Edluar Warnings and Precautions

Edluar Drug Information

What Should I Tell My Healthcare Provider Before Taking Edluar?

You should talk with your healthcare provider prior to taking Edluar™ (zolpidem sublingual tablet) if you have:

Liver disease or liver failure, including cirrhosis
Depression
Sleep apnea or other types of respiratory disease, such as emphysema or COPD
A history of drug or alcohol abuse
Any allergies, including allergies to foods, dyes, or preservatives.

Also, let your healthcare provider know if you are:

Pregnant or thinking of becoming pregnant
Breastfeeding.

In addition, tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Edluar Warnings and Precautions

Warnings and precautions to be aware of prior to taking Edluar include the following:

Sometimes sleeping problems are caused by other medical conditions, not just insomnia. If your insomnia does not improve within 7 to 10 days of starting Edluar, your healthcare provider should make sure no other medical condition is causing your sleeping problems.
Seek immediate medical attention if you experience swelling of the mouth or throat. Rare cases of life-threatening allergic reactions involving these symptoms have been reported with zolpidem (the active ingredient in Edluar).
You should only take this medication if you are able to get a full seven or eight hours of sleep. Never drive or operate heavy machinery after you have taken an Edluar dosage, even if you do not feel drowsy yet.
If you drink alcohol, let your healthcare provider know prior to starting Edluar. In general, people should not use alcohol when taking this medicine because it can increase the risks of developing serious side effects.
If you notice any changes in your behavior, such as anything unusual or disturbing, while taking Edluar or other sleep medicines, notify your healthcare provider immediately. Bizarre thoughts or behavior have been reported with this drug.
Be aware that you may get out of bed while not fully awake and do things that you may not remember, such as sleep-walking or sleep-eating. If this happens, your healthcare provider will probably recommend that you stop taking Edluar.
This medicine should be used with caution in people with sleep apnea or other breathing problems, as it could make such conditions worse.
Edluar has been reported to cause or worsen depression. Let your healthcare provider know if you think you may be depressed or if your depression is worsening during treatment.
Liver disease may affect the way that your body handles Edluar and you may need a lower dose as a result.
Edluar is a controlled substance, which means it has some abuse potential. It may not be the best choice for people with a history of drug or alcohol abuse.
Edluar can potentially interact with several other medications (see Edluar Drug Interactions).
Edluar is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are not known (see Edluar and Pregnancy).
This medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Edluar and Breastfeeding).

(Edluar Warnings and Precautions Continued: Page 2)