Intermezzo (zolpidem)

Intermezzo contains a low dose of zolpidem, the same active ingredient in Ambien. Zolpidem belongs to a class of drugs called sedatives or hypnotics. Zolpidem shares some characteristics of a family of sedatives called benzodiazepines which includes diazepam (Valium). Benzodiazepines cause sedation, muscle relaxation, act as anticonvulsants (antiseizure medications), and reduce anxiety.

Zolpidem has selectivity in that it has little of the muscle relaxant and antiseizure effects and more of the sedative effect. Therefore, it is used primarily as a medication for sleep.

The FDA approved Intermezzo in November 2011. The first formulation of zolpidem (Ambien) was approved in 1992.

What brand names are available for Intermezzo?

Intermezzo

Is Intermezzo available as a generic drug?

No

Do I need a prescription for Intermezzo?

Yes

The most common side effects of zolpidem are:

• headache,
• nausea,
• drowsiness,
• dizziness, and
• diarrhea.

Other important side effects include:

• confusion,
• insomnia,
• euphoria,
• ataxia (balance problems), and
• visual changes.

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. Zolpidem is a controlled substance because it is likely to be abused and may cause dependence.

The recommended dose is 1.75 mg for women and 3.5 mg for men once per night when a patient wakes up in the middle of the night and has difficulty falling back to sleep. Tablets should be placed under the tongue and allowed to dissolve completely before swallowing. Tablets should not be swallowed whole. The action of Intermezzo may be delayed by food if food is consumed with or immediately prior to administration of Intermezzo.

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.

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

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

How should I keep Intermezzo stored?

Intermezzo should be stored at room temperature, 20 C - 25 C (68 F - 77 F).