Frequently asked questions about Intermezzo
Click through the sections below for important information about Intermezzo. Read the Medication Guide that comes with Intermezzo before you start taking it and each time you get a refill, as there may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
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How should I store Intermezzo?
- Store Intermezzo at room temperature, 68° to 77°F (20° to 25°C). Protect from moisture.
- Only open the pouch when you are ready to use Intermezzo.
Keep Intermezzo and all medicines out of reach of children.
How should I take Intermezzo?
- Read the “Instructions for Use” at the end of the Medication Guide for detailed instructions on how to take Intermezzo. You can also view the How to take Intermezzo section for further instructions.
- Take Intermezzo exactly as prescribed. Only take one Intermezzo tablet per night if needed.
- Do not take Intermezzo if you drank alcohol that evening or before bed.
- 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 healthcare 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.
- If you take too much Intermezzo or overdose, get emergency treatment.
Instructions for Use
Intermezzo® (in ter mét zoh)
(zolpidem tartrate) sublingual tablet C-IV
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 (see Figure A).
- 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 (see Figure B)
or the Dosing Time Tool (see Figure C) that comes with Intermezzo to
find the latest time during the night you can take Intermezzo.
Intermezzo Dosing Time Chart (see Figure B):
- 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 (see Figure C):
- 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 (see Figure B).
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 (see Figure D).
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 (see Figure E).
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 (see Figure F).
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.
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What is the most important information I should know about Intermezzo?
Follow the Instructions for Use at the end of the Medication Guide when you take Intermezzo. If you do not follow the Instructions for Use, you might be drowsy in the morning without knowing it.
- Only take one tablet a night, if needed.
- Only take Intermezzo if you have at least 4 hours of bedtime left.
Intermezzo may cause serious side effects, including:
- 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 have a higher chance for doing these activities if you drank alcohol that day 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 healthcare provider right away if you find out that you have done any of the above activities after taking Intermezzo.
Important:
- Take Intermezzo exactly as prescribed
- Do not take Intermezzo if you:
- drank alcohol that day or before bed.
- took another medicine to help you sleep.
- do not have at least 4 hours of bedtime remaining.
Who should not take Intermezzo?
- Do not take Intermezzo if you are allergic to zolpidem or any other ingredients in Intermezzo. See the end of the Medication Guide for a complete list of ingredients in Intermezzo
- Do not take Intermezzo if you have had an allergic reaction to drugs containing zolpidem, such as Ambien®, Ambien CR®, Edluar®, or Zolpimist®.
Symptoms of a serious allergic reaction to Intermezzo can include:
- swelling of your face, lips, and throat that may cause difficulty breathing or swallowing
- nausea and vomiting
Intermezzo may not be right for you. Before starting Intermezzo, tell your doctor about all of your health 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. Medicines can interact with each other, sometimes causing serious side effects. Your doctor will tell you if you can take Intermezzo with your other medicines.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
What are the possible side effects of Intermezzo?
Intermezzo may cause serious side effects, including:
- getting out of bed while not being fully awake and doing an activity that you do not know you are doing.
- abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
- memory loss
- anxiety
- severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Intermezzo.
Call your healthcare provider 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:
Even if you follow the Instructions for Use, you may still feel drowsy in the morning after taking Intermezzo. Do not drive or do other dangerous activities after taking Intermezzo until you are fully awake.
These are not all the side effects of Intermezzo. Ask your healthcare provider or pharmacist for more information.
You may report side effects to FDA at 1-800-FDA-1088.
How long do I need to wait before driving after taking Intermezzo?
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 other dangerous activities until you know how Intermezzo affects you and you feel fully awake.
Can I take Intermezzo if I drank alcohol that day?
No. Do not take Intermezzo if you drank alcohol that day or before bed. Alcohol can cause added side effects if you take it with a sleep medicine like Intermezzo.
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Important Safety Information
Do not take Intermezzo® (zolpidem tartrate) if you are allergic to zolpidem or any other ingredients in Intermezzo. Do not take Intermezzo if you have had an allergic reaction to drugs containing zolpidem, such as Ambien®.
Serious allergic reactions may occur and may be fatal. Symptoms of a serious allergic reaction to Intermezzo can include swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, and nausea and vomiting.
If Intermezzo is taken with other medicines that can make you sleepy, it can add to sleepiness caused by these medicines. Intermezzo should not be taken if you have taken another sleep medicine at bedtime or in the middle of the night. Do not drive or operate machinery until at least 4 hours after taking Intermezzo and until you feel fully awake.
Call your doctor 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.
Driving, eating, or engaging in other activities while not fully awake without remembering the event the next day have been reported. Other abnormal behaviors including being more outgoing or aggressive, as well as confusion, hallucinations, and agitation, may occur. Don’t take Intermezzo if you drank alcohol that day or before bed, as it may increase these behaviors.
In depressed patients, worsening of depression, including risk of suicide may occur.
If you experience any of these behaviors or reactions, contact your healthcare provider immediately.
Intermezzo, like most sleep medicines, has some risk of dependency.
Common side effects are headache, nausea, and fatigue.
For more information, please read the Full Prescribing Information for Intermezzo, including the Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088, or contact Purdue Pharma L.P. at 1-888-726-7535.
Ambien is a registered trademark of Sanofi.