Patient Instructions for Use

Zolpimist (zolpidem tartrate) Oral Spray, Metered For Oral Use

Be sure to carefully read, understand, and follow these instructions so that you use Zolpimist the right way. Ask your doctor or pharmacist if you have any questions about how to use Zolpimist.

patient instructions

Taking a dose of Zolpimist

  • If you are using Zolpimist for the first time or you have not used Zolpimist for 14 days, you will need to prime the pump (Steps 1-6). Otherwise, there is no need to prime the pump.
  • Take Zolpimist exactly as prescribed. Do not take more Zolpimist than prescribed for you. Your doctor will tell you whether to take 1 or 2 sprays of Zolpimist.
  • Take Zolpimist right before you get into bed.
  • Do not take Zolpimist unless you are able to stay in bed a full night (7-8 hours) before you must be active again.

Priming

Before you use Zolpimist for the first time or if you have not used Zolpimist for 14 days, you will need to prime the pump (Steps 1-6). Otherwise, there is no need to prime the pump.

  1. Line up the arrows on the child-resistant cap and base (see Figure 1).
  2. Squeeze the cap at arrows (see Figure 2).
  3. Pry the cap and base to separate (see Figure 3).
  4. Remove the clear protective cap from the pump (see Figure 4).
  5. Hold the container upright. Point the black spray opening in a safe direction away from your face and other people. Fully press down on the pump with your forefinger. Release the pump and let the pump return to the starting position.
  6. Follow step 5 and press down on the pump 4 more times. You should see a fine spray. Zolpimist is now ready to use.
  7. Line up the arrows on the child-resistant cap and base (see Figure 1).
  8. Squeeze the cap at arrows (see Figure 2).
  9. Pry the cap and base to separate (see Figure 3).
  10. Remove the clear protective cap from the pump (see Figure 4).
  11. Hold the container upright with the black spray opening pointed directly into your mouth. Fully press down on the pump to make sure that a full dose of Zolpimist is sprayed directly into your open mouth over your tongue (see Figure 5).
  12. Let the pump return to the starting position. If your doctor prescribed only one spray of Zolpimist (5 mg dose), go directly to Step 14.
  13. If your doctor prescribes a second spray of Zolpimist (10 mg dose), repeat Step 11.
  14. Put the clear protective cap back over the pump at the top of the child-resistant base after each use (see Figure 6).
  15. Snap the child-resistant cap back onto the base and rotate the child-resistant cap and the child-resistant base so that the arrows are not lined up (see Figure 7).
  16. The child-resistant container should be thrown away when the 60 sprays have been used.

taking a dose of zolpimist

Know the signs

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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

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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

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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.

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Important Safety Information

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

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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.

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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.

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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.

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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%).

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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.

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To report suspected adverse events or product complaints, please call Aytu BioScience at zolpimist@aytubio.com; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.