Edluar is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Edluar sublingual tablets (dissolve under the tongue) are used for the short treatment of insomnia where individuals are finding it difficult to fall asleep when they first go to bed.

Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse.

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.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Edluar may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take Edluar in larger amounts or for longer than prescribed.

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

Some people using Edluar have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking this medicine and talk with your doctor about another treatment for your sleep disorder.

Take Edluar exactly as prescribed by your doctor. Follow all directions on your prescription label. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Never take this medicine in larger amounts, or for longer than prescribed.

The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.

Do not share this medication with another person, even if they have the same symptoms you have. Edluar is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Do not swallow the Edluar sublingual tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.

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 this medicine 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 this medicine. 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 this medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Insomnia:

Edluar sublingual tablets:
-Initial Dose: 5 mg (women) OR 5 mg or 10 mg (men) once a day immediately prior to bedtime
-Maintenance Dose: The dose may be increased to 10 mg if the 5 mg dose is not effective.
-Maximum Dose: 10 mg once a day.
-Duration of Therapy: The clinical trials in support of efficacy were 4 to 5 weeks in duration.

Comments: The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.

Use: Short-term treatment of insomnia characterized by difficulties with sleep initiation.

Usual Geriatric Dose for Insomnia:

Edluar sublingual tablets:
-Both men and women over the age of 65 years: 5 mg once a day immediately prior to bedtime
-Maximum dose: 5 mg once a day

Comments: Doses are the same in men and women.

Use: Short-term treatment of insomnia characterized by difficulties with sleep initiation.

You should not use Edluar if you are allergic to zolpidem.

Edluar is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or suicidal thoughts;

• drug or alcohol addiction;

• lung disease or breathing problems;

• sleep apnea (breathing stops during sleep); or

• liver or kidney disease.

Taking Edluar in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Since Edluar is taken only at bedtime if needed, you are not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially 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.

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

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy the morning after taking this medicine, and your reactions could be impaired. Wait 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.

Zolpidem may cause a severe allergic reaction. Stop taking Edluar and get emergency medical help if you have signs of an allergic reaction to zolpidem: 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:

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

• trouble breathing or swallowing; or

• feeling like you might pass out.

The sedative effect of zolpidem may be stronger in older adults.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common Edluar side effects may include:

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

• tired feeling, loss of coordination;

• stuffy nose, dry mouth, nose or throat irritation;

• nausea, constipation, diarrhea, upset stomach; 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.

Using Edluar with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.