zolpidem (Ambien)

• Zolpidem belongs to a class of drugs called sedatives or hypnotics. Zolpidem shares some characteristics of a family of sedatives called benzodiazepines. Benzodiazepines cause sedation, muscle relaxation, act as anti-convulsants (anti-seizure medications), and reduce anxiety. Zolpidem has selectivity in that it has little of the muscle relaxant and anti-seizure effects and more of the sedative effect. Therefore, it is used primarily as a medication for sleep. The oral spray form of zolpidem, Zolpimist, has more rapid absorption than the tablet form because it is absorbed through the lining of the mouth.

The FDA approved zolpidem in December 1992.

Ambien, Ambien CR, Intermezzo, Zolpimist, Edluar

GENERIC AVAILABLE: Yes

Yes

• Zolpidem is used for treating insomnia.
• Conventional tablets are used for short-term treatment of insomnia associated with difficulty falling asleep.
• Long acting tablets are used for treating insomnia associated with difficulty falling asleep or staying asleep.
• Zolpidem improves initiation of sleep and keeps patients asleep longer.

The most common side effects of zolpidem are:

• Drowsiness
• Headache
• Weakness
• Dizziness
• A "drugged" feeling, which probably reflect the action of the drug

Other side effects include:

• Confusion
• Insomnia
• Diarrhea
• Depression
• Dry mouth
• Rash
• Euphoria
• Ataxia (balance problems), and
• Visual changes.

Zolpidem can cause withdrawal symptoms (muscle cramps, sweats, shaking, and seizures) when the drug is abruptly discontinued. Zolpidem can cause abnormal behavior with confusion, paradoxical insomnia or "complex sleep-related behaviors," which may include sleep-driving (driving with no memory of having done so). If these side effects occur, zolpidem should be discontinued.

• The recommended adult dose of zolpidem conventional tablets or spray is 5 mg for females, the elderly, or fragile individuals, and 5 to 10 mg for males.
• The maximum dose is 10 mg daily.
• For females and the elderly, give 6.25 mg of extended-release tablets; and males should receive 6.25 to 12.5 mg.
• The maximum dose of extended-release tablets is 12.5 mg daily.
• Elderly patients have decreased ability to eliminate zolpidem from the body, and accumulating zolpidem may cause side effects.

• Alcohol has an additive effect with zolpidem and the two should not be combined. Zolpidem should not be combined with other sedative drugs because of the additive effects.
• Itraconazole (Sporanox) and ketoconazole (Nizoral, Extina, Xolegel, Kuric) may increase the blood concentration of zolpidem by reducing the activity of the enzymes that breakdown zolpidem in the liver. Conversely, rifampin may reduce the concentration of zolpidem by increasing the activity of the enzymes that breakdown zolpidem.

• There are no adequate studies of zolpidem use in pregnant women.
• Zolpidem is excreted in human breast milk and may adversely affect the infant.

What preparations of zolpidem are available?

• Tablets: 5 and 10 mg.
• Tablet (extended release): 6.25 mg and 12.5 mg.
• Oral spray: 5 mg/spray

How should I keep zolpidem stored?

Zolpidem should be stored at room temperature, 20-25 C (68-77 F), in an air-tight container.