What are the recommended dosages for Lunesta. How does eszopiclone affect next-day alertness. What are the potential side effects and interactions of Lunesta. Who should exercise caution when using this sleep aid.

FDA Safety Warning: Reduced Starting Dose for Lunesta

The U.S. Food and Drug Administration (FDA) has issued a significant safety announcement regarding Lunesta (eszopiclone), a widely prescribed insomnia medication. This warning stems from concerns about next-day impairment affecting driving and other activities requiring alertness.

Key points from the FDA’s safety communication include:

• The recommended starting dose of Lunesta has been decreased from 2 mg to 1 mg at bedtime.
• A study found that the previously recommended 3 mg dose can cause impairment lasting more than 11 hours after administration.
• Patients were often unaware of their impairment, raising significant safety concerns.
• The lower 1 mg starting dose aims to reduce the amount of drug remaining in the bloodstream the following day.
• Higher doses of 2 mg or 3 mg may still be prescribed if needed, but carry an increased risk of next-day impairment.

Healthcare professionals are advised to follow these new dosing recommendations when initiating Lunesta treatment. Patients currently taking Lunesta should consult their healthcare provider to determine the most appropriate dose for their individual needs.

Understanding Eszopiclone: Pharmacology and Usage

Eszopiclone, marketed under the brand name Lunesta and available as generics, belongs to a class of medications known as sedative-hypnotics. These drugs are primarily used to treat insomnia in adults.

How does eszopiclone work? Eszopiclone enhances the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that promotes sleep and relaxation in the brain. By binding to GABA receptors, eszopiclone helps initiate and maintain sleep.

In 2013, approximately 3 million prescriptions for Lunesta (eszopiclone) were dispensed in the United States, with 923,000 patients receiving the medication from outpatient retail pharmacies. This data underscores the widespread use of eszopiclone and the importance of understanding its proper dosing and potential risks.

Dosage Guidelines and Special Considerations

The FDA’s revised recommendations for Lunesta dosing are as follows:

• Starting dose: 1 mg, taken immediately before bedtime
• Maximum dose: 3 mg
• Elderly patients and those with severe liver disease: Maximum dose of 2 mg

Can the dosage be increased if needed? Yes, the 1 mg dose can be increased to 2 mg or 3 mg if necessary. However, it’s crucial to note that higher doses are associated with a greater likelihood of next-day impairment.

Healthcare providers should carefully consider each patient’s individual circumstances when prescribing Lunesta. Factors such as age, liver function, and potential drug interactions should be taken into account when determining the appropriate dosage.

Precautions for Higher Doses

Patients prescribed a 3 mg dose of Lunesta are strongly cautioned against driving or engaging in activities that require complete mental alertness the day after use. This precaution highlights the potential for significant next-day impairment even at therapeutic doses.

Next-Day Impairment: Understanding the Risks

The FDA’s warning about next-day impairment with Lunesta raises important questions about the safety of sedative-hypnotic medications. Why is next-day impairment a concern with eszopiclone?

Studies have shown that even when patients feel fully awake the morning after taking Lunesta, they may still experience decreased mental alertness. This impairment can affect various cognitive functions, including:

• Driving skills
• Memory
• Coordination
• Reaction time

Perhaps most alarmingly, patients are often unaware of their impairment, potentially leading to dangerous situations if they attempt to drive or perform other tasks requiring full alertness.

Duration of Impairment

How long can the effects of Lunesta last? Research indicates that impairment from a 3 mg dose of Lunesta can persist for more than 11 hours after taking the medication. This extended duration of action emphasizes the importance of proper dosing and patient education about the potential risks associated with eszopiclone use.

Patient Guidance and Safety Measures

For individuals prescribed Lunesta, following these guidelines can help ensure safe and effective use of the medication:

1. Take Lunesta exactly as prescribed by your healthcare provider.
2. If currently taking Lunesta, consult your doctor about the most appropriate dose given the new FDA recommendations.
3. Read the Medication Guide provided with your Lunesta prescription carefully.
4. Be aware that over-the-counter (OTC) sleep aids may not necessarily be safer than prescription medications in terms of next-morning alertness and driving ability.
5. Report any side effects experienced while taking Lunesta to your healthcare provider and the FDA MedWatch program.

It’s important to note that each patient’s situation is unique, and the appropriate dose of Lunesta should be determined through discussion with a healthcare professional.

