Edluar

Generic Name: zolpidem (zole PI dem)
Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

What is Edluar?

Edluar (zolpidem) is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Edluar sublingual tablets are used for the short treatment of insomnia where individuals are finding it difficult to fall asleep.

Edluar may also be used for purposes not listed in this medication guide.

Important information about Edluar

Edluar may cause a severe allergic reaction. Stop taking Edluar and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Edluar and talk with your doctor about another treatment for your sleep disorder.

Edluar may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not take this medicine if you have consumed alcohol during the day or just before bed.

Edluar may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

Before taking Edluar

Some people using Edluar have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Edluar and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem.

To make sure you can safely take Edluar, tell your doctor if you have any of these other conditions:

• kidney disease;
• liver disease;

• lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);

• sleep apnea (breathing stops during sleep);

• myasthenia gravis;

• a history of depression, mental illness, or suicidal thoughts; or

• a history of drug or alcohol addiction.

Edluar may be habit forming and should be used only by the person it was prescribed for. Never share Edluar with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Edluar will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The sedative effects of Edluar may be stronger in older adults. Do not give this medicine to anyone younger than 18 years of age.

See also: Edluar pregnancy and breastfeeding warnings (in more detail)

How should I take Edluar?

Take Edluar exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not swallow the Edluar tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water. For faster sleep onset, Edluar should not be taken with or right after a meal.

Edluar comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Never take Edluar if you do not have a full 7 to 8 hours to sleep before being active again.

Edluar is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take Edluar for longer than 4 or 5 weeks without your doctor's advice. Do not stop using Edluar suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking Edluar. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking Edluar.

Store Edluar at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Edluar is taken only at bedtime, you will not be on a frequent dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Edluar can be fatal when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while taking Edluar?

Edluar may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Avoid taking Edluar during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Edluar.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

See also: Edluar and alcohol (in more detail)

Edluar side effects

Edluar may cause a severe allergic reaction. Stop taking Edluar and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using Edluar and call your doctor at once if you have a serious side effects:

• chest pain, fast or irregular heartbeat, feeling short of breath;

• trouble breathing or swallowing; or

• feeling like you might pass out.

Less serious Edluar side effects may include:

• daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;

• tired feeling, loss of coordination;

• dry mouth, nose or throat irritation;

• nausea, constipation, diarrhea, upset stomach;

• stuffy nose, sore throat; or

• headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Edluar side effects (in more detail)

What other drugs will affect Edluar?

You may need a lower dose of Edluar if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.

Tell your doctor about all other medicines you use, especially:

• chlorpromazine (Thorazine);

• itraconazole (Sporanox), ketoconazole (Nizoral);

• rifampin (Rifadin, Rimactane, Rifater); or

• antidepressants such as imipramine (Tofranil), or sertraline (Zoloft).

This list is not complete and other drugs may interact with Edluar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Edluar.