Intermezzo® (zolpidem tartrate) sublingual tablets CIV

Intermezzo is a prescription sleep aid for use as needed to help treat adults with insomnia when they have difficulty falling back to sleep after waking up in the middle of the night. Only take Intermezzo if you have at least 4 hours of bedtime left.

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.


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Intermezzo® (zolpidem tartrate) sublingual tablets CIV

Do you wake up in the middle of the night, and find it hard to fall back asleep? If so, you may have a condition called middle-of-the-night insomnia.

If you think you have middle-of-the-night insomnia, you should talk to your doctor about steps you can take to help you fall back to sleep.  You can also discuss a prescription treatment option called Intermezzo®.

What is Intermezzo®?

Many adults wake up in the middle of the night and have difficulting falling back to sleep.  Intermezzo is designed specifically to treat this problem and help you fall back asleep. Intermezzo is the first and only prescription sleep aid approved by the FDA for use when you wake up in the middle of the night and can’t get back to sleep.

You only take it when you need it and if you have at least 4 hours of sleep left.

Intermezzo is a C-IV controlled substance and, like most sleep medicines, has some risk of dependency.   Please read the important safety information below.

Find out more at myintermezzo.com

Save on your prescription with the Intermezzo Patient Savings Program

With the Intermezzo Patient Savings Program, you can receive a free trial with the Intermezzo Trial Offer (to be used with a valid prescription of Intermezzo).

You may also be eligible for an Intermezzo Savings Card to save on each prescription of Intermezzo.

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.

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