Potential Side Effects and Adverse Reactions

While Lunesta can be an effective treatment for insomnia, it’s essential to be aware of potential side effects. Common adverse reactions associated with eszopiclone use include:

• Headache
• Dizziness
• Dry mouth
• Unpleasant taste
• Nausea
• Anxiety
• Confusion
• Depression

In rare cases, more serious side effects may occur, such as allergic reactions, abnormal thinking, or behavioral changes. Patients should seek immediate medical attention if they experience any severe or unusual symptoms while taking Lunesta.

Risk of Dependence and Withdrawal

Like other sedative-hypnotic medications, Lunesta carries a risk of physical and psychological dependence. Abrupt discontinuation of the drug may lead to withdrawal symptoms, including:

• Rebound insomnia
• Anxiety
• Tremors
• Sweating
• Gastrointestinal upset

To minimize the risk of dependence and withdrawal, healthcare providers typically recommend gradually tapering the dose when discontinuing Lunesta treatment.

Drug Interactions and Contraindications

Understanding potential drug interactions is crucial for safe use of Lunesta. Eszopiclone may interact with various medications and substances, including:

• Other central nervous system depressants (e.g., alcohol, opioids, benzodiazepines)
• Certain antifungal medications
• Some antibiotics
• HIV protease inhibitors
• Rifampin

These interactions can lead to increased sedation, impaired cognitive function, or reduced effectiveness of eszopiclone. Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking before starting Lunesta.

Contraindications

Lunesta is contraindicated in patients with known hypersensitivity to eszopiclone or any of its inactive ingredients. Additionally, caution should be exercised when prescribing Lunesta to patients with:

• Severe hepatic impairment
• History of substance abuse
• Depression or suicidal thoughts
• Respiratory disorders, such as sleep apnea

Healthcare providers should carefully evaluate the risks and benefits of Lunesta use in these patient populations.

Ongoing Evaluation and Future Research

The FDA’s safety communication regarding Lunesta highlights the need for continued evaluation of sedative-hypnotic medications. The agency has stated that it is assessing the risk of impaired mental alertness across the entire class of sleep aid drugs, including over-the-counter products.

What areas of research are being prioritized? Current and future studies are likely to focus on:

• Long-term safety and efficacy of sedative-hypnotics
• Optimizing dosing regimens to minimize next-day impairment
• Identifying patient factors that may increase susceptibility to adverse effects
• Developing alternative treatments for insomnia with improved safety profiles

As new information becomes available, the FDA has committed to updating the public and healthcare professionals. This ongoing evaluation underscores the importance of staying informed about the latest developments in sleep medicine and insomnia treatment.

Alternative Approaches to Insomnia Management

While medications like Lunesta can be effective for short-term treatment of insomnia, it’s important to consider non-pharmacological approaches as well. Cognitive Behavioral Therapy for Insomnia (CBT-I) has shown promising results in treating chronic insomnia without the risks associated with sedative-hypnotic drugs.

Other strategies that may help improve sleep quality include:

• Maintaining a consistent sleep schedule
• Creating a relaxing bedtime routine
• Optimizing the sleep environment (e.g., comfortable temperature, minimal noise and light)
• Avoiding caffeine, alcohol, and electronic devices before bedtime
• Regular exercise (but not too close to bedtime)
• Stress reduction techniques, such as meditation or deep breathing exercises

Healthcare providers should discuss these non-pharmacological options with patients, particularly those who may be at higher risk for adverse effects from sedative-hypnotic medications.

Integrating Pharmacological and Non-Pharmacological Approaches

For some patients, a combination of medication and behavioral interventions may provide the most effective treatment for insomnia. This integrated approach allows for lower doses of medications like Lunesta while addressing underlying factors contributing to sleep difficulties.

How can patients and healthcare providers determine the best treatment strategy? A thorough evaluation of the patient’s sleep patterns, medical history, and lifestyle factors is essential. This comprehensive assessment can guide the development of a personalized treatment plan that balances the benefits and risks of various interventions.

