About Edluar

How Edluar may help your patients sleep:
Efficacy from zolpidem tartrate—the most prescribed sleep agent—in a sublingual form!1,2

Zolpidem tartrate is a highly effective sleep aid proven over 2 decades of clinical experience.3,4

In multiple clinical trials, Edluar demonstrated1:

  • Reduction in sleep-onset latency
    • Shorter transition from being awake to falling asleep
  • Improvement in sleep quality
  • Fewer awakenings during the night
  • Increased total sleep time

For your patients who have trouble falling asleep, Edluar may help.1

Edluar safety profile

Edluar sublingual tablets, with the active ingredient zolpidem tartrate, are formulated for rapid absorption.1

In clinical studies that evaluated safety1:

  • There was no consistent evidence of next-day memory impairment
  • There was no objective evidence of rebound insomnia
  • Preservation of sleep stages was demonstrated

Edluar convenience for your patients

Edluar is different because it provides zolpidem tartrate in a sublingual tablet. Edluar should be taken immediately before bedtime. If patients haven't taken a sleep aid and find that they can't fall asleep after going to bed, they can take Edluar without getting up for water. Patients should be counseled to get a full night's sleep (7 to 8 hours) before being active again.1

Edluar tablets are designed for sublingual use and should not be swallowed or taken with water, other liquids, or food.1

Studies show that adults who have transient or chronic insomnia may benefit from taking Edluar.1

Once-daily dosing with Edluar, taken immediately before bedtime1

Start with the lowest effective dose for the patient1:

  • 5 mg or 10 mg for men
  • 5 mg for women
  • 5 mg for patients who are elderly, debilitated, or have hepatic insufficiency

References: 1. Edluar [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2014. 2. IMS Health Inc. Prescription Sleep Aid Database, April 2016. 3. US Food and Drug Administration. Drugs@FDA: FDA approved drug products. http://www.accessdata.fda.gov/scripts/cder/drugsatfda.cfm?fuseaction=Search.DrugDetails. Accessed June 20, 2016. 4. Ambien [package insert]. Bridgewater, NJ: sanofi-aventis; 2014.

More Important Safety Information

  • Edluar is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema. Cases of angioedema involving the tongue, glottis, or larynyx have been reported in patients after the first or subsequent doses of sedative-hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as dyspnea, throat closing, nausea, and vomiting that suggest anaphylaxis. Airway obstruction may occur and be fatal. Patients who develop angioedema should not be rechallenged with the drug.
  • Edluar has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Edluar and of other concomitant CNS depressants may be necessary when administered together because of the potentially additive effects. The use of Edluar with other sedative-hypnotics is not recommended.
  • The risk of next-day psychomotor impairment, including impaired driving, is increased if Edluar is taken with less than a full night of sleep remaining, if a higher than the recommended dose is taken, if co-administered with other CNS depressants, or if coadministered with other drugs that increase the blood level of Edluar. Patients should be cautioned against driving and other activities requiring complete mental alertness if taken in these circumstances.
  • Symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
  • Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including zolpidem (e.g., aggressiveness, extroversion that seems out of character, bizarre behavior, agitation, depersonalization, visual and auditory hallucinations). Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. The use of alcohol or other CNS depressants increases the risk of such behaviors. Discontinuation of Edluar should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
  • In primarily depressed patients treated with sedative-hypnotics, worsening depression, and suicidal thoughts and actions (including complete suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
  • Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Edluar is prescribed to patients with compromised respiratory function including sleep apnea and myasthenia gravis.
  • There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence.
  • During short-term treatment (up to 10 nights), the most common adverse reactions in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights), the most common adverse reactions were dizziness (5%) and drugged feelings (3%).
  • Imipramine used in combination with zolpidem produced an additive effect of decreased alertness. Similarly, chlorpromazine used in combination with zolpidem produced impaired alertness and psychomotor performance.
  • Use of rifampin, a CYP3A4 inducer, in combination with zolpidem may decrease the efficacy of zolpidem.
  • Use of ketoconazole, a potent CYP3A4 inhibitor, in combination with zolpidem increased the phamacodynamics effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.
  • There are no adequate and well-controlled studies of Edluar in pregnant women. Edluar should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
  • Zolpidem is excreted in human milk. Caution should be exercised when Edluar is administered to a nursing woman.
  • Edluar is not recommended for use in children. Safety and effectiveness in pediatric patients have not been established in pediatric patients below the age of 18.
  • Edluar contains zolpidem tartrate, a Schedule IV controlled substance.
  • Use the lowest effective dose for the patient.
  • The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. The maximum recommended dose of Edluar is 10 mg once daily immediately before bedtime.
  • The recommended dose of Edluar in geriatric patients and patients with hepatic impairment is 5 mg once daily immediately before bedtime.
  • Lower doses of CNS depressants may be necessary when taken concomitantly with Edluar.
  • The effect of Edluar may be slowed if taken with or immediately after a meal.
  • Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

Indications

Edluar (zolpidem tartrate) sublingual tablets, a gamma-aminobutyic acid (GABA) A agonist, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.

To report adverse events or product complaints, please call Meda's pharmacovigilance team at (855) 365-6095 or the FDA at 1-855-543-3784 or visit www.fda.gov/medwatch.