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Zolpidem (Mucous Membrane) (Spray, Tablet)

(EDLUAR)
Zolpidem (Into the mouth)
Zolpidem (zole-PI-dem)Treats insomnia.
Edluar , Intermezzo , Zolpimist

When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to zolpidem.

How to Use This Medicine:
Spray, Tablet

  • Your doctor will tell you how much medicine to use. Do not use more than directed. This medicine is used only when you cannot sleep. You do not need to take it on a regular schedule.
  • This medicine is usually taken at bedtime. Do 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.
  • The Intermezzo® brand is taken if you wake up in the middle of the night and have trouble falling back to sleep. Do not take it unless you have at least 4 hours to sleep or rest before you need to be active again.
  • It is best to take this medicine on an empty stomach.
  • Oral spray:
    • You must prime the oral spray the first time you use it. To do this, spray the medicine 5 times away from your face and other people. The medicine is now ready to use. If the oral spray has not been used for 14 days, it must be primed again.
    • To use: Remove both caps from the pump. Hold the container upright with the black spray opening pointed into your mouth. Press the pump completely to make sure that a full dose (5 mg) is given. If your dose is 10 mg, use a second spray. Put the protective cap back over the pump after each use.
  • Sublingual tablet:
    • Do not open the blister pack until you are ready to take your medicine. Do not use the tablet if the seal of the blister pack is broken. Do not use a broken tablet.
    • Different brands have different packaging. To remove the tablet, either fold the pouch along the dotted line and tear open at the notch, or peel back the paper and push the tablet through the foil.
    • Place the tablet under your tongue. Let it dissolve completely. 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.
  • 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. Throw away the container when 60 sprays have been used.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some medicines can affect how zolpidem works. Tell your doctor if you are using ketoconazole or rifampin.
  • Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, lung disease, breathing problems such as sleep apnea, or myasthenia gravis. Tell your doctor if you have a history of alcohol or drug addiction, depression, or mental health problems.
  • This medicine may make you dizzy or drowsy, especially first thing in the morning. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
  • This medicine may cause unusual moods and behaviors. You may also do things while you are still asleep that you may not remember the next morning, such as driving. Tell your doctor right away if you learn that this has happened. Also tell your doctor if you have any mood or behavior changes that concern you.
  • 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.
  • Call your doctor if you still have trouble sleeping after using this medicine for 7 to 10 days.
  • This medicine is not for long-term use.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, depression, unusual behavior, thoughts of hurting yourself
  • Confusion, severe drowsiness, muscle weakness
  • Memory loss
  • Seeing, hearing, or feeling things that are not there

If you notice these less serious side effects, talk with your doctor:

  • Daytime drowsiness

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