Is Lunesta (Eszopiclone) safe?

From the Guidelines

Lunesta (eszopiclone) is generally considered safe when used as prescribed for short-term treatment of insomnia, typically at doses of 1-3 mg taken right before bedtime. However, like all sleep medications, it carries risks including side effects such as unpleasant taste, headache, dizziness, and morning drowsiness. More serious concerns include complex sleep behaviors (like sleep-walking or sleep-driving), allergic reactions, and the potential for dependence or addiction with prolonged use. Lunesta should be used for the shortest duration necessary, usually no more than 7-10 days continuously. It may interact with other medications, particularly those that depress the central nervous system like alcohol, opioids, or certain antidepressants. Lunesta works by enhancing the effect of GABA, a neurotransmitter that inhibits brain activity, helping to induce sleep. Patients should discuss their complete medical history and medication list with their doctor before starting Lunesta, as it may not be appropriate for everyone, especially those with liver disease, respiratory conditions, or a history of substance abuse.

Key Considerations

• The most recent and highest quality study, published in 2020 1, suggests that nonbenzodiazepine BZRAs, such as eszopiclone, improve sleep efficiency and other sleep outcomes compared to placebo.
• However, the study also notes that these agents carry risks, including complex sleep behaviors and allergic reactions, and should be used at the lowest effective dose and for the shortest possible duration.
• The American College of Physicians recommends that clinicians use a shared decision-making approach when considering pharmacological therapy for insomnia, including a discussion of the benefits, harms, and costs of treatment 1.
• Patients should be counseled on the potential risks of Lunesta, including the risk of serious injuries caused by sleep behaviors, and should be monitored closely for signs of dependence or addiction.

Important Safety Information

• Lunesta may cause complex sleep behaviors, such as sleep-walking or sleep-driving, and patients should be warned about the risk of these behaviors 1.
• The medication may also cause allergic reactions, and patients should be monitored for signs of an allergic reaction, such as hives or difficulty breathing.
• Lunesta may interact with other medications, particularly those that depress the central nervous system, and patients should be advised to avoid using these medications concurrently.

From the FDA Drug Label

Eszopiclone tablets may cause serious side effects that you may not know are happening to you These side effects include: sleepiness during the day, not thinking clearly, act strangely, confused, or upset, “sleep-walking” or doing other activities when you are asleep like: eating, talking, having sex, driving a car The morning after you take eszopiclone tablets your ability to drive safely and think clearly may be decreased. Possible serious side effects of eszopiclone tablets include: getting out of bed while not being fully awake and do an activity that you do not know you are doing, abnormal thoughts and behavior, memory loss, anxiety, severe allergic reactions.

Safety of Lunesta (Eszopiclone): Lunesta is not completely safe, as it can cause serious side effects such as sleepiness during the day, confusion, and abnormal thoughts and behavior. It can also impair your ability to drive safely and think clearly the morning after taking it. Additionally, it can cause severe allergic reactions, memory loss, and anxiety.

• Key Safety Concerns:
  • Serious side effects
  • Impaired driving ability
  • Abnormal thoughts and behavior
  • Severe allergic reactions
  • Memory loss
  • Anxiety 2, 2, 2

From the Research

Safety of Lunesta

• Lunesta, also known as eszopiclone, is a hypnotic drug used to treat insomnia 3, 4, 5.
• Studies have shown that eszopiclone is effective for the treatment of insomnia with no evidence of tolerance, dependence, or abuse 3.
• However, eszopiclone has been associated with some adverse effects, including unpleasant taste, dry mouth, somnolence, and dizziness 4.
• The risk of adverse events is higher in elderly individuals with cognitive and motor impairments and individuals who are at increased risk of using eszopiclone in a non-recommended way 4.

Comparison with Other Hypnotics

• Eszopiclone has been compared to other hypnotics, such as zolpidem, and has been shown to have a lower incidence of residual daytime sleepiness and risk of falls 6.
• However, zolpidem has been associated with a wide variety of adverse effects, including an increased risk of falls, hip fractures, and complex behaviors such as sleepwalking and hallucinations 6.

Efficacy and Safety Profile

• Meta-analytic integrations of participant-reported data on sleep efficacy outcomes have demonstrated better results for eszopiclone compared to placebo, including a decrease in sleep onset latency and wake time after sleep onset, and an increase in total sleep time 4.
• The evidence for the efficacy and safety of eszopiclone has been rated as moderate quality, with low quality evidence for rebound effects and next-day functioning 4.
• Eszopiclone appears to be an efficient drug with moderate effects on sleep onset and maintenance, and there is no or little evidence of harm if taken as recommended 4.