What is Lunesta?
Lunesta (eszopiclone) is a non-benzodiazepine, oral, sedative drug (“sleeping pill”) used to treat insomnia. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening in the morning not feeling refreshed. Lunesta was formerly known as Estorra.
Lunesta is a controlled substance. Patients taking Lunesta or any other sedative drug may become dependent on the drug for sleep and experience withdrawal symptoms when Lunesta is discontinued.
Drug interactions of Lunesta include alcohol (which causes sedation) and drugs that have sedating effects because their sedating effects, when added to those of Lunesta, may cause excessive sedation. Drugs that reduce the action of liver enzymes that break down Lunesta (for example, ketoconazole) may increase blood levels of Lunesta and its sedative effects.
Use of Lunesta during pregnancy has not been adequately evaluated. It is unknown if Lunesta is excreted in breast milk. Because many medicines are excreted in breast milk and because the effect of Lunesta on infants has not been studied, breastfeeding is not recommended while taking Lunesta.
What drugs interact with Lunesta?
CNS Active Drugs
- An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol.
- Coadministration of eszopiclone and olanzapine produced a decrease in DSST scores.
- The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug.
Drugs That Inhibit Or Induce CYP3A4
Drugs That Inhibit CYP3A4 (Ketoconazole)
- CYP3A4 is a major metabolic pathway for elimination of eszopiclone. The exposure of eszopiclone was increased by coadministration of ketoconazole, a potent inhibitor of CYP3A4.
- Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly.
- Dose reduction of Lunesta is needed for patient co-administered Lunesta with potent CYP3A4 inhibitors.
Drugs That Induce CYP3A4 (Rifampicin)
- Racemic zopiclone exposure was decreased 80% by concomitant use of rifampicin, a potent inducer of CYP3A4.
- A similar effect would be expected with eszopiclone. Combination use with CYP3A4 inducer may decrease the exposure and effects of Lunesta.
Lunesta side effects list for healthcare professionals
The following are described in more detail in the Warnings and Precautions section of the label:
- Complex Sleep Behaviors
- CNS Depressant Effects and Next-Day Impairment
- Need to Evaluate for Comorbid Diagnoses
- Severe Anaphylactic and Anaphylactoid Reactions
- Abnormal Thinking and Behavioral Changes
- Withdrawal Effects
- Timing of Drug Administration
- Special Populations
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The premarketing development program for Lunesta included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years.
The conditions and duration of treatment with Lunesta varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.
Clinical Trials Experience
Adverse Reactions Resulting In Discontinuation Of Treatment
In placebo-controlled, parallel-group clinical trials in the elderly, 3.8% of 208 patients who received placebo, 2.3% of 215 patients who received 2 mg Lunesta, and 1.4% of 72 patients who received 1 mg Lunesta discontinued treatment due to an adverse reaction. In the 6-week parallel-group study in adults, no patients in the 3 mg arm discontinued because of an adverse reaction. In 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 Lunesta discontinued due to an adverse reaction. No reaction that resulted in discontinuation occurred at a rate of greater than 2%.
Adverse Reactions Observed At An Incidence Of ≥2% In Controlled Trials
Table 1 shows the incidence of adverse reactions from a Phase 3 placebo-controlled study of Lunesta at doses of 2 or 3 mg in nonelderly adults. Treatment duration in this trial was 44 days. The table includes only reactions that occurred in 2% or more of patients treated with Lunesta 2 mg or 3 mg in which the incidence in patients treated with Lunesta was greater than the incidence in placebo-treated patients.
Table 1: Incidence (%) of Adverse Reactions in a 6-Week Placebo-Controlled Study in Nonelderly Adults with Lunesta1
|Lunesta 2 mg
|Lunesta 3 mg
|Body as a Whole|
|Skin and Appendages|
|1 Reactions for which the Lunesta incidence was equal to or less than placebo are not listed on the table, but included the following: abnormal dreams, accidental injury, back pain, diarrhea, flu syndrome, myalgia, pain, pharyngitis, and rhinitis.
* Gender-specific adverse reaction in females
** Gender-specific adverse reaction in males
Adverse reactions from Table 1 that suggest a dose-response relationship in adults include
- viral infection,
- dry mouth,
- rash, and
- unpleasant taste, with this relationship clearest for unpleasant taste.
Table 2 shows the incidence of adverse reactions from combined Phase 3 placebo-controlled studies of Lunesta at doses of 1 or 2 mg in elderly adults (ages 65-86). Treatment duration in these trials was 14 days. The table includes only reactions that occurred in 2% or more of patients treated with Lunesta 1 mg or 2 mg in which the incidence in patients treated with Lunesta was greater than the incidence in placebo-treated patients.
Table 2: Incidence (%) of Adverse Reactions in Elderly Adults (Ages 65-86 Years) in 2-Week Placebo-Controlled Trials with Lunesta1
|Lunesta 1 mg
|Lunesta 2 mg
|Body as a Whole|
|Skin and Appendages|
|Urinary Tract Infection||0||3||0|
|1 Reactions for which the Lunesta incidence was equal to or less than placebo are not listed on the table, but included the following: abdominal pