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Intermezzo

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Intermezzo

Intermezzo Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking zolpidem (Intermezzo)?

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.

You should not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.

To make sure zolpidem is safe for you, tell your doctor if you have:

  • kidney disease;
  • liver disease;
  • lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
  • sleep apnea (breathing stops during sleep);
  • myasthenia gravis;
  • a history of depression, mental illness, or suicidal thoughts; or
  • a history of drug or alcohol addiction.

Zolpidem may be habit forming and should be used only by the person it was prescribed for. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The sedative effects of zolpidem may be stronger in older adults.

Do not give this medicine to anyone younger than 18 years of age.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

How should I take zolpidem (Intermezzo)?

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for zolpidem. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.

Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.

Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice.

Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.

Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.

Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face. Prime the spray with 1 test spray if it has not been used for longer than 14 days.

Store at room temperature away from moisture and heat. Do not freeze. Keep the Zolpimist bottle upright when not in use.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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