EDLUAR (zolpidem tartrate sublingual tablets)

With EDLUAR, your patients can let sleep being

For Pharmacists

Indication

EDLUAR (zolpidem tartrate sublingual tablets) CIV 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.¹

• EDLUAR is the sublingual tablet that contains the #1 prescribed sleep agent
  zolpidem tartrate
• EDLUAR is convenient - tablet is taken without any liquids

EDLUAR is non-AB rated and should not be substituted.²

• EDLUAR has no FDA-approved equivalent
• Other brands of zolpidem (i.e. Ambien^®, Ambien CR^®, and A-rated zolpidem products) are not FDA Orange Book-approved therapeutic equivalents to EDLUAR

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Dosage	NDC
5 mg	0037-6050-30
10 mg	0037-6010-30

• EDLUAR is available in 5 mg and 10 mg strength tablets for sublingual administration
• Tablets are not scored
• EDLUAR 5 mg sublingual tablets are round white, flat-faced, bevel-edged,
  with debossed V on one side
• EDLUAR 10 mg sublingual tablets are round white, flat-faced, bevel-edged,
  with debossed X on one side

Reference: 1. EDLUAR [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2009.

Reference: 2. Orange Book: Approved Products with Therapeutic Equivalents Evaluations. http:\\www.accessdata.fda.gov\scripts\cder\ob\default.cfm. Accessed July 20, 2009.

• About EDLUAR
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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.

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