What is the recommended dosing for Lunesta (eszopiclone) in the treatment of insomnia?

Lunesta (Eszopiclone) Dosing

Start with 1 mg immediately before bedtime for most adults, with the option to increase to 2 mg or 3 mg based on clinical response, but never exceed 3 mg nightly. 1

Standard Adult Dosing (Ages 18-64)

• Initial dose: 1 mg at bedtime is the FDA-recommended starting point to minimize next-day impairment risk 1
• Titration: Increase to 2 mg or 3 mg if the 1 mg dose proves insufficient for sleep onset or maintenance 1
• Maximum dose: 3 mg once daily immediately before bedtime—exceeding this dose is contraindicated 1
• The 2 mg and 3 mg doses carry higher risk of next-morning driving impairment and reduced alertness compared to 1 mg 1

Elderly or Debilitated Patients (≥65 Years)

• Maximum dose: 2 mg at bedtime—do not exceed this in geriatric populations 1
• For sleep onset complaints specifically: 1 mg is the appropriate dose in elderly patients whose primary issue is difficulty falling asleep 2
• The 2 mg dose effectively induces and maintains sleep in elderly patients while minimizing fall risk and cognitive impairment 3

Special Populations Requiring Dose Reduction

• Severe hepatic impairment: Maximum 2 mg due to reduced drug clearance 1
• Concurrent potent CYP3A4 inhibitors: Maximum 2 mg (examples include ketoconazole, clarithromycin, ritonavir) 1
• No renal dose adjustment required for any degree of kidney dysfunction 4

Critical Administration Guidelines

• Take immediately before bedtime with at least 7-8 hours available for sleep to avoid next-day impairment 1
• Avoid high-fat meals: Taking eszopiclone with or immediately after heavy, high-fat food slows absorption and reduces effectiveness for sleep onset 1
• CNS depressant co-administration: Reduce eszopiclone dose when combining with other sedatives, opioids, or alcohol due to additive effects 1

Duration of Therapy

• Unlike older hypnotics, eszopiclone is approved for long-term use without time restrictions 5, 3
• Clinical trials demonstrate sustained efficacy up to 12 months without tolerance development 6
• No rebound insomnia occurs with 3 mg doses upon discontinuation, though 2 mg may cause mild rebound in non-elderly patients 6

Common Pitfalls to Avoid

• Do not start at 3 mg: The FDA explicitly requires starting at 1 mg to assess tolerance and minimize adverse effects 1
• Do not combine with other sedatives without dose reduction: This substantially increases fall risk, respiratory depression, and complex sleep behaviors 1
• Do not use in patients unable to dedicate 7-8 hours to sleep: This creates dangerous next-day impairment 1

Efficacy by Dose

• 2 mg dose: Reduces sleep latency by 10-14 minutes and wake after sleep onset by similar amounts compared to placebo 7
• 3 mg dose: Improves sleep efficiency by 5.61% and total sleep time by 28-57 minutes versus placebo 7, 8
• Both doses significantly improve subjective sleep quality and next-day functioning 5, 3

Most Common Adverse Effects

• Unpleasant/metallic taste: 17-26% of patients (versus 0.5-5.6% placebo)—most frequent side effect 7
• Somnolence: 8.8-9.1% (versus 2.6-3.2% placebo) 7
• Dry mouth: 6.6% (versus 1.5% placebo) 7
• Dizziness: 9.8% (versus 3.1% placebo) 7
• Headache shows no difference from placebo across all doses 7