The Role of Patient Education in Safe Medication Use

Ensuring safe and effective use of Lunesta and other sleep medications relies heavily on patient education. Healthcare providers play a crucial role in:

• Explaining the proper use and potential risks of eszopiclone
• Discussing the importance of adhering to prescribed dosages
• Educating patients about the signs of next-day impairment
• Providing guidance on when to avoid driving or engaging in other potentially hazardous activities
• Encouraging open communication about any side effects or concerns

Patients should feel empowered to ask questions and seek clarification about their medication regimen. This collaborative approach between healthcare providers and patients can help minimize the risks associated with sedative-hypnotic use while maximizing the benefits for those struggling with insomnia.

The Importance of Regular Follow-Up

Regular follow-up appointments are essential for patients taking Lunesta or other sleep medications. These check-ins allow healthcare providers to:

• Assess the effectiveness of the current treatment plan
• Monitor for any adverse effects or signs of dependence
• Adjust dosages as needed
• Explore opportunities to taper or discontinue medication use when appropriate
• Reinforce key safety messages and address any new concerns

By maintaining open lines of communication and regularly evaluating treatment progress, healthcare providers can help ensure that patients receive the most appropriate and safe care for their insomnia.

Conclusion: Balancing Efficacy and Safety in Insomnia Treatment

The FDA’s safety warning regarding Lunesta (eszopiclone) underscores the complex nature of treating insomnia. While sedative-hypnotic medications can provide much-needed relief for those struggling with sleep difficulties, they also carry risks that must be carefully managed.

Key takeaways from this comprehensive review include:

• The importance of adhering to updated dosing recommendations for Lunesta
• The potential for significant next-day impairment, even at therapeutic doses
• The need for individualized treatment plans that consider patient-specific factors
• The value of integrating pharmacological and non-pharmacological approaches to insomnia management
• The critical role of patient education and regular follow-up in ensuring safe medication use

As research in sleep medicine continues to evolve, healthcare providers and patients must stay informed about the latest developments and recommendations. By working together and maintaining a balanced approach to insomnia treatment, we can strive to improve sleep quality while minimizing potential risks associated with sedative-hypnotic medications like Lunesta.

FDA Drug Safety Communication: FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose

View and print full Drug Safety Communication (PDF – 63KB)

• Safety Announcement
• Facts about eszopiclone
• Additional Information for Patients
• Additional Information for Health Care Professionals
• Data Summary
• References

Safety Announcement

[5-15-2014] The U.S. Food and Drug Administration (FDA) is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.  As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime.  Health care professionals should follow the new dosing recommendations when starting patients on Lunesta.  Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them.  

A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary).  Despite these driving and other problems, patients were often unaware they were impaired.  The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.  

Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both.  The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness.  We caution patients taking a 3 mg dose against driving or engaging in other activities that require complete mental alertness the day after use. 

We have approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations.   The drug labels for generic eszopiclone products will also be updated to include these changes.

We are continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available.  Health care professionals and patients can refer to our Sleep Disorder (Sedative-Hypnotic) Drug Information Web page to find updated information and access the latest labels for insomnia drugs.

Facts about eszopiclone 

• A sedative-hypnotic sleep medicine used to treat insomnia in adults
• Marketed under the brand name Lunesta and also as generics
• In 2013, there were approximately 3 million prescriptions dispensed and 923,000 patients who received a dispensed prescription for Lunesta (eszopiclone) from U.S. outpatient retail pharmacies.¹

Additional Information for Patients  

• Patients who take Lunesta (eszopiclone) and other medicines to help them sleep can experience decreased mental alertness the morning after use, even if they feel fully awake.
• Lunesta can cause next-day impairment of driving and other activities that require full alertness.
• The recommended starting dose of Lunesta has been lowered to 1 mg from 2 mg, to be taken once each evening immediately before bedtime.  The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to impair next-day driving and other activities that require full alertness.
• Elderly patients and patients with severe liver disease should not take doses of more than 2 mg.
• If you are currently taking Lunesta, continue taking your prescribed dose and contact your health care professional to ask about the most appropriate dose for you.  Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional.
• Patients taking a 3 mg dose of Lunesta are cautioned against driving or engaging in other activities that are hazardous or require complete mental alertness the day after use.
• Read the patient Medication Guide that comes with your Lunesta prescription.
• Take all insomnia medicines exactly as prescribed.
• Over-the-counter (OTC) insomnia medicines that are available without a prescription should not be considered safer than prescription insomnia medicines for next-morning alertness and driving.
• Talk to your health care professional if you have any questions or concerns about Lunesta or other insomnia medicines.
• Report any side effects from Lunesta or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

