What is the standard dose of zaleplon (sedative-hypnotic medication) for insomnia?

Standard Dose of Zaleplon for Insomnia

The standard dose of zaleplon is 10 mg for non-elderly adults and 5 mg for elderly patients (≥65 years), taken immediately before bedtime. 1, 2

Dosing by Patient Population

Non-Elderly Adults

• 10 mg is the recommended dose for adults with insomnia, taken immediately before bedtime 1, 2
• The 10 mg dose consistently demonstrates clinically significant reduction in sleep latency compared to placebo, with moderate to high strength of evidence 2
• The 5 mg dose is less consistently effective than the 10 mg dose for sleep onset insomnia 1

Elderly Patients (≥65 years)

• 5 mg is the recommended starting dose due to increased sensitivity to hypnotics 1, 2
• Elderly patients should not routinely receive the 10 mg dose initially, though it may be considered if 5 mg is inadequate 1
• Pharmacokinetic studies show no significant differences in zaleplon metabolism between elderly and younger adults, but the lower dose recommendation is based on increased sensitivity to hypnotic effects 3

Special Populations Requiring Dose Adjustment

• Hepatic impairment: Dose should be reduced to 5 mg in patients with mild to moderate hepatic impairment due to 70-87% reduction in oral clearance 3
• Zaleplon is not recommended for patients with severe hepatic impairment 3
• Renal impairment: No dose adjustment necessary, as renal excretion accounts for <1% of elimination 3

Clinical Efficacy Profile

What Zaleplon Does Well

• Zaleplon is specifically indicated for sleep onset insomnia, not sleep maintenance problems 1, 2
• The 10 mg dose reduces sleep latency by approximately 10-20 minutes (15-30% improvement) compared to placebo 3, 4
• Effects are evident from the first night of treatment 4

What Zaleplon Does NOT Do Well

• Minimal effects on sleep maintenance parameters such as wake after sleep onset (WASO) or number of awakenings 1, 2
• Total sleep time improvements are modest (approximately 21.5 minutes) and not consistently significant compared to placebo 1
• Sleep quality improvements generally fail to meet criteria for clinical significance 5

Administration Guidelines

Timing and Food Interactions

• Take immediately before bedtime on an empty stomach 3
• High-fat/heavy meals delay absorption by approximately 2 hours and reduce peak concentration by 35% 3
• Do not take with or immediately after a meal, as this may delay onset of effect 3

Unique Middle-of-Night Dosing Option

• Due to its ultra-short half-life (approximately 1 hour), zaleplon can be taken later in the night if patients have difficulty sleeping 4, 6
• Can be taken ≤2 hours before awakening without "hangover" effects 7
• This flexibility distinguishes zaleplon from other hypnotics 6

Safety and Tolerability

Adverse Events

• Treatment-emergent adverse events show no significant difference from placebo at recommended doses (5 mg and 10 mg) 1, 2
• Most common adverse event is headache (15-18%), but incidence is similar to placebo 2, 7
• No significant withdrawal symptoms or rebound insomnia observed following discontinuation at recommended doses 2, 8

Residual Effects

• No next-day psychomotor or cognitive impairment with 5 mg or 10 mg doses 4, 6
• The 10 mg dose produces minimal or no impairment even when administered as little as 1 hour before waking 6
• No impairment of actual driving when administered 4 hours before waking 6

Important Clinical Caveats

When NOT to Use Higher Doses

• The 20 mg dose (above standard dosing) impairs psychomotor function and memory immediately after administration, though next-day effects are not observed 4
• The 20 mg dose is not routinely recommended despite showing greater efficacy, due to safety concerns 3

Duration of Efficacy

• Tolerance to hypnotic effects generally does not occur during 5 weeks of treatment 4
• Long-term studies (6-12 months) show sustained efficacy without tolerance development 4
• The 10 mg dose maintained superiority over placebo through 35 nights of treatment 3

Comparison to Other Hypnotics

• Zaleplon has a better psychomotor profile than comparator agents (zolpidem, zopiclone, triazolam, flurazepam) 4, 6
• Unlike zolpidem 5 mg, zaleplon shows no clinically significant rebound insomnia after discontinuation 8
• The ultra-short half-life (1 hour) distinguishes zaleplon from all other commonly used hypnotics 6