Ambien

Ambien (Stilnox, Zolpidem) is in a class of drugs called sedative/hypnotics or sleep medicines. Stilnox (the brandname used for Ambien outside the US) affects chemicals in your brain that may become unbalanced and cause insomnia. Ambien (Stilnox, Zolpidem) induces sleep and causes relaxation. It is used to treat sleep disorders such as trouble falling asleep, waking up many times during the night, or waking up too early in the morning. Ambien sleeping pill (Stilnox, Zolpidem) is for short-term use only - usually 7 to 10 days. Longer-term use must be monitored closely by a doctor.

Stilnox® is available in more than 90 countries, including the United States where it is marketed under the name Ambien. This sleep medicine was launched in Japan, in December 2000, under the name Myslee. It is already the second-ranking product on the Japanese hypnotics market in terms of sales.

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

Discuss with your healthcare provider

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of Ambien may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Ambien.

Do not give this medicine to anyone younger than 18 years of age.

Instructions

Know the different dosages of Ambien. Ambien is available in three different dosages by prescription. There are 5-mg. pink capsules, 10-mg. white capsules and 6.25-mg. round, pink time-release tablets.

Take Ambien exactly as prescribed by your doctor. Follow the directions on the label of your prescription bottle. Do not take more Ambien than you are prescribed or take Ambien longer than your doctor tells you to.

Recommended dosage

ADULTS

The recommended dosage for adults is 10 milligrams right before bedtime. Your doctor will prescribe a smaller dose if you are likely to be sensitive to the drug or have a liver problem. Never take more than 10 milligrams of Ambien per day.

CHILDREN

Safety and effectiveness have not been established in children below the age of 18.

OLDER ADULTS

Because older people and those in a weakened condition may be more sensitive to Ambien's effects, the recommended starting dosage is 5 milligrams just before bedtime.

What other drugs will affect Ambien?

Before taking Ambien, tell your doctor if you are using any of the following drugs:

• itraconazole (Sporanox);
• rifampin (Rifadin, Rimactane, Rifater);
• antidepressants such as imipramine (Janimine, Tofranil), fluoxetine (Prozac, Sarafem), or sertraline (Zoloft); or
• narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications.

If you are using any of these drugs, you may not be able to use this medication, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Ambien. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Ambien - Side Effects

A single-dose interaction study with zolpidem 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the zolpidem half-life. There was no evidence of an additive effect in psychomotor performance.

Following five consecutive nightly doses of zolpidem 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem Cmax was significantly higher (43%) and Tmax was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem.