zaleplon

Zaleplon is a hypnotic (a medication that induces sleep) that is used for treating insomnia. It is chemically unrelated to the benzodiazepine class of medications for sleep, for example, lorazepam (Ativan), oxazepam (Serax), flurazepam (Dalmane), triazolam (Halcion), and temazepam (Restoril), but it has similar effects because it attaches to the same receptors on nerve cells as these well-known medications. It was approved by the FDA in 1999.

Sonata

GENERIC AVAILABLE: Yes

Yes

Zaleplon is used for the short-term treatment of insomnia. It decreases the time to the onset of sleep and was used for up to 5-weeks in clinical trials. It does not increase total sleep time or decrease the number of awakenings.

The most common side effects associated with zaleplon are:

• headache,
• drowsiness,
• dizziness,
• amnesia,
• stomach ache, and
• muscle pain.

Studies have shown that zaleplon has a potential for abuse similar to benzodiazepines. Patients may experience rebound insomnia on the first night after stopping zaleplon. Zaleplon can cause abnormal behavior or thinking or "complex sleep-related behaviors," which may include sleep-driving (driving with no memory of having done so). If these side effects occur, zaleplon should be discontinued.

PREPARATIONS: Capsules: 5 and 10 mg

The recommended dose is 5 to 20 mg at bedtime for assistance in falling asleep. Because of its short duration of activity, it is not effective for persons who wake up during the night. Zaleplon should be taken immediately before bedtime or after going to bed and experiencing difficulty falling asleep. Taking zaleplon with a high-fat meal slows its absorption and may also slow its onset of action.

Rifampin reduces the amount of zaleplon in the blood by more than 80%. This could lead to a decrease in zaleplon's activity. Cimetidine (Tagamet) can increase the amount of zaleplon in the blood by 85% by reducing the breakdown of zaleplon in the liver. If cimetidine must be used, lower doses of zaleplon are suggested. Ketoconazole (Nizoral, Extina, Xolegel, Kuric), erythromycin and similar drugs that reduce breakdown of drugs in the liver also increase blood concentrations of zaleplon. The drowsiness that can occur with zaleplon is accentuated by alcohol, and, therefore, patients taking zaleplon should not drink alcoholic beverages. Imipramine (Tofranil, Tofranil-PM) and thioridazine also increase drowsiness when combined with zaleplon.

There are no studies of zaleplon in pregnant women. In studies in rats, damage to fetuses were reported. Therefore, zaleplon is not recommended for pregnant women unless the physician feels the benefits outweigh the potential risks.

A small amount of zaleplon is excreted in breast milk. Because the effects of zaleplon on nursing infants are unknown, it is recommended that nursing mothers not take zaleplon.

How should I keep zaleplon stored?

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