PREGNANCY AND BREASTFEEDING SAFETY: 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.
DOSING: 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.
STORAGE: Capsules should be stored at room temperature, between 20 C - 25 C (68 F - 77 F).
DRUG CLASS AND MECHANISM: 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.
Medically reviewed by Eni Williams, PharmD
Reference: FDA Prescribing Information
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