Zolpidem (Into the mouth)

Brand Name(s)

Zolpimist

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using chlorpromazine (Thorazine®), imipramine (Tofranil®), itraconazole (Sporanox®), ketoconazole (Nizoral®), rifampin (Rimactane®, Rifadin®), or sertraline (Zoloft®).
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, depression, nervousness, unusual behavior, or thoughts of hurting yourself.
• Chest pain, shortness of breath, or troubled breathing.
• Fast or pounding heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Severe confusion, drowsiness, or muscle weakness.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Dry mouth, constipation, or diarrhea.
• Hangover feeling.
• Headache.
• Memory loss.
• Rash.
• Tiredness.
• Trouble concentrating.

Introduction

Zolpidem (zole-PI-dem)

Treats insomnia (trouble sleeping). This medicine is a sedative-hypnotic.

How to Use This Medicine

Spray

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is not for long-term use.
• This medicine is usually taken just before bedtime, or when you are having trouble falling asleep. You should not use this medicine if you are not able to sleep or rest for about 7 to 8 hours before you need to be active again.
• This medicine should not be taken with food or right after a meal. It is best to take this medicine on an empty stomach.
• If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.
• To use the oral spray: First, pull the child-resistant cap to separate it from the base. Then, remove the clear protective cap from the pump. 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 (5 mg) of this medicine is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given. Put the clear protective cap back over the pump after each use.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• Use this medicine only when you cannot sleep. You do not need to keep a schedule for taking it.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in an upright position.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed. Throw the child-resistant container of the oral spray when the 60 sprays have already been used.
• Keep all medicine away from children and never share your medicine with anyone.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, myasthenia gravis (severe muscle weakness), lung disease, or breathing problems including sleep apnea. Tell your doctor if you have ever abused alcohol or other drugs, or if you have a history of depression or mental illness.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, or mouth when you take this medicine.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. This medicine may also cause sleep-related behaviors such as sleep-driving, sleep-walking, having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions. If you continue to have sleeping problems after using this medicine for 7 to 10 days, check with your doctor.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088