About Edluar

Do you have trouble falling asleep?
Edluar may be able to help

If you have trouble falling asleep, you might have what is called sleep-onset insomnia. Perhaps you've tried changing your sleep routine OR taking an over-the-counter sleep aid. But if you're like many Americans, you still have trouble falling asleep.

Why not ask your healthcare provider about prescription Edluar?

Edluar sublingual tablets contain zolpidem tartrate, the #1 prescribed sleep agent that, for more than 20 years, has helped millions of people fall asleep.

How Edluar works differently

Prescription Edluar sublingual tablets are different because they are "sublingual"—which means you place the tablet under your tongue to dissolve when you want to fall asleep.

How Edluar may help you get to sleep

When you need to fall asleep, immediately before getting into bed, place an Edluar sublingual tablet under your tongue, were it will dissolve. If you find that you can't fall asleep after going to bed (and you haven't taken a sleep aid), you can take Edluar without getting up for water. Be sure you have time for a full night's sleep (7 to 8 hours) before being active again. Edluar sublingual tablets should not be taken with water, other liquids, or food.

Edluar sublingual tablets may help you get a better night's sleep:

  • Reduce the time it takes to fall asleep
  • Increase sleeping time
  • Reduce nighttime awakenings

Ask your healthcare provider if Edluar sublingual tablets are right for you.

Questions to ask your doctor

If you've decided to talk to your healthcare provider about your sleeping problems, write down everything that might be connected to your insomnia. Then take that list to your appointment.

Here are some questions to ask your doctor:

  • If I have trouble falling asleep several nights a week, do I have insomnia?
  • Can any of the medicines I'm currently taking cause me to have trouble falling asleep?
  • What types of activities could prevent me from falling asleep?
  • When should I exercise so that it does not affect my sleep?
  • How can I make my bedroom a good place to sleep?
  • How long before going to bed should I stop drinking caffeine-containing beverages so I can fall asleep?
  • Is it okay for me to nap during the day?
  • Are Edluar sublingual tablets right for me?

References: 1. Edluar [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2014. 2. IMS Health Inc. Prescription Sleep Aid Database, April 2016. 3. US Department of Health and Human Services. Ambien® (zolpidem) tablets BPCA drug use review. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4399b1-18%20(Ambien%20(zolpidem)%20Use%20Review).pdf. Published June 30, 2008. Accessed June 20, 2016. OCE RCM #2007-256.

More Important Safety Information

Do not take more Edluar than prescribed.

Do not take Edluar unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
Take Edluar right before you get in bed, not sooner.

Edluar may cause serious side effects, including:
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 many not remember that you did anything during the night.

Reported activities include:

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

Call your healthcare provider right away if you find out that you have done any of the above activities after taking Edular.

Do not take Edluar if you:

  • drank alcohol that evening or before bed
  • took another medicine to help you sleep

Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence.

Edluar may not be right for you. Before starting Edluar, tell your healthcare provider about all of your health 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 lung disease or breathing problems
  • are pregnant or planning to become pregnant. It is not known if Edluar will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Edluar can pass into your breast milk. It is not known if Edluar will harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take Edluar.

Medicines can interact with each other, sometimes causing serious side effects.

Do not take Edluar with other medicines that can make you sleepy, unless directed by your healthcare provider.

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.

Do not take Edluar if you are allergic to zolpidem or any other ingredients in Edluar.

Do not take Edluar if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Zolpimist, or Intermezzo.

Do not take Edluar if you drank alcohol that evening or before bed.

Edluar may cause serious side effects, including:

  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing.
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions.
  • memory loss
  • anxiety
  • severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing. Get emergency medical help if you get these symptoms after taking Edluar.

The most common side effects of Edluar are:

  • drowsiness
  • dizziness
  • diarrhea
  • grogginess or feeling as if you have been drugged
  • fatigue
  • headache

Approved Uses

Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

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

These are not all the side effects of Edluar. Ask your doctor or pharmacist for more information. You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please read the Medication Guide for Edluar and discuss it with your doctor.