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Zolpidem extended-release tablets

What is this medicine?

ZOLPIDEM (zole PI dem) is used to treat insomnia. This medicine helps you to fall asleep and sleep through the night.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, split, or chew the tablet before swallowing. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to gradually reduce the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in vision

  • confusion

  • depressed mood or other changes in moods or emotions

  • feeling faint or lightheaded, falls

  • hallucinations

  • loss of balance or coordination

  • loss of memory

  • restlessness, excitability, or feelings of anxiety or agitation

  • suicidal thoughts

  • unusual activities while asleep like driving, eating, making phone calls, or sexual activity

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • dizziness

  • drowsiness the day after you take this medicine

  • headache

What may interact with this medicine?

  • alcohol

  • antihistamines for allergy, cough and cold

  • certain medicines for anxiety or sleep

  • certain medicines for depression, like amitriptyline, fluoxetine, sertraline

  • certain medicines for fungal infections like ketoconazole and itraconazole

  • certain medicines for seizures like phenobarbital, primidone

  • ciprofloxacin

  • dietary supplements for sleep, like valerian or kava kava

  • general anesthetics like halothane, isoflurane, methoxyflurane, propofol

  • local anesthetics like lidocaine, pramoxine, tetracaine

  • medicines that relax muscles for surgery

  • narcotic medicines for pain

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

  • rifampin

What if I miss a dose?

This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at controlled room temperature between 15 and 25 degrees C (59 and 77 degrees F).

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • depression

  • history of drug abuse or addiction

  • if you often drink alcohol

  • liver disease

  • lung or breathing disease

  • myasthenia gravis

  • sleep apnea

  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

  • an unusual or allergic reaction to zolpidem, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medicines are used every night for more than a few weeks, they may stop working. Talk to your doctor if your insomnia worsens or is not better within 7 to 10 days.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep since your risk of doing these sleep-related activities will be increased.

Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. Do not drive, use machinery, or do anything that needs mental alertness the day after you take this medicine. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your moods or behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider. Copyright© 2016 Gold Standard
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