Additional Information for Health Care Professionals  

• Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require full alertness.
• The recommended starting dose of Lunesta has been lowered to 1 mg from 2 mg.  Dosing can be raised to 2 mg or 3 mg if clinically indicated.   The total dose of Lunesta should not exceed 3 mg, once each evening immediately before bedtime.
• Elderly patients and patients with hepatic impairment should not be prescribed doses of more than 2 mg.
• In some patients, the higher morning blood levels of Lunesta following use of the 2 mg or 3 mg doses increase the risk of next-day impairment of driving and other activities that require full alertness.
• Caution patients taking 3 mg of Lunesta against driving or engaging in activities that are hazardous or require complete mental alertness the day after use.
• Encourage patients to read the Medication Guide that comes with their Lunesta prescription.
• For all insomnia drugs, prescribe the lowest dose necessary to treat the patient’s symptoms.
• Inform patients that impairment from insomnia drugs can be present despite feeling fully awake.
• Report adverse events involving Lunesta or other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

Data Summary 

In a double-blind study of 91 healthy adults between 25 and 40 years old, the effects of Lunesta 3 mg on psychomotor function were assessed the following morning, between 7.5 and 11.5 hours after dosing.  Measures included tests of psychomotor coordination that are correlated with the ability to maintain a motor vehicle in the driving lane, tests of working memory, and subjective perception of sedation and coordination.  Compared with placebo, Lunesta 3 mg was associated with next-morning psychomotor and memory impairment that was most severe at 7.5 hours but still present and potentially clinically meaningful at 11.5 hours.  Subjective perception of sedation and coordination from Lunesta 3 mg was not consistently different from placebo, even though the subjects were objectively impaired.  Lunesta 3 mg had an impairing effect almost as large as zopiclone 7.5 mg, a similar insomnia drug.  Zopiclone, which is not approved in the United States, causes consistent psychomotor impairment such that it is often used as a positive control in driving impairment studies.

References

1. IMS, National Prescription Audit and IMS, Vector One®: Total Patient Tracker (TPT) Databases. Year 2013. Extracted April 2014.

Related Information

• Sleep Disorder (Sedative-Hypnotic) Drug Information

FDA cuts recommended Lunesta dose in half

Eszopiclone is sold by Sunovion under the brand name Lunesta.

JB Reed/Bloomberg News/GETTY IMAGES

Story highlights

FDA: The recommended starting dose for Lunesta should be 1 mg, not 2 mg

It notes studies showing “severe next-morning psychomotor and memory impairment”

Lunesta is the “No. 1 prescribed branded sleep aid,” its website says

CNN
 — 

Lunesta may help you doze off at night, but it’s the morning after that has officials concerned – which is why on Thursday they halved the recommended dosage for the well-known sleep aid.

The U.S. Food and Drug Administration cited data showing that a person may be less alert and do things such as driving less safely the day after taking Lunesta.

In particular, the federal agency pointed to one study of 91 healthy adults between the ages of 25 and 40, some of whom were given 3 mg of Lunesta, while the others got a placebo, or inactive pill.

Men and women who took the active drug had “severe next-morning psychomotor and memory impairment” some 7½ hours later, as well as “impairment to driving skills, memory and coordination as long as 11 hours after the drug is taken,” according to an FDA news release.

Sleep & Health_00005612.jpg

video

Sleep is important for health

hm sleep tips_00001123.jpg

video

Sleep tips for more zzzzzs!

As a result, the FDA decided to decrease the recommended starting dose of Eszopiclone, as sold by Sunovion under the brand name Lunesta, from 2 mg to 1 mg.

The federal agency noted that health care professionals could increase the dosage as high as 3 mg while warning of the consequences.

“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” said Dr. Ellis Unger, a drug evaluation director at the FDA.

Sunovion, the company that makes and markets Lunesta, did not immediately respond Thursday to CNN requests for comment on the recommended dosage change.

According to the product’s website, Lunesta is “the No. 1 prescribed branded sleep aid,” with more than 31 million prescriptions for the drug written. The same site states that “more than 30 studies” have shown Lunesta “to be effective in many different types of insomnia patients,” adding that “there are no restrictions on duration for taking Lunesta.”

Zolpidem

Zolpidem is a short-acting sedative-hypnotic prescribed for the treatment of insomnia, sleep disorders.

