ZOLPIMIST (zolpidem tartrate) Oral Spray, 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 the time it takes to fall asleep for up to 35 days in controlled clinical studies.

Important Safety Information

Zolpimist is indicated for the short-term treatment of insomnia.

When you first start taking Zolpimist and until you know how you will react to this medication, use caution in the morning when you engage in activities requiring complete alertness. In most instances, memory problems can be avoided if you take Zolpimist only when you can sleep full night (e.g., 7 to 8 hours) before your planned awakening time. As with any sleep medication, do not use alcohol while you are taking Zolpimist. Tell your provider about all your health conditions and all the medicines you take, including prescriptions, nonprescriptions, and dietary supplements.

Sleepwalking, eating, or driving while not fully awake, without memory of the event, and rare incidents of allergic reactions, have been reported. If you have any of these experiences, contact your provider immediately.

Prescription sleep medicines are often taken for 7 to 10 days, perhaps longer if prescribed by your provider. Like many sleep aids, Zolpimist has some risk for dependency.

With short-term use, Zolpimist has a low incidence of side effects. In clinical trials, the most commonly reported side effects were drowsiness (2%), dizziness (1%), and diarrhea (1%).

The recommended initial Zolpimist dosage for women and elderly persons is 5 mg, for men 5 mg or 10 mg, immediately before bedtime, with at least 7 -8 hours remaining before the planned time of awakening.

To report suspected adverse events or product complaints, please call MAGNA Pharmaceuticals at 1.888.206.5525; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.