zolpidem, Ambien, Ambien CR, Zolpimist, Edluar, Tovalt ODT (discontinued)

Pharmacy Author:
Medical and Pharmacy Editor:

GENERIC NAME: zolpidem

BRAND NAME: Ambien, Ambien CR, Zolpimist, Edluar, Tovalt ODT (discontinued)

DRUG CLASS AND MECHANISM: 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.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

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

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

PRESCRIBED FOR: 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.

DOSING: The recommended adult dose of zolpidem is 10 mg as conventional tablets or spray or 12.5 mg as extended-release tablets. In elderly patients, an initial dose of 5 mg as conventional tablets or 6.25 mg as extended-release tablets is recommended because elderly patients have decreased ability to eliminate zolpidem from the body, and accumulating zolpidem may cause side effects.

DRUG INTERACTIONS: 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 of the enzymes that breakdown zolpidem.

PREGNANCY: There are no adequate studies of zolpidem use in pregnant women.

NURSING MOTHERS: Zolpidem is excreted in human breast milk and may adversely affect the infant.

SIDE EFFECTS: The most common side effects of zolpidem are drowsiness, dizziness, and a "drugged" feeling, which probably reflect the action of the drug. Other side effects include confusion, insomnia, 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.

REFERENCES:

FDA Prescribing Information for zolpidem

AHFS Drug Information for zolpidem


Last Editorial Review: 6/15/2010




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