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Efficacy: Zolpidem tartrate, the #1-prescribed sleep agent,1 has been found to shorten the time it takes to complete the transition from being fully awake to being asleep.2
EDLUAR sublingual tablets contain the active ingredient zolpidem tartrate and have a pharmacokinetic profile characterized by rapid absorption.1
For more safety information click here.
EDLUAR is different because it provides the #1-prescribed sleep molecule, zolpidem tartrate, in a sublingual tablet. Your patients won't have to disturb their sleep routine by getting out of bed to pour a glass of water - they just simply place the tablet under the tongue and let it dissolve. In fact, EDLUAR sublingual tablets should not be swallowed, taken with water, other liquids or food.
Studies show that adults who have trouble getting to sleep for a few nights or a few weeks may benefit from EDLUAR.
Once-daily EDLUAR sublingual tablets may help patients suffering from sleep-onset insomnia
For eligible, insured patients only. Offer covers 100% of the copay for the first prescription dispensed (up to 30 tablets and a maximum value of $100). For additional fills, patient pays plan copay amount up to $20; the offer covers the balance of the copay over $20, if any (up to 30 tablets and a maximum value of $80 per fill). Limit 4 additional fills per patient. Click here to download your card.
References:
1. IMS Health, NPA. Monthly Rx. January to June 2009.
2. EDLUAR [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2009.
3. Adult outpatients with chronic insomnia (n=75) were evaluated in a double-blind, parallel-group, 5-week trial comparing two doses of zolpidem tartrate and placebo. • On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for Weeks 2 and 4. • Zolpidem was comparable to placebo on number of awakenings at both doses studied.
4. Adult outpatients (n=141) with chronic insomnia were also evaluated in a double-blind, parallel-group, 4-week trial comparing two doses of zolpidem and placebo.• Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week.
5.See Dosing/Administration tab for information about elderly, debilitated, and hepatically impaired patients.
6.Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of zolpidem tartrate. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), i.e., these subjects experienced anterograde amnesia. • There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of zolpidem tartrate, predominantly at doses above 10 mg.
7. There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate. • There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses of zolpidem tartrate above the recommended elderly dose of 5 mg.
The most commonly observed adverse reactions in controlled studies were drowsiness, dizziness, diarrhea, and drugged feelings.
Please see Full Prescription Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
