Zolpidem (patient information)

Why is this medication prescribed

Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.

How should this medicine be used

Zolpidem comes as a tablet and an extended-release (long acting) tablet to take by mouth. It is usually taken as needed at bedtime. Zolpidem will work faster if it is not taken with a meal or immediately after a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zolpidem exactly as directed.

You will probably become very sleepy soon after you take zolpidem and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take zolpidem, and to stay in bed for 7-8 hours. Do not take zolpidem if you will be unable to remain asleep for 7-8 hours after taking the medication. If you get up too soon after taking zolpidem, you may experience memory problems.

Swallow the extended release tablets whole; do not split, chew, or crush them.

Your sleep problems should improve within 7-10 days after you start taking zolpidem. Call your doctor if your sleep problems do not improve during this time or if they get worse at any time during your treatment.

Zolpidem should normally be taken for short periods of time. If you take zolpidem for 2 weeks or longer, zolpidem may not help you sleep as well as it did when you first began to take the medication. If you take zolpidem for a long time, you also may develop dependence ('addiction'; a need to continue taking the medication) on zolpidem. Talk to your doctor about the risks of taking zolpidem for 2 weeks or longer. Do not take a larger dose of zolpidem, take it more often, or take it for a longer time than prescribed by your doctor.

Do not stop taking zolpidem without talking to your doctor, especially if you have taken it for longer than 2 weeks. If you suddenly stop taking zolpidem, you may develop unpleasant feelings or you may experience more severe withdrawal symptoms such as seizures, shakiness, stomach and muscle cramps, vomiting, sweating, and rarely, seizures.

You may have more difficulty falling asleep or staying asleep on the first night after you stop taking zolpidem than you did before you started taking the medication. This is normal and usually gets better without treatment after one or two nights.

Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking zolpidem

• tell your doctor and pharmacist if you are allergic to zolpidem or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants ('mood elevators') such as imipramine (Tofranil); itraconazole (Sporanox); medications for anxiety, colds or allergies, mental illness, pain, or seizures; rifampin (Rifadin, Rimactane); sedatives; sertraline (Zoloft);sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had depression; a problem with heavy snoring; sleep apnea (condition in which the patient briefly stops breathing many times during the night); other breathing problems such as asthma, bronchitis, and emphysema; myasthenia gravis (condition that causes weakness of certain muscles); or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking zolpidem, call your doctor. Do not breastfeed while you are taking zolpidem.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zolpidem.
• you should know that zolpidem may make you drowsy during the day, and may increase the risk that you will fall. Take extra care not to fall and do not drive a car or operate machinery until you know how this medication affects you.
• Do not drink alcohol during your treatment with zolpidem. Alcohol can make the side effects of zolpidem worse.
• you should know that some people who took zolpidem got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep. After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else while you were sleeping.
• you should know that your mental health may change in unexpected ways while you are taking this medication. It is hard to tell if these changes are caused by zolpidem or if they are caused by physical or mental illnesses that you already have or suddenly develop. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, difficulty concentrating, slowed speech or movements; new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts, mood, or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Zolpidem should only be taken at bedtime. If you did not take zolpidem at bedtime and you are unable to fall asleep, you may take zolpidem if you will be able to remain in bed for 7-8 hours afterward. Do not take zolpidem if you are not ready to go to sleep right away and stay asleep for at least 7-8 hours.

Side effects

Mild side effects

Zolpidem may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• weakness
• headache
• dizziness
• 'drugged feeling'
• unsteady walking
• difficulty keeping balance
• constipation
• diarrhea
• gas
• heartburn
• stomach pain or tenderness
• changes in appetite
• uncontrollable shaking of a part of the body
• burning or tingling in the hands, arms, feet, or legs
• unusual dreams
• dry mouth or throat
• ringing, pain, or itching in the ears
• eye redness
• muscle aches or cramps
• joint, back, or neck pain
• heavy menstrual bleeding

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• rash
• hives
• itching
• swelling of the eyes, face, lips, tongue, or throat
• feeling that the throat is closing
• difficulty breathing or swallowing
• hoarseness
• shortness of breath
• nausea
• vomiting
• pounding heartbeat
• chest pain
• blurred vision or other vision problems

Zolpidem may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• coma (loss of consciousness for a period of time)
• slowed breathing or heartbeat

What other information should I know

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist if you have any questions about refilling your prescription.

Brand names

• Ambien®
• Ambien CR®