Zolpidem (zole-PI-dem)

Treats insomnia (trouble sleeping).

Brand Name(s):

Edluar

When This Medicine Should Not Be Used:

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 not for long-term use.
• 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.
• Do not take this medicine if you have drank alcohol the same evening or before bedtime.
• 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 milligrams [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 it with water.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• This medicine is used only when you cannot sleep. You do not need to take it on a regular schedule.
• 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 chlorpromazine, ketoconazole, rifampin, or medicine to treat depression (including fluoxetine, imipramine, sertraline).
• Do not drink alcohol while you are using this medicine.
• 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:

• Using this medicine during the last 3 months of your pregnancy (third trimester) can harm your newborn baby. Tell your doctor right away if you are pregnant or if you think you have become pregnant while using this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, lung disease (including COPD), breathing problems (including 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. It may also make you less alert than you are normally and cause trouble with thinking or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. 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, including driving, eating, making phone calls, sleepwalking, or having sex. Tell your doctor right away if you have learned that this has happened. Also tell your doctor if you have any mood or behavior changes that concern you.
• This medicine may also cause respiratory depression, a serious breathing problem that can be life-threatening.
• 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.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Call your doctor if you still have trouble sleeping after using this medicine for 7 to 10 days.
• 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, agitation, depression, changes in mood or behavior, thoughts of hurting yourself
• Confusion, severe drowsiness, muscle weakness
• Memory loss
• Pale or blue lips, fingernails, or skin, trouble breathing
• 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