Zaleplon Dosage

Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.

Applies to the following strengths: 5 mg; 10 mg

Usual Adult Dose for Insomnia

10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

Maximum dose: 20 mg/day

Comments:

Doses should be individualized.
Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Usual Geriatric Dose for Insomnia

5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

Maximum dose: 10 mg/day

Comments:

Doses should be individualized.
Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Renal Dose Adjustments

Mild to Moderate Renal Dysfunction: No adjustment recommended.
Severe Renal Dysfunction: Data not available

Liver Dose Adjustments

Mild to Moderate Liver Dysfunction: 5 mg orally once a day immediately before bedtime OR after going to bed and having trouble falling asleep
Severe Liver Dysfunction: Not recommended.

Dose Adjustments

Debilitated Patients and/or Low Weight Patients: 5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

Maximum dose: 10 mg/day

Comments:

Doses should be individualized.
Efficacy was established in trials ranging from a single night to 5 weeks.

Concomitant Use with Cimetidine:

Initial dose: 5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

Patients with Compromised Respiration Due to Preexisting Conditions: Frequent monitoring recommended.

Patients with Concomitant Illness(es): Use with caution in disease states or with the concomitant use of drugs that could affect metabolism or hemodynamic response.

Precautions

CONTRAINDICATIONS:

Hypersensitivity to the active component or to any of the ingredients
Patients who have previously experienced an episode of complex sleep behaviors after taking this drug

US BOXED WARNINGS:
COMPLEX SLEEP BEHAVIORS:

Complex sleep behaviors including sleepwalking, sleep-driving, and engaging in other activities while not fully awake may occur following the use of this drug.
Some of these events may result in serious injuries, including death.

Recommendation:

Discontinue this drug immediately if the patient experiences a complex sleep behavior.

Safety and efficacy have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

This drug should be taken immediately prior to bedtime or after the patient has gone to bed and is having trouble falling asleep.
Patients should avoid taking this drug with/immediately after consuming a heavy, high-fat meal, as slower absorption may reduce the effect of this drug on sleep latency.

Storage requirements:

Protect from light.

General:

In clinical trials, this drug decreased the time to sleep onset for up to 30 days; however, it was not shown to increase the total sleep time or decrease the number of awakenings.

Monitoring:

NERVOUS SYSTEM: Changes in cognitive function, including complex behaviors
PSYCHIATRIC: New/worsening depression
RESPIRATORY: Respiratory function in patients with compromised respiratory function

Patient advice:

Patients should be instructed to immediately report "sleep driving," other complex behaviors, and any new/worsening signs/symptoms of depression.
Inform patients that this drug may cause blurred vision, dizziness, impaired coordination, short-term memory impairment, and/or somnolence, and they should avoid driving or operating machinery if these side effects occur.
Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.