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Zaleplon (Sonata®): Basic Information for Prescribers

Zaleplon (Sonata® and generic) is a hypnotic with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs.

On this page, we will provide basic information about this medication. Links to other articles on this website with more advanced information and tips related to this medication and related topics are provided below, under the “Related Pages” section.


FDA-approved indications

Short-term treatment of insomnia (decreases sleep latency).


Pharmacokinetics

Zaleplon is primarily metabolized by aldehyde oxidase and, to a lesser extent, by cytochrome P450 3A4 (Prescribing Information). All of its metabolites are pharmacologically inactive (Prescribing Information).


Contraindications

Zaleplon (Sonata®) is contraindicated in:

1. Patients who have experienced complex sleep behaviors after taking zaleplon.

2. Patients with hypersensitivity to zaleplon or any excipients in the pills.


Warnings and Precautions

The boxed warning (so-called “black box warning”) for zaleplon (Sonata®) states (Prescribing Information):

WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors, including sleepwalking, sleep-driving, and engaging in other activities while not fully awake, may occur following use of Sonata. Some of these events may result in serious injuries, including death. Discontinue Sonata immediately if a patient experiences a complex sleep behavior

Please see THIS PAGE for a patient handout from the Prescribing Information about possible complex sleep behaviors related to zaleplon (Sonata®). Here is a link to the Medication guide for zaleplon (Sonata®) that should be provided to patients:


Potential side effects

Please see THIS PAGE for a handout listing both the common and less common side effects of this medication, along with the percentages of patients who report them.


Dosage and administration

Initial dose: 10 mg once daily at bedtime OR after going to sleep if having trouble going to sleep

Maximum dose: 20 mg once daily at bedtime

Special considerations

a) Low weight: 5 mg once daily at bedtime

b) Elderly or debilitated: Recommended dose 5 mg, maximum dose 10 mg

c) Mild to moderate hepatic impairment: 5 mg once daily at bedtime

d) Severe hepatic impairment: Not recommended


Dosage forms and strengths

Capsules: 5 mg, 10 mg


Important! This page does not provide all the information needed to prescribe this medication. Please refer to the full Prescribing Information (see link below) before prescribing this medication.


Related Pages

Z Drugs

Practical tips on using hypnotics: the Z drugs

How to match the patient with the right Z-drug

Give all these instructions while prescribing zolpidem

Are the Z-drugs (zolpidem and others) safe to take during pregnancy?

Hypnotic if waking up in the middle of the night?

Eszopiclone (Lunesta®): Basic Information

Zolpidem (Ambien® and Ambien CR®): Basic Information

Zaleplon (Sonata®): Basic Information


Non-Medication Interventions for Insomnia

Relaxation Practice: A Simple and Powerful Tool for Anxiety, Tension, and Insomnia

Sleep masks for better sleep

Blue-light-blocking glasses

Sleep Hygiene Worksheets-Part 1 and Part 2

Sleep log: Ten important questions about the person’s sleep


References

Zaleplon (Sonata®) Prescribing Information. Available at this link.


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Disclaimer: The material on this website is provided as general education for medical professionals. It is not intended for patients or other laypersons, nor is it a substitute for medical advice, diagnosis, or treatment. Patients must always consult a qualified healthcare professional regarding their diagnosis and treatment. Healthcare professionals should always check this website for the most up-to-date information.

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