What is the dosage for Zolpidem?

Zolpidem Dosage

The FDA-recommended starting dose of zolpidem is 5 mg for all adults (both men and women) taken immediately before bedtime with at least 7-8 hours remaining before planned awakening, though men may alternatively start at 10 mg if the 5 mg dose proves ineffective. 1

Standard Dosing for Adults

• Initial dose: 5 mg for women, 5-10 mg for men taken once nightly immediately before bedtime 1
• The 5 mg starting dose for women is mandatory due to 45% higher drug exposure (Cmax and AUC) compared to men at equivalent doses, resulting from slower clearance rates 1
• If 5 mg is ineffective, the dose may be increased to 10 mg, but this higher dose increases risk of next-day impairment of driving and activities requiring full alertness 1
• Maximum dose: 10 mg once daily—never exceed this dose or readminister during the same night 1

Special Population Dosing

Elderly or Debilitated Patients

• Recommended dose: 5 mg once daily regardless of gender 1
• Elderly patients show particular sensitivity to zolpidem effects and have similar clearance between men and women 1
• Higher doses (>10 mg) in patients ≥70 years were associated with 82% of fall reports and 78% of confusion cases in clinical trials 1

Hepatic Impairment

• Mild to moderate impairment: 5 mg once daily 1
• Severe impairment: Avoid zolpidem entirely as it may contribute to encephalopathy 1

Renal Impairment

• Dosage reduction is prudent, though specific FDA recommendations are not provided 2

Extended-Release Formulation

• Starting dose: 6.25 mg for women, 6.25-12.5 mg for men 3, 4
• The FDA reduced recommended starting doses from the original 12.5 mg to 6.25 mg due to next-day impairment concerns 3
• Extended-release may be more effective for sleep maintenance, reducing wake time after sleep onset by 25 minutes 4

Administration Guidelines

• Take on an empty stomach immediately before bedtime—food delays and reduces effectiveness 1
• Do not take with or immediately after meals 1
• Ensure 7-8 hours available for sleep before planned awakening 1
• Avoid combining with alcohol or other CNS depressants; dosage adjustment necessary when combined with CNS depressants 1

Clinical Efficacy

• Zolpidem 10 mg reduces sleep onset latency by approximately 10-15 minutes compared to placebo 3, 4
• Total sleep time increases by 23-29 minutes with standard formulation 3, 4
• Sleep quality shows moderate to large improvement based on standardized mean difference 3
• Effects are evident from the first night of treatment 3, 5

Critical Safety Warnings

• Complex sleep behaviors: FDA warnings include sleepwalking, sleep-driving, sleep-eating, and other activities while not fully awake 4
• Next-day impairment: Women and patients taking 10 mg doses show elevated morning blood levels increasing accident risk 1
• Falls and fractures: Relative risk for hip fractures is 1.92 (95% CI 1.65-2.24) in zolpidem users 6
• Increased suicidality: Odds ratio of 2.08 (95% CI 1.83-2.63) for suicide attempts regardless of psychiatric comorbidity 6
• Pregnancy category C: Associated with increased low birth weight (OR 1.39), preterm delivery (OR 1.49), and cesarean deliveries (OR 1.74), though not congenital abnormalities 6

Withdrawal and Discontinuation

• Rebound insomnia may occur on the first night after discontinuation, with sleep onset latency increased by 13 minutes (95% CI 4.3-21.7) 6
• Withdrawal seizures reported with chronic high-dose use (450-600 mg/day, some as low as 160 mg/day) 6
• For breastfeeding mothers, consider interrupting nursing and pumping/discarding milk for 23 hours (5 elimination half-lives) after administration 1

Common Pitfalls to Avoid

• Do not use 10 mg as universal starting dose—the FDA explicitly lowered recommendations from historical 10 mg starting doses due to safety concerns 3
• Do not prescribe same dose for men and women—pharmacokinetic differences mandate lower dosing in women 1
• Do not ignore food interactions—taking with meals significantly impairs absorption and delays onset 1
• Do not continue beyond short-term use without reassessment—indicated for ≤4 weeks of treatment 5