Ambien

(Zolpidem Tartrate)

The active ingredient in Ambien is zolpidem tartrate. It works on gamma-aminobutyric acid (GABA) A receptor in the brain to reduce brain activity allowing you to relax and fall asleep quickly.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Ambien. However, the following is a synopsis of the general guidelines for the use of Ambien:

• Ambien doses differ between men and women, and it is not recommended for children. The dose is typically lower in older adults as its effects can be stronger.
• Read all of the directions and consult your healthcare provider if you have any questions.
• Ambien is a controlled substance and can be habit-forming. Overuse can result in addiction, overdose, or death.
• Only use Ambien if you plan to get at least 7-8 hours of sleep before becoming active.
• Ambien is intended for short-term treatment; if sleeplessness persists beyond 7-10 days, see your doctor.
• Do not take Ambien for longer than 4-5 weeks without medical advice.
• Stopping Ambien abruptly after long-term use can produce withdrawal symptoms.
• If your insomnia worsens after you stop taking Ambien, contact your doctor.
• Swallow Ambien CR tablets whole, without crushing, chewing, or breaking them.

The most common side effects of Ambien seen in clinical trials as compared to placebo include:

• Headache or nausea.
• Sleepiness, feeling tired, or loss of energy.
• Drowsiness, lightheadedness or dizziness.
• Diarrhea or constipation.
• Dry mouth.
• Flu-like symptoms.
• Abnormal dreams or memory loss.
• Depression.

Some individuals may experience serious side effects while using Ambien. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Behavioral changes: anxiety, nervousness, confusion, hallucinations, and suicidal thoughts or actions.
• Trouble breathing (respiratory depression): shortness of breath or breathing problems.
• Concerning sleep behaviors: sleepwalking, sleep driving, sleep apnea, or any type of activity without being alert.
• Slower brain activity (CNS depression): confusion or coma.
• Allergic reaction: hives, shortness of breath, chest pain or tightness, swelling of your tongue, face, or throat.

These are not all of the possible side effects of Ambien. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Ambien, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Ambien should not be used if you are allergic to zolpidem or lactose, as some tablets may contain both.
• Avoid sharing Ambien with others, and never go above the recommended dose or duration.
• This medication is not recommended for young people under the age of 18, and the dosage varies between men and women.
• Ambien may impair thoughts or reactions; wait at least 4 hours or until completely awake before engaging in tasks that need attention.
• Avoid using Ambien if you drink alcohol during the day or immediately before going to bed.
• Myasthenia gravis, which is a condition that causes weakness of certain muscles.
• Inform your healthcare provider if you have a history of mental illness, worsening depression, history of drug addiction, lung disease, sleep apnea, are taking antidepressants, or liver/kidney disease to confirm that this is safe for you.
• Next-day drowsiness - the morning after you take Ambien you may feel drowsy or dizzy.

Boxed Warning

• Some users may engage in activities such as driving, eating, making phone calls, or walking without recalling them. Some of these can lead to serious injury or even death. If this happens, discontinue use and visit your doctor.

Contraindications are health conditions or situations where taking a medication could be unsafe. Let your healthcare provider know if you have experienced unusual behaviors like sleepwalking, sleep driving, or sleep eating after taking zolpidem, as it may not be safe for you to use this medication.

Ambien can begin to act within 15-30 minutes. If you are still having difficulties falling or staying asleep after 7 to 10 days of taking the drug as directed, contact your healthcare professional. You may have another health condition that is causing your insomnia.

When Ambien is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions.

• Combining Ambien with other drowsiness-inducing medicines can cause excessive sedation. Consult your healthcare provider before taking an opioid, another sleeping pill, a muscle relaxant, or medication for anxiety (benzodiazepine) or seizures as well as St. John’s Wort.
• This is not an exhaustive list of probable interactions. Tell your doctor about all of your current medications, as well as any new ones you start or stop taking.

Insomnia

For insomnia, the typical nightly dose of zolpidem depends on the form of the medication:

Immediate-release tablet: 5 mg to 10 mg taken by mouth at bedtime.

Immediate-release capsule: 7.5 mg taken by mouth at bedtime.

Extended-release tablet (Ambien CR): 6.25 mg to 12.5 mg taken by mouth at bedtime.

Sublingual tablet (Edluar): 5 mg to 10 mg placed under the tongue at bedtime.

Store in a cool, dry place, at room temperature and out of reach of children.

Cosette Pharmaceuticals is the current manufacturer of Ambien.

There are several lower-cost generic versions of Ambien available with the active ingredient of zolpidem tartrate. Other treatment options/sleep medicines include Lunesta (eszopiclone).

If you stop Ambien abruptly, you may experience symptoms such as sweating, shakiness, unpleasant feeling, or stomach and muscle cramps. You should work with your healthcare provider to slowly come off of Ambien to help avoid these adverse effects.

It is not clear whether Ambien is safe during pregnancy. However, zolpidem might cross the placenta and produce significant side effects in your unborn baby (e.g., difficulty breathing, extreme tiredness), particularly if taken during the third trimester of pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Ambien may pass into breast milk, causing excessive sleepiness in your breastfed baby. If you need to continue breastfeeding, you can consider pumping and discarding the breast milk for 23 hours after taking Ambien to reduce the risk of these side effects. It is expected that after 23 hours, the breast milk will contain less medicine. Consult your healthcare provider about the best approach to breastfeeding while on the drug.