Zaleplon 1058
Photo by: Sebastian Kaulitzki


Zaleplon is classified as a hypnotic drug. These drugs help people sleep. Zaleplon is available in the United States as the brand name drug Sonata.


Zaleplon is a drug that is used to treat short-term insomnia , and it can be habit-forming.


The United States Food and Drug Administration approved Zaleplon in 1999 to treat short-term problems sleeping. Zaleplon is thought to act by mimicking a chemical in the brain that helps to facilitate sleep. It is different from other sleeping pills, because it begins to work almost immediately and its effects are rather short-lived (a few hours). These properties make it beneficial both for people who have troubling falling asleep at bedtime and for people who awaken in the middle of the night and have trouble falling back to sleep. Zaleplon may be taken in the middle of the night so long as the person can sleep at least four more hours before having to awaken.

Zaleplon is available as capsules. The drug is broken down by the liver. It is a controlled substance and can be habit-forming.

Recommended dosage

The usual dose of zaleplon for adults is 5–20 mg. For healthy adults, 10 mg is a common dosage. However, people over age 65, small adults with low body weight, and people with serious health problems (especially liver disease) should take a dose at the low end of this range (usually 5 mg). Zaleplon is taken immediately before bedtime. It usually takes only about 30 minutes for the sleep-inducing actions of zaleplon to be felt, and sleep-facilitating effects appear to last only a few hours. If zaleplon is taken with a meal, it will take longer to work. For the fastest sleep onset, it should be taken on an empty stomach. The maximum dose for one day is 20 mg. Under no circumstances should a person take more than 20 mg in one day.


Zaleplon can be habit-forming and should be taken exactly as directed by a physician. A person who forgets a dose of zaleplon should skip the dose and take the next dose at the regularly scheduled time.

Because zaleplon is used to help people fall asleep, it should not be used with other drugs (over-the-counter or prescription) that also cause drowsiness. Zaleplon should be used only with close physician supervision in people with liver disease and in the elderly, because these individuals are especially sensitive to the sedative properties of zaleplon. Zaleplon should not be used before driving, operating machinery, or performing activities that require mental alertness. People with a history of drug abuse, psychiatric disorders, or depression should be carefully monitored when using zaleplon since zaleplon may worsen symptoms of some psychiatric disorders and can become a drug of abuse.

If zaleplon is needed for more than seven to ten days, patients should be re-evaluated by a physician to determine if another disorder is causing their difficulty sleeping. When zaleplon or other sleeping pills are used every night for more than a few weeks, they begin to lose their effectiveness and/or people may become dependent upon them to fall asleep. Zaleplon can be addictive. People using zaleplon should not stop taking the drug suddenly because withdrawal symptoms, including sleep disturbances, may occur even if zaleplon has been used only for a short time.

Side effects

Some sleeping pills such as zaleplon can cause aggressiveness, agitation, hallucinations , and amnesia (memory problems). A patient experiencing these side effects should call a physician immediately. A physician should also be called immediately if a person taking zaleplon develops a fast or irregular heartbeat, chest pains, skin rash, or itching.

The most common side effects of zaleplon are less serious and include dizziness, drowsiness, impaired coordination, upset stomach, nausea, headache, dry mouth, and muscle aches. Other side effects that may occur include: fever, amnesia, tremor, or eye pain. Many side effects appear worse at higher doses, so it is important to use the lowest dose that will induce sleep.


Any drug that causes drowsiness may lead to substantially decreased mental alertness and impaired motor skills when taken with zaleplon. Some examples include alcohol, antidepressants such as imipramine or paroxetine , antipsychotics like thioridazine , and some antihistamines.

Because zaleplon is broken down by the liver, it may interact with other drugs broken down by the liver. For example, the drug rifampin, which is used to treat tuberculosis, may cause zaleplon to be less effective. Alternatively, cimetidine (Tagamet), a drug commonly used to treat heartburn, may cause people to be more sensitive to zaleplon.



Facts and Comparisons Staff. Drug Facts and Comparisons. 6th Edition. St. Louis: A Wolter Kluwer Company, 2002.

Wyeth Laboratories Staff. Sonata Package Insert. Philadelphia: A Wyeth-Ayerst Company, 1999.

Kelly Karpa, RPh, PhD

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