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.
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.
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.
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.
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.