Who should not take Intermezzo

Do not take Intermezzo 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.

Intermezzo may not be right for you. Before starting Intermezzo, tell your doctor about all of your health conditions, including if you:

• Have had an allergic reaction to a prescription sleep aid because it may have contained zolpidem
• 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

You should also tell your doctor about any medications you are taking because some medications may interact with each other, causing serious side effects.

It is not known if Intermezzo is safe and effective in children; therefore, it is not recommended for people under 18 years old.

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.