Lunesta dosages: Lunesta (eszopiclone) dosing, indications, interactions, adverse effects, and more
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.
The total dose of Lunesta should not exceed 3 mg, once each evening immediately before bedtime.
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
- 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.
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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.
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safe use of zolpidem
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Recommendations for the safe use of the drug zolpidem
Modern life in a metropolis is associated with chronic persistent stress, unfavorable ecology, impaired diet, sleep and rest. These unfavorable factors are the cause of the development of many pathological conditions. Often their first and only manifestations are symptoms of a sleep disorder. The most common complaints that occur in various sleep disorders:
When many patients visit doctors of various specialties, complaints of sleep disturbance are quite common, although they are not a reason to visit a doctor. The indication for pharmacotherapy of sleep disorders is the persistence and duration of these disorders, which significantly impair the quality of life. Drug therapy is carried out with the ineffectiveness of recommendations for compliance with the regimen, general hygiene measures. Recently, Zolpidem is often prescribed to patients with sleep disorders by doctors of various specialties. However, not always, as practice shows, this takes into account the data relating to its safety. The main problem of the drug treatment of insomnia with Zolpidem at present is not so much its lack of effectiveness, but the lack of safety of treatment with this drug if it is used in violation of the instructions. Compliance with the requirements for the prescription and use of Zolpidem should not only reduce the risk associated with the drug, but also prevent its discrediting. FC MBLS considered it appropriate to inform the medical community, as well as consumers, about measures to prevent possible negative consequences associated with the use of this drug, which are presented below as recommendations. Zolpidem is registered in Russia under the trade names Gipnogen, Zolpidem tartrate, Zonadin, Nitrest, Sanval, Snovitel, Ivadal, Zolsana. Prescribers of Zolpidem and patients should review these guidelines before using Zolpidem. This information is not intended to replace the patient’s medical advice regarding treatment with this drug. Contents of recommendations I. What is Zolpidem? II. What is important to know before you start using Zolpidem? III. Who should not take Zolpidem and when? IV. How should I take Zolpidem? V. What adverse side effects can occur with Zolpidem? VI. Minimizing the risks associated with taking Zolpidem VII. How to store Zolpidem. VIII. Composition of Zolpidem. I. What is Zolpidem? Zolpidem is a sleep aid with a short duration of action. II. What is important to know before you start using Zolpidem? When taking Zolpidem, symptoms of somnambulism may appear – the patient may get out of bed in a sleepy state and perform various activities that he does not remember in the morning. The combined use of Zolpidem with hypnotics, drugs that depress the function of the central nervous system, as well as in doses exceeding the maximum recommended, the risk of sleepwalking increases. Activities that the patient can perform while drowsy: driving (sleep driving), preparing and eating food, talking on the phone, having sex, walking, etc. hazardous activities that require increased concentration of attention and speed of psychomotor reactions, as well as when drinking alcohol. When prescribing the drug to patients with concomitant depressive conditions, it is necessary to take into account the possibility of increasing suicidal tendencies. Zolpidem is not intended for use in children under 18 years of age. Exceeding the dosage of the drug is contraindicated, because this may be associated with the risk of developing serious negative consequences. Long-term use of zolpidem is addictive. Particular attention should be paid when prescribing Zolpidem to elderly patients, since the occurrence of adverse reactions in them is observed more often than in patients of other age groups. Do not take Zolpidem for more than 4 weeks. If symptoms of sleep disturbance persist, the patient should consult a doctor, as these may be symptoms of various diseases. III. Who should not take Zolpidem and when?
The attending physician must be informed about all medicines, vitamins and herbal preparations that the patient consumes, as they can interact with each other, leading to undesirable consequences. Do not take Zolpidem with the following medicines:
Use Zolpidem with caution with the following medicines:
IV. How do I take Zolpidem?
The patient should see a doctor if:
Zolpidem is not recommended for use without a doctor’s prescription. It is not recommended to pass Zolpidem to others, even if they have similar symptoms of sleep disturbance. This can harm their health. V. What adverse reactions (AEs) can occur with Zolpidem? No. 1 provides a list of possible ADRs for the drug Zolpidem. Tab. #1 Possible ADRs that occur while taking Zolpidem.
VI. Minimizing the risks associated with taking Zolpidem Before prescribing Zolpidem, the doctor should:
VII. How to store Zolpidem?
VIII. What is in Zolpidem? Active ingredient : Zolpidem Excipients : Hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium glycolate, titanium dioxide, dye – red steel, polysorbate 8 0 Sources:
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Much less frequently, complaints of sleep disturbance come to the fore. Many doctors in their practice, without establishing the true cause of sleep disturbance, easily prescribe sleeping pills. However, it is known that sleep disturbance can be one of the manifestations of various diseases, physiological and pathological conditions, as well as a consequence of drug exposure. This must be taken into account when choosing a method of corrective therapy. This should also take into account the high frequency of self-medication and over-the-counter dispensing of some sleeping pills, which not only can aggravate the clinical situation, but also contribute to the risk of developing serious adverse reactions.
Improves the ability to fall asleep, increases the duration and improves the quality of sleep. It has a sedative, slightly pronounced anxiolytic, central muscle relaxant and anticonvulsant action.
regmed.ru/ in the Pharmacovigilance section).