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.

• Purdue Pharma LP

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.

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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Intermezzo there are no specific foods that you must exclude from your diet when receiving Intermezzo.

Before receiving Intermezzo, tell your doctor about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

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.

Take Intermezzo exactly as prescribed. Do not take more Intermezzo than prescribed for you.

• While in bed, place the tablet under your tongue and allow it to break apart completely. Do not swallow it whole.
• You should not take Intermezzo with or right after a meal. Intermezzo may help you fall asleep faster when you take it on an empty stomach.
• Call your health care provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Instructions for Use

Read these Instructions for Use before you start taking Intermezzo and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important Information I should know about Intermezzo?

Follow these Instructions for Use when you take Intermezzo. If you do not follow these instructions, you might be drowsy in the morning without knowing it.

• Only take 1 tablet a night if needed
• Only take Intermezzo if you have at least 4 hours of bedtime left

Using Intermezzo the wrong way can make you drowsy in the morning.

Before you go to bed:

Place only 1 Intermezzo pouch by your bed, and have a clock or watch nearby.

• Store all other unopened Intermezzo pouches with your other medicines away from your bedside.
• Only open the Intermezzo pouch when you are ready to use it.
• You can either use the Intermezzo Dosing Time Chart or the Dosing Time Tool that comes with Intermezzo to find the latest time during the night you can take Intermezzo.

Intermezzo Dosing Time Chart:

• You can take Intermezzo if you have at least 4 hours of bedtime left before you must be awake.
• Find the earliest time you have to be up and awake in the column on the left.
• Find the latest time you can take Intermezzo on the same line in the column on the right.

Intermezzo Dosing Time Tool:

• Turn the Intermezzo Dosing Time Tool wheel to show the earliest time that you must be awake under the green arrow.
• Take Intermezzo before the time under the brown arrow.

During the night when you take Intermezzo:

Step 1. Check the current time and use the Intermezzo Dosing Time Chart or the Intermezzo Dosing Time Tool to decide if you should take Intermezzo.

• Only take Intermezzo if you have at least 4 hours of bedtime left before you have to be awake.

Step 2. Open the Intermezzo pouch you placed by your bed.

Fold the Intermezzo pouch along the dotted line. While the Intermezzo pouch is folded, tear the pouch open at the notch at the center of the dotted line.

Step 3. Remove the tablet from the Intermezzo pouch.

Step 4. Leave the empty Intermezzo pouch where you can see it. The empty pouch will help remind you that you already took your Intermezzo dose.

Step 5. While in bed, place the Intermezzo tablet under your tongue and allow it to break apart completely, then swallow. Do not swallow it whole.

Step 6. Throw the empty Intermezzo pouch away in the morning.

When you wake up in the morning, be sure that at least 4 hours have passed since you have taken Intermezzo and you feel fully awake before driving. Do not do dangerous activities until you know how Intermezzo affects you.

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.

If you take too much Intermezzo call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Intermezzo at room temperature at 68° to 77°F (20° to 25°C).
• Protect Intermezzo from moisture.
• Keep Intermezzo and all medicines out of reach of children.
• 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.

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.