Edluar

Edluar is a prescription medication used in adults for the short-term treatment of insomnia (difficulty falling asleep). Edluar belongs to a group of drugs called hypnotics. It works by slowing down brain activity so you can fall asleep.

Edluar comes as a sublingual tablet and is taken by mouth at night and only if needed, without food. Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.

Common side effects of Edluar include daytime drowsiness, dizziness, and diarrhea. Do not drive or operate heavy machinery until you know how Edluar affects you.

Edluar is a prescription medicine used in adults for the treatment of a sleep problem called insomnia (difficulty falling asleep). It slows brain activity to allow sleep.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Meda Pharmaceuticals, Inc.

Warning: Impairment from sleep drugs can be present despite feeling fully awake.

You may still feel drowsy the next day after taking Edluar. Do not drive or operate heavy machinery or take part in anything that requires alertness after taking Edluar until you are certain you are alert.

Serious side effects of Edluar may include:

• getting out of bed while not being fully awake and taking part in an activity that you do not know you are doing
• abnormal thoughts and behavior including:
  • more outgoing or aggressive behavior than normal
  • confusion 
  • agitation
  • hallucinations (seeing or hearing things that aren't there)
  • worsening of depression
  • suicidal thoughts or actions
• memory loss
• anxiety
• severe allergic reactions including:
• swelling of the tongue or throat
• trouble breathing
• nausea and vomiting

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Edluar.

The most common side effects of Edluar are:

• drowsiness
• dizziness
• diarrhea
• "drugged feelings"
• fatigue
• headache

Some people experience symptoms such as trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain after stopping sleep medicine. This may last 1-2 days. 

This is not a complete list of Edluar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Do not take Edluar with other medicines that make you sleepy. Be sure to tell your doctor if you take:

• antidepressants such as imipramine (Tofranil) and sertraline (Zoloft)
• chlorpromazine (Thorazine)
• antifungal medicines such as itraconazole (Sporanox) and  ketoconazole (Nizoral)
• medications for anxiety
• cold medicines or allergy medicines
• medicines for mental illness
• pain medicines
• medicines for seizures
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers.

This is not a complete list of Edluar drug interactions. Ask your doctor or pharmacist for more information.

After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You should be aware that impairment from sleep drugs can be present despite feeling fully awake. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Edluar.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Edluar.

• Take Edluar right before you get in bed, not sooner.
• Do not take Edluar if you drank alcohol that evening or before bed.
• Do not take Edluar with other medicines that can make you sleepy. 
• Do not take Edluar if you cannot get a full night's sleep or stay in bed 7 or 8 hours before being active again.
• Do not take Edluar if you are allergic to anything in it. Severe allergic reactions have occurred with Edluar use. Seek emergency medical attention if you have unexplained rash, itching, hives, wheezing or trouble breathing, or unexplained swelling (especially of the throat, lips, or mouth).
• Do not take Edluar if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Zolpimist, or Intermezzo.

It is not known if Edluar is safe and effective in children under the age of 18 years.

Edluar can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Edluar affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Edluar there are no specific foods that you must exclude from your diet when receiving Edluar.

Before receiving Edluar, tell your doctor about all of your medical conditions, including if you:

• 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

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or are planning to breastfeed. Edluar is excreted into human milk. It is not known if Edluar will harm your nursing baby.

Take Edluar exactly as prescribed. Do not take more Edluar than prescribed for you.

• Take Edluar right before you get into bed.
• Only take 1 Edluar tablet a night and only if needed.
• Do not take Edluar if you drank alcohol that evening or before bed.
• You should not take Edluar with or right after a meal. Edluar may help you fall asleep faster if you take it on an empty stomach.
• Do not use the tablet if the seal on the childproof blister pack is broken, or if the blister holding the tablet is broken.
• To open the blister pack, separate the individual blisters at the perforations. Peel off the top layer of paper, and push the tablet through the foil.
• Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
• Call your healthcare provider 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.

Take Edluar exactly as your doctor has prescribed it. Follow the directions on your prescription label carefully. 

Edluar Sublingual Tablet

The recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime.

For geriatric patients and patients with liver impairment, the recommended dose is 5 mg for men and women.

In addition, your dose may be reduced if you take certain medications.

If you take too much Edluar call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Edluar between 68°F and 77°F (20° to 25°C).
• Protect from light and moisture.
• Keep Edluar and all medicines out of reach of children.
• Edluar is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law.

Edluar is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.