Analogues (generics, synonyms)

• Nitrest;
• Ivadal;
• Hypnogen.

Dispensed by prescription, entered in the register of strict reporting.
Active ingredient: Zolpidemum

Prescription form 148-1/u-88
Latin prescription:
Rp.: Tab. Zolpidemi
D.t.d. № 10
S. 1 tablet at night, regardless of food intake

Presentation
Coated tablets.
One tablet contains 10 mg of zolpidem hemitartrate.
In a blister pack of 15 or 30 tablets.
Packed in a cardboard box.

Mechanism of action
Specific agonist of central receptors belonging to the GABA-omega macromolecular receptor complex, which modulates the opening of the chloride ion channel.

Therapeutic indications
Insomnia when it limits the patient’s activity or exposes him to a severe stressful situation.

Directions for use
Orally, swallowed whole, with or without food, with plenty of liquid. A single dose is usually 10 mg. Elderly people suffering from liver failure. reduce dose to 5mg. The maximum daily dose is 10 mg.

Contraindications
Hypersensitivity to zolpidem, myasthenia gravis, sleep apnea syndrome, severe myocardial infarction, acute and/or severe respiratory failure.

Warnings and Precautions
Elderly, respiratory failure, especially psychotic, depression, history of alcohol or drug abuse. Risk of anterograde amnesia, psychic and paradoxical reactions (more common in the elderly), sleepwalking and decreased levels of consciousness (which can lead to falls and, therefore, serious injury). After prolonged use, there is a risk of developing tolerance, physical and mental dependence. Abrupt discontinuation causes withdrawal syndrome. Do not use for anxiety associated with depression. Regularly reassess the patient’s clinical situation. The risk of psychomotor disturbances the next day, which increases with the introduction of: doses less than 8 hours apart before performing activities that require mental activity; doses exceeding the recommended; concomitantly with another CNS depressant or other drugs that increase the plasma concentration of zolpidem, or with alcohol or drugs.

Liver failure
Contraindicated in severe liver disease as it may cause encephalopathy. Caution with intravenous infusion. use 5mg doses as they do not clear the drug as quickly as in normal people.

Renal failure
Precaution. Although dose adjustment is not required.

Interactions
Increases CNS depressant effects with: neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines,
Efficacy is reduced by: CYP3A4 inducers such as rifampicin.
Plasma concentrations are increased by: CYP3A4 inhibitors such as ketoconazole.
Sedation aggravated by: alcohol.

Pregnancy
There are insufficient data to assess their safety during pregnancy. Should be avoided during pregnancy, especially in the first trimester. If given to a woman of childbearing age, she should be advised to contact her doctor to stop treatment if she intends to become pregnant or if she suspects she is pregnant.
When administered at the last stage of pregnancy or during childbirth, effects on the newborn such as hypothermia, hypotension and mild respiratory depression can be expected due to the pharmacological action of the drug. Cases of severe respiratory depression have been reported in neonates when used with other CNS depressants in late pregnancy.
On the other hand, children born to mothers who chronically take benzodiazepines or benzodiazepine analogues late in pregnancy may develop physical dependence and there may be some risk of developing withdrawal symptoms in the postpartum period.

Breast-feeding
Since benzodiazepines and benzodiazepine-like agents are excreted in breast milk, zolpidem should not be administered to mothers during breast-feeding.

Effects on ability to drive
Zolpidem causes drowsiness. This may impair the ability to react, make it difficult to concentrate and cause amnesia, especially at the beginning of treatment or after increasing the dose. Similarly, drowsiness may persist the next morning after taking the medicine. It is not recommended to drive vehicles or mechanisms, the use of which requires special attention or concentration, until at least 8 hours have passed since taking the drug.

Adverse reactions
Daytime sleepiness, affective dullness, decreased alertness, confusion, fatigue, headache, dizziness, worsening insomnia, amnesia, hallucinations, agitation, nightmares, ataxia, dizziness, diplopia, depression, back pain, muscle weakness, diarrhea, nausea, vomiting, abdominal pain, upper and lower respiratory tract infection, skin reactions.

Overdose
Flumazenil antidote.

8 (499) 398 – 20 – 68 8 (925) 822 – 88 – 61

Request a call back

safe use of zolpidem

Home >
News >
Recommendations for the safe use of the drug zolpidem