What is the maximum recommended dose of Ambien (zolpidem)?

Maximum Recommended Dose of Ambien (Zolpidem)

The maximum recommended dose of zolpidem is 10 mg for adult men and 5 mg for adult women when using immediate-release formulations, and 12.5 mg for men and 6.25 mg for women when using extended-release formulations. 1, 2, 3

Standard Dosing by Population

Adult Women

• 5 mg immediate-release or 6.25 mg extended-release is the maximum recommended dose 1, 2, 3
• Women clear zolpidem approximately 45% slower than men, resulting in higher plasma concentrations at equivalent doses 3
• The FDA specifically mandated lower doses for women in 2013 due to next-morning impairment risk 4, 1

Adult Men

• 10 mg immediate-release or 12.5 mg extended-release is the maximum recommended dose 1, 2, 3
• The FDA explicitly warns against exceeding these maximum amounts 2

Elderly Patients (≥65 years)

• 5 mg immediate-release or 6.25 mg extended-release regardless of sex 1, 2, 3
• Elderly patients showed increased adverse events including dizziness (23.5% vs 1.5% placebo), confusion (particularly in those ≥70 years), and falls (93% of fall cases occurred in patients ≥70 years) 3
• The 5 mg dose minimizes adverse effects related to impaired motor and cognitive performance in this population 3

Hepatic Impairment

• 5 mg once daily for mild to moderate hepatic impairment 3
• Avoid completely in severe hepatic impairment as it may contribute to encephalopathy 3

Critical Administration Requirements

• Take immediately before bedtime on an empty stomach 1
• Do not take with or immediately after meals, as food delays drug effect 1
• Avoid combining with alcohol or other CNS depressants 1
• Ensure at least 7-8 hours available for sleep to minimize next-day impairment 1

Important Safety Warnings

Complex Sleep Behaviors

• The FDA has issued warnings about sleep-related behaviors including sleepwalking, sleep-eating, and sleep-driving that can occur at therapeutic doses 1
• These behaviors are not dose-dependent and have been reported even in patients without prior history of sleepwalking 5

Risk of Falls and Fractures

• Zolpidem increases fall risk with an odds ratio of 4.28 (P <0.001) in hospitalized patients 5
• Hip fracture risk is elevated with a relative risk of 1.92 (95% CI 1.65-2.24) 5
• CNS-related adverse events (confusion, dizziness, daytime sleepiness) occurred in 80.8% of inpatients aged ≥50 years 5

Withdrawal Considerations

• Gradual dose reduction is required after prolonged use to minimize withdrawal symptoms 2
• Seizures have been reported following abrupt withdrawal, particularly in patients taking high doses (450-600 mg/day), though cases have occurred at doses as low as 160 mg/day 5
• Rebound insomnia can occur, with sleep onset latency significantly increased by 13.0 minutes on the first night after stopping (95% CI 4.3-21.7; P<0.01) 5

Pregnancy and Lactation

• FDA pregnancy category C—avoid use during pregnancy 1, 5
• Increased risk of low birth weight (OR 1.39), preterm delivery (OR 1.49), and small for gestational age babies (OR 1.34) 5
• Breastfeeding mothers should monitor infants for excess sedation, hypotonia, and respiratory depression, or consider interrupting breastfeeding for 23 hours after administration 3

Common Pitfall to Avoid

Never exceed the sex-specific maximum doses. The most common prescribing error is using 10 mg in women or elderly patients, which significantly increases the risk of next-day impairment, falls, and complex sleep behaviors 1, 2, 3. The FDA dose reduction in 2013 was specifically implemented because of documented harm from higher doses in these populations 4, 1.