From the Guidelines
Eszopiclone is not recommended as a long-term medication for treating insomnia due to the risks of tolerance, dependence, and rebound insomnia, as well as the potential for serious adverse effects. The FDA has approved eszopiclone for short-term use, typically for 7-10 days and rarely beyond 2-4 weeks 1. According to the American College of Physicians, evidence is insufficient to evaluate the balance of benefits and harms of long-term use of pharmacologic treatments, including eszopiclone, for adults with chronic insomnia disorder 1.
Some key points to consider when prescribing eszopiclone include:
- The medication should be used at the lowest effective dose and for the shortest duration necessary to treat the insomnia 1
- Patients should be closely monitored for signs of tolerance, dependence, and rebound insomnia
- Alternative treatments, such as cognitive behavioral therapy for insomnia (CBT-I), should be considered for patients with chronic insomnia, as they provide sustainable benefits without the risks associated with long-term medication use
- The FDA suggests dosages lower than those used in many studies, especially for older adults, due to the increased risk of adverse effects 1
Overall, while eszopiclone may be effective in the short-term treatment of insomnia, its use as a long-term medication is not recommended due to the potential risks and lack of evidence supporting its long-term safety and efficacy.
From the FDA Drug Label
The long-term 6-month study in adult insomnia patients, 7.2% of 195 patients who received placebo and 12. 8% of 593 patients who received 3 mg eszopiclone discontinued due to an adverse reaction.
The FDA drug label does provide some information about the long-term use of eszopiclone.
- Long-term use: Eszopiclone was studied in a 6-month trial in adult insomnia patients, which suggests that it can be used for an extended period.
- Key findings: In this long-term study, 12.8% of patients who received 3 mg eszopiclone discontinued treatment due to an adverse reaction, compared to 7.2% of patients who received placebo 2. However, the label does not explicitly state that eszopiclone is approved for long-term use, and the decision to use it for an extended period should be made on a case-by-case basis, considering the potential benefits and risks.
From the Research
Eazopiclone as a Long-Term Medication
- Eazopiclone, also known as eszopiclone, is a nonbenzodiazepine hypnotic agent used for the treatment of insomnia 3, 4, 5.
- Studies have shown that eszopiclone is effective and safe for long-term use in the treatment of chronic primary insomnia in non-elderly and elderly subjects 3, 5.
- A 12-month study found that eszopiclone was associated with a sustained beneficial effect on sleep induction and maintenance, with no occurrence of tolerance 3.
- Another study found that eszopiclone did not produce rebound insomnia or serious withdrawal effects after discontinuation 5.
- A systematic review of 14 randomized controlled trials found that eszopiclone was effective in improving sleep onset and maintenance, with moderate quality evidence 6.
- The FDA label for eszopiclone does not specify a limited duration of use, and a panel of sleep experts agreed that eszopiclone can be used for long-term treatment of chronic insomnia in the appropriate clinical setting 7.
Key Findings
- Eszopiclone is effective and safe for long-term use in the treatment of chronic primary insomnia 3, 5.
- Eszopiclone does not produce rebound insomnia or serious withdrawal effects after discontinuation 5.
- Eszopiclone is associated with a sustained beneficial effect on sleep induction and maintenance, with no occurrence of tolerance 3.
- The FDA label for eszopiclone does not specify a limited duration of use 7.