Intermezzo

Intermezzo is a prescription medication used in adults for the treatment of insomnia. Intermezzo helps those patients that have difficulty returning to sleep after awakening in the middle of the night. Intermezzo belongs to a group of drugs called hypnotics. It works by slowing down brain activity so you can fall asleep.

Intermezzo comes as a sublingual tablet and is taken by mouth at night, if needed, without food. While in bed, place the tablet under your tongue and allow it to break apart completely. Do not swallow it whole.

Intermezzo is taken only if you have at least 4 hours of bedtime left.

Common side effects of Intermezzo include headache, nausea, and fatigue.

Intermezzo can cause daytime drowsiness and dizziness, and diarrhea. Do not drive or operate heavy machinery until you know how Intermezzo affects you.

Intermezzo is a prescription medication used in adults for the treatment of insomnia. Intermezzo helps those patients that have difficulty returning to sleep after awakening in the middle of the night. It slows brain activity to allow sleep.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take Intermezzo exactly as your doctor has prescribed it. Follow the directions on your prescription label carefully. 

Intermezzo Sublingual Tablet

The recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime.

For geriatric patients and patients with liver impairment, the recommended dose is 5 mg for men and women.

Intermezzo is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Intermezzo in a safe place to prevent misuse and abuse. Selling or giving away Intermezzo may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

After taking Intermezzo, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You should be aware that impairment from sleep drugs can be present despite feeling fully awake. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Intermezzo.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Intermezzo.

• Take Intermezzo by mouth at night, if needed.
• Do not take Intermezzo if you do not have at least 4 hours of bedtime left.
• Do not take Intermezzo if you drank alcohol that evening or before bed.
• Do not take Intermezzo with other medicines that can make you sleepy. 
• Do not take Intermezzo if you are allergic to anything in it. Severe allergic reactions have occurred with Intermezzo use. Seek emergency medical attention if you have unexplained rash, itching, hives, wheezing or trouble breathing, or unexplained swelling (especially of the throat, lips, or mouth).
• Do not take Intermezzo if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Edluar, or Zolpimist.

Intermezzo can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Intermezzo affects you.

Warning: Impairment from sleep drugs can be present despite feeling fully awake.

You may still feel drowsy the next day after taking Intermezzo. Do not drive or operate heavy machinery or take part in anything that requires alertness after taking Intermezzo until you are certain you are alert.

Serious side effects of Intermezzo may include:

• getting out of bed while not being fully awake and taking part in an activity that you do not know you are doing
• abnormal thoughts and behavior including:
  • more outgoing or aggressive behavior than normal
  • confusion 
  • agitation
  • hallucinations (seeing or hearing things that aren't there)
  • worsening of depression
  • suicidal thoughts or actions
• memory loss
• anxiety
• severe allergic reactions including:
• swelling of the tongue or throat
• trouble breathing
• nausea and vomiting

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Intermezzo.

The most common side effects of Intermezzo are:

• Headache
• Nausea
• Fatigue

Some people experience symptoms such as trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain after stopping sleep medicine. This may last a couple days. 

This is not a complete list of Intermezzo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Do not take Intermezzo with other medicines that make you sleepy. Be sure to tell your doctor if you take:

• antidepressants such as imipramine (Tofranil) and sertraline (Zoloft)
• chlorpromazine (Thorazine)
• antifungal medicines such as itraconazole (Sporanox) and  ketoconazole (Nizoral)
• medications for anxiety
• cold medicines or allergy medicines
• medicines for mental illness
• pain medicines
• medicines for seizures
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers

This is not a complete list of Intermezzo drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or are planning to breastfeed. Intermezzo is excreted into human milk. It is not known if Intermezzo will harm your nursing baby.

You may still feel drowsy the next day after taking zolpidem. Do not drive or operate heavy machinery or take part in anything that requires alertness after taking zolpidem until you are certain you are alert.

After taking zolpidem, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking