What is the recommended treatment approach for patients with insomnia using Lunesta (eszopiclone)?

From the Guidelines

The recommended treatment approach for patients with insomnia using Lunesta (eszopiclone) involves starting with the lowest effective dose of 1 mg immediately before bedtime, with the option to increase to 2-3 mg if needed, as suggested by the American Academy of Sleep Medicine clinical practice guideline 1.

Key Considerations

• For elderly patients, the initial dose should be 1 mg with a maximum of 2 mg to reduce side effect risks.
• Treatment should be short-term (7-10 days) when possible, though some patients may require longer therapy.
• Patients should take Lunesta only when they have at least 8 hours available for sleep to avoid next-day impairment.
• Common side effects include unpleasant taste, headache, dizziness, and morning drowsiness.
• Patients should be warned against combining Lunesta with alcohol or other CNS depressants, which can increase respiratory depression risks.

Mechanism of Action and Alternative Approaches

• Lunesta works by enhancing the effect of GABA, an inhibitory neurotransmitter that promotes sleep.
• Cognitive behavioral therapy for insomnia (CBT-I) should be considered as a complementary or alternative approach for long-term insomnia management, as recommended by the American College of Physicians guideline 1.

Important Warnings and Precautions

• Regular reassessment is important to evaluate ongoing need, effectiveness, and potential development of tolerance or dependence.
• The FDA has approved pharmacologic therapy for short-term use (4 to 5 weeks), and patients should not continue using the drugs for extended periods without further evaluation, as noted in the guideline 1.

From the FDA Drug Label

Eszopiclone tablets are indicated for the treatment of insomnia. The clinical trials performed in support of efficacy were up to 6 months in duration. The effect of eszopiclone on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18 to 86) with chronic and transient insomnia in six placebo-controlled trials of up to 6 months’ duration.

The recommended treatment approach for patients with insomnia using Lunesta (eszopiclone) is to take the medication exactly as prescribed, right before bedtime, and to get a full night's sleep of 7-8 hours before being active again.

• Dosage: The recommended adult dose is 2 to 3 mg, and the elderly dose is 1 to 2 mg.
• Administration: Take eszopiclone tablets right before you get into bed, and do not take with or right after a meal.
• Duration: The clinical trials were up to 6 months in duration, and the medication can be taken for an extended period, but patients should be monitored for signs of tolerance or dependence.
• Side effects: Patients should be aware of the possible side effects, including sleepiness during the day, not thinking clearly, acting strangely, and memory loss, and should report any concerns to their doctor 2, 2, 2.

From the Research

Treatment Approach for Insomnia using Lunesta (Eszopiclone)

The recommended treatment approach for patients with insomnia using Lunesta (eszopiclone) involves the use of eszopiclone as a nonbenzodiazepine hypnotic agent, which is approved in the US as an oral, once-nightly therapy for insomnia in adults 3, 4.

Efficacy of Eszopiclone

• Eszopiclone significantly improves both sleep onset and sleep maintenance compared with placebo in adult and elderly patients with primary insomnia 3, 4.
• Eszopiclone also improves sleep parameters in patients with insomnia coexisting with other conditions that disturb sleep (co-morbid insomnia) 3, 4.
• Short-term eszopiclone produces improvements in daytime functioning in patients with co-morbid insomnia, and six months' therapy in adults with primary insomnia improves daytime functioning and health-related quality of life 3, 4.

Safety and Tolerability

• Eszopiclone is generally well tolerated, with no evidence of tolerance during 12 months of treatment and no rebound insomnia or serious withdrawal effects on discontinuation 3, 4.
• Adverse events during treatment that are documented more frequently under eszopiclone compared to placebo include unpleasant taste, dry mouth, somnolence, and dizziness 5.

Cost-Effectiveness

• A cost-utility analysis suggested that eszopiclone is cost-effective for the treatment of primary insomnia in the US 3, 6.
• Eszopiclone is more expensive than some other nonbenzodiazepine hypnotics and benzodiazepine hypnotics, but less expensive than controlled-release zolpidem 6.

Alternative Treatment Options

• Cognitive-behavioral therapy for insomnia (CBT-i) is a highly effective treatment for insomnia, with results equivalent to sleep medication and no side effects 7.
• CBT-i is underutilized due to a shortage of trained practitioners and lack of patient awareness, highlighting the need for physicians and healthcare providers to educate patients about this treatment option 7.