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What is Ambien?

Ambien is a sedative, also called a hypnotic. Zolpidem affects chemicals in the brain that may be unbalanced in people with sleep problems insomnia).

Ambien is used to treat insomnia. The immediate-release tablet is used to help you fall asleep when you first go to bed. The extended-release form, Ambien CR, has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

 

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AMBIEN contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration.

Each AMBIEN tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.

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DOSAGE AND ADMINISTRATION

 

Dosage In Adults

Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS]. The total dose of AMBIEN should not exceed 10 mg once daily immediately before bedtime. AMBIEN should be taken as a single dose and should not be readministered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

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Is Ambien a controlled substance?

Yes, Ambien (zolpidem) is a Schedule 4 controlled substance. This means it has a lower potential for abuse relative to Schedule 3 controlled substances. Abuse may lead to limited physical dependence or psychological dependence less than those in Schedule 3.  Ambien has a currently accepted medical use in the United States. There may be variations in CSA schedules between individual states.

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Warnings

Ambien may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share Ambien with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take Ambien in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

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Before taking this medicine

Some people using Ambien have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking this medicine and talk with your doctor about another treatment for your sleep disorder.

You should not use Ambien if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

Ambien is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • depression, mental illness, or suicidal thoughts;
  • drug or alcohol addiction;
  • lung disease or breathing problems;
  • sleep apnea (breathing stops during sleep); or
  • liver or kidney disease.

Taking Ambien in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.

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How should I take Ambien?

Take Ambien exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.

The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of Ambien are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Never take this medicine if you do not have a full 7 to 8 hours to sleep before being active again.

Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take this medicine for longer than 4 or 5 weeks without your doctor's advice.

Do not stop using Ambien suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking Ambien, and may be even worse than before. Call your doctor if you still have worsened insomnia for the first few nights after you stop taking this medicine.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.

Store at room temperature away from moisture and heat. Do not freeze.

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What happens if I miss a dose?

Since Ambien is taken only at bedtime if needed, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What to avoid

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy the morning after taking Ambien, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

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Ambien side effects

Zolpidem may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using this medicine and call your doctor at once if you have:

  • chest pain, fast or irregular heartbeat, feeling short of breath;
  • trouble breathing or swallowing; or
  • feeling like you might pass out.

The sedative effect of Ambien may be stronger in older adults.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common Ambien side effects may include:

  • daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
  • tired feeling, loss of coordination;
  • stuffy nose, dry mouth, nose or throat irritation;
  • nausea, constipation, diarrhea, upset stomach; or
  • headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Ambien?

Using Ambien with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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