Zaleplon (Sonata®): Basic Information - Simple and Practical Mental Health

Zaleplon (Sonata® and generic) is a hypnotic with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs. Here is basic information about this medication.

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 sleep-walking, 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

Please refer to Prescribing Information (see link below) for a complete discussion of dosage, administration, warnings and precautions, contraindications, etc.

Practical tips on using hypnotics: the Z drugs

Practical tips on using hypnotics: benzodiazepines

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Three important pieces of information about benzodiazepines

Sleep Hygiene worksheets-Part 1 and Part 2

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

References

Zaleplon (Sonata®) Prescribing Information

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