protective cap from the pump. Hold the container upright with the black spray opening pointed directly into your mouth. Fully press down on the pump to make sure that a full dose (5 mg) of this medicine is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given. Put the clear protective cap back over the pump after each use.
- Sublingual tablet:
- Do not use a tablet that is broken.
- Do not open the blister pack that contains the tablet until you are ready to take your medicine. Do not use the tablet if the seal of the blister pack is broken.
- Remove the tablet from the blister pack by peeling back the top layer of paper, then push the tablet through the foil.
- Place the tablet under your tongue. Let it dissolve completely in your mouth. Do not swallow the tablet whole. Do not take with water.
- This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
If a dose is missed:
- Use this medicine only when you cannot sleep. You do not need to keep a schedule for taking it.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the oral spray in an upright position.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed. Throw away the child-resistant container of the oral spray when the 60 sprays have been used.
- Keep all medicine out of the reach of children. Never share your medicine with anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you also use ketoconazole (Nizoral®), rifampin (Rifadin®, Rimactane®), or medicine to treat depression (such as imipramine, Tofranil®, sertraline, Zoloft®).
- Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Using these together with zolpidem may increase the risk of side effects.
- Do not drink alcohol while you are using this medicine.
Warnings While Using This Medicine:
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, myasthenia gravis, lung disease, or breathing problems, including sleep apnea. Tell your doctor if you have ever been addicted to alcohol or other drugs (including street drugs), or if you have a history of depression or mental illness.
- Tell your doctor if you develop any unusual thoughts or behaviors. This includes aggressive behavior, confusion, hallucinations (seeing, hearing, or feeling things that are not there), anxiety, depression, or thoughts of hurting yourself.
- This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you. Be especially careful in the morning after you take a dose, because the medicine could still be working and making you less alert.
- This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that this has happened.
- For some people, this medicine stays in the body longer that it does for other people. This means that you might still feel sleepy and less alert the next morning, because the medicine is still working. Tell your doctor if this happens. Women are more likely to have this problem than men are, so women should get a lower starting dose than men do.
- This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working. If you take this medicine every night, you might have side effects for a few days when you stop using it. This includes nausea, vomiting, crying, and trouble sleeping.
- Call your doctor if you still have trouble sleeping after using this medicine for 7 to 10 days.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Anxiety, agitation, depression, nervousness, unusual behavior, thoughts of hurting yourself
- Seeing, hearing, or feeling things that are not there
- Severe confusion, drowsiness, muscle weakness
If you notice these less serious side effects, talk with your doctor:
- Daytime drowsiness
- Diarrhea, nausea
- Hangover feeling
- Headache, lightheadedness, or dizziness
- Memory loss
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Last Updated: 11/4/2014
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