Zaleplon

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Christina Bookwalter PharmD, MS MEd, BCPS, BCACP
Updated on October 25, 2023

Zaleplon (ZAL e plon) is a generic medication prescribed for insomnia (difficulty sleeping). Zaleplon belongs to a group of drugs called sedative-hypnotics.

Boxed warning: Risk of unusual sleep behaviors

Zaleplon has a boxed warning about the risk of unusual sleep behaviors. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for zaleplon” section.

Common questions about zaleplon

Below you’ll find answers to a few commonly asked questions about zaleplon.

What brand names are available for zaleplon?

Zaleplon is a generic medication. Sonata is the brand-name version of this drug.

A generic medication is an identical copy of the active drug in a brand-name medication. An active drug is the ingredient that makes a medication work. Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less compared to brand-name drugs.

Talk with your doctor or pharmacist to learn more about Sonata or zaleplon.

Is zaleplon similar to zolpidem or eszopiclone?

Yes, zolpidem (Ambien, Edluar) and eszopiclone (Lunesta) are similar to zaleplon. Each is approved by the Food and Drug Administration (FDA) to treat insomnia (difficulty sleeping). Zaleplon is also similar to another drug called zopiclone. But zopiclone isn’t available in the United States.

Zaleplon starts working more quickly than zolpidem and eszopiclone. It also wears off more quickly. So doctors may prescribe zaleplon for trouble falling asleep. But they may recommend a different treatment option for difficulty staying asleep.

Talk with your doctor or pharmacist to find out whether one of these medications may be an option for your insomnia.

How does zaleplon work? And how long does it take to start working?

Zaleplon treats insomnia by helping you fall asleep. It works by boosting the activity of gamma-aminobutyric acid (GABA). This is a brain chemical that’s thought to have calming effects.

Zaleplon starts working soon after you take a dose and reaches its maximum effect within 1 hour. Because the drug works quickly, you should take it right before bedtime or if you’re already in bed but can’t fall asleep. The drug might take longer to start working if you take it after consuming a high fat meal.

If you’d like to know more about how zaleplon works, talk with your doctor or pharmacist.

Is misuse, withdrawal, or dependence possible with zaleplon?

Yes, these are possible. Zaleplon is a controlled substance because taking it can lead to misuse or dependence. Due to these risks, the government regulates controlled substances.

With misuse, a drug is taken in a way other than how it’s prescribed. With dependence, your body needs the drug to function like usual.

If you take zaleplon every night, especially long term, your body can become dependent on it. When you abruptly stop taking it, you may develop withdrawal. This causes uncomfortable symptoms that occur after you stop taking a drug that your body is used to having.

Because of these risks, your doctor will likely prescribe zaleplon as a short-term treatment. Or they may recommend only taking zaleplon once in a while, as needed.

If you have more questions or any concerns about misuse, withdrawal, or dependence, talk with your doctor.

Side effects of zaleplon

Zaleplon may cause mild or serious side effects. More common mild side effects of zaleplon and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about zaleplon’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for zaleplon listed in the “Resources” section.

Mild side effects

More common mild side effects of zaleplon are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about zaleplon’s side effects, refer to the prescribing information for zaleplon listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Zaleplon oral capsule’s mild side effects include:

• headache
• dizziness
• difficulty with balance or coordination
• dry mouth
• mild allergic reaction*

Serious side effects

Serious side effects of zaleplon are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about zaleplon’s side effects, refer to the prescribing information for zaleplon listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, zaleplon’s serious side effects include: 

• memory problems
• reduced mental alertness the day after taking zaleplon, which may affect your ability to drive or perform other activities that require concentration
• suicidal thoughts or behaviors
• boxed warning: risk of unusual sleep behaviors*
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for zaleplon” section.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Textline at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

Uses of zaleplon

The Food and Drug Administration (FDA) approves prescription drugs such as zaleplon for certain conditions. Approved uses for zaleplon are described below.

Use for insomnia

Doctors may prescribe zaleplon oral capsule for treating insomnia (difficulty sleeping). It’s used for this purpose in adults. It’s usually prescribed as a short-term treatment.

Specifically, zaleplon is prescribed to treat insomnia in people who have difficulty falling asleep. The drug works to reduce sleep onset (how long it takes to fall asleep).

Zaleplon can help you fall asleep sooner, but it may not help you stay asleep longer or reduce middle-of-the-night awakenings.

Interactions and warnings for zaleplon

Below you’ll find information about zaleplon’s possible interactions and warnings.

Interactions of zaleplon

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take zaleplon, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs 
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for zaleplon” section below.

Warnings for zaleplon

Some people should not take zaleplon, and others should take it cautiously.

Boxed warning: Risk of unusual sleep behaviors

Zaleplon has a boxed warning about the risk of unusual sleep behaviors. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

With unusual sleep behaviors, people perform activities without being fully awake. These activities may lead to harm to themselves or others. Examples include:

• sleepwalking
• cooking and eating meals
• driving

Sleepwalking was reported in zaleplon’s studies, but it wasn’t a common side effect. Other unusual sleep behaviors have been reported with drugs that are similar to zaleplon. In rare cases, these side effects have resulted in serious injuries or even death.

If you have unusual sleep behaviors, or if people close to you notice these behaviors, tell your doctor. They’ll have you stop taking zaleplon. They may recommend other ways to treat your condition.

To learn more, talk with your doctor or pharmacist.

Other warnings

Zaleplon could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether zaleplon is a safe option for you.

Ask your doctor about specific warnings for zaleplon, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Zaleplon can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to zaleplon or any of its ingredients, your doctor will likely not prescribe zaleplon. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to zaleplon, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of zaleplon

You should not take more zaleplon than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much zaleplon, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and zaleplon

Information about zaleplon and pregnancy and breastfeeding is described below.

Zaleplon and pregnancy

It’s not known whether zaleplon should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Zaleplon and breastfeeding

It’s not known whether zaleplon should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

What to ask your doctor

Let your doctor know if you have questions about zaleplon or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• Can zaleplon cause weight gain?
• What are the risks of taking zaleplon every night?
• What lifestyle changes would be helpful for my condition?
• If I take zaleplon as needed, is it safe for me to continue taking my other medications and supplements?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Gunja N. (2013). The clinical and forensic toxicology of Z-drugs. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3657020/
• Zaleplon capsules USP CIV. (2021). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/9c83b71e-8344-4c77-b7f6-a9c862f9e7dd/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.