What to monitor in elderly patients using Ambien (zolpidem)?

From the Guidelines

When monitoring elderly patients taking Ambien (zolpidem), healthcare providers should closely watch for signs of excessive sedation, confusion, memory problems, and increased fall risk, as these patients are at higher risk of adverse outcomes due to altered drug metabolism and increased sensitivity to sedative effects 1.

Key Monitoring Parameters

• Excessive sedation
• Confusion
• Memory problems
• Increased fall risk
• Morning drowsiness
• Dizziness
• Cognitive impairment
• Behavioral changes such as sleep-walking, sleep-eating, or other complex sleep behaviors

Special Considerations

• Start with the lowest effective dose (typically 5 mg for immediate-release in elderly) and regularly assess for adverse effects
• Pay special attention to respiratory function, especially in those with pre-existing conditions like sleep apnea or COPD
• Regular medication reviews are essential as elderly patients often take multiple medications that might interact with Ambien
• Watch for signs of dependence or tolerance developing over time
• Blood pressure and heart rate should be checked periodically, and kidney and liver function tests may be necessary as these organs process the medication differently in older adults

Rationale

The use of Ambien in elderly patients requires careful monitoring due to the increased risk of adverse outcomes, including falls, cognitive decline, and respiratory depression 1. The American College of Physicians recommends starting with the lowest effective dose and regularly assessing for adverse effects 1. Additionally, the FDA has released a safety announcement on the risk of serious injuries caused by sleep behaviors associated with nonbenzodiazepine BZRAs, such as zolpidem 1. Therefore, it is essential to closely monitor elderly patients taking Ambien and adjust the treatment plan as needed to minimize the risk of adverse outcomes.

From the FDA Drug Label

A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U. S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg. The dose of zolpidem tartrate in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see WARNINGS AND PRECAUTIONS (5.2)]. Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of zolpidem tartrate in these patients is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.2), USE IN SPECIFIC POPULATIONS (8. 5)].

During use of Ambien in elderly people, it is recommended to monitor for:

• Falls: as the risk of falls is increased, especially in patients ≥70 years of age and those receiving doses >10 mg.
• Confusion: as the risk of confusion is increased, especially in patients ≥70 years of age and those receiving doses >10 mg.
• Impaired motor and/or cognitive performance: as elderly patients may be especially sensitive to the effects of zolpidem tartrate. It is also recommended to use the lowest effective dose, which is 5 mg once daily immediately before bedtime, to minimize adverse effects 2, 2.

From the Research

Monitoring During Use of Ambien in Elderly People

When using Ambien (zolpidem) in elderly people, several factors should be monitored due to the potential risks associated with its use.

• Adverse symptoms such as impaired balance and/or falls, and morning drowsiness, as reported in a study 3
• Cognitive function, as some studies suggest that long-term use of zolpidem may be associated with cognitive impairment, although the evidence is not conclusive 4, 5
• Risk of falls, fractures, dementia, cancer, and stroke, as suggested by some retrospective studies 6
• Dosage and treatment duration, as zolpidem appears to be effective at lower doses and for short-term treatment among the elderly 6
• Potential interactions with other medications, as well as the patient's medical history and current health status

Safety Precautions

To minimize the risks associated with zolpidem use in elderly people, the following safety precautions should be taken:

• Prescribe the lowest effective dose for the shortest duration necessary 6
• Monitor patients closely for adverse symptoms and cognitive changes 3, 4
• Consider alternative treatments, such as non-pharmacological approaches or other medications, if necessary 7
• Educate patients and their caregivers about the potential risks and benefits of zolpidem use, as well as the importance of following the prescribed treatment plan 3, 6

Alternative Treatments

For elderly people with insomnia, alternative treatments may be considered, such as:

• Non-pharmacological approaches, such as sleep restriction-sleep compression therapy and cognitive behavioral therapy for anxiety or insomnia 7
• Other medications, such as eszopiclone, zopiclone, or zaleplon, although the evidence for their safety and efficacy in elderly people is limited 4, 5