From the Guidelines
The maximum recommended dose of zaleplon is 20 mg per day, taken immediately before bedtime. This medication is a non-benzodiazepine sedative-hypnotic used for the short-term treatment of insomnia. The typical starting dose is 10 mg for most adults, but this can be increased to 20 mg if needed for effectiveness, as indicated in the clinical guideline for the evaluation and management of chronic insomnia in adults 1. For elderly patients or those with hepatic impairment, a lower starting dose of 5 mg is recommended, with a maximum of 10 mg. Zaleplon has a very short half-life of about 1 hour, which makes it particularly useful for sleep initiation problems rather than sleep maintenance issues.
Some key points to consider when prescribing zaleplon include:
- Patients should only take zaleplon when they have at least 4 hours available for sleep
- Zaleplon should not be taken with or immediately after a high-fat meal as this can decrease its effectiveness
- Due to its potential for dependence and tolerance, zaleplon is typically prescribed for short-term use, generally not exceeding 7-10 days
- The FDA has recommended that a warning be issued regarding adverse effects associated with BzRA hypnotics, including sleepwalking, eating, driving, and sexual behavior 1
- A more recent study from 2017 found that the overall evidence for zaleplon 10 mg supports its efficacy for the treatment of sleep onset insomnia, with a reduction in sleep latency from baseline that met the criterion for clinical significance 1.
Overall, zaleplon can be an effective treatment option for insomnia, particularly for sleep initiation problems, when used at the recommended dose and with appropriate caution.
From the FDA Drug Label
The recommended dose of zaleplon capsules for most nonelderly adults is 10 mg. ... the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended
- The maximum dose of zaleplon is 20 mg 2.
- Doses above 20 mg are not recommended.
From the Research
Maximum Dose of Zaleplon
The maximum dose of zaleplon is not explicitly stated in the provided studies, but the following information can be gathered:
- Zaleplon 5 and 10 mg are the usual recommended doses, and they have been shown to significantly reduce sleep latency compared with placebo in clinical trials in nonelderly and elderly patients with insomnia 3.
- Zaleplon 20 mg has also been studied, and it has been shown to improve sleep latency and duration in nonelderly patients, but its effects on number of awakenings were inconsistent, and sleep quality generally did not improve 3.
- In one study, single daytime doses of zaleplon up to 15 mg were well-tolerated, but short-term impairment of performance occurred when zaleplon was administered during the day at doses of 20 mg or more 4.
- The recommended daily dose for most adults is 10 mg, according to one study 5.
Key Points
- Zaleplon 5 and 10 mg are the recommended doses for most adults.
- Zaleplon 20 mg has been studied, but its effects are less consistent, and it may cause short-term impairment of performance.
- Single daytime doses of zaleplon up to 15 mg are well-tolerated, but higher doses may cause impairment.
- The maximum dose of zaleplon is not explicitly stated, but doses above 20 mg have not been extensively studied.
Dosage Considerations
- The dose of zaleplon should be individualized, and the recommended daily dose for most adults is 10 mg 5.
- Zaleplon can be taken at bedtime or later in the night without residual effects the next morning 5.
- Zaleplon has a short duration of clinical effect, which may allow patients to take it later in the night without residual effects the next morning 3, 5.