Taking Edluar

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

Take note

  • Edluar is absorbed fast—that's why you should take it right before going to bed
  • Edluar should not be taken with—or immediately after—a meal
  • Place Edluar under your tongue and let it dissolve there on its own
  • Don't swallow Edluar or take it with any liquids
  • Take Edluar only if you're able to stay in bed for a full night's sleep (7 to 8 hours)

Reference: 1. Edluar [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2014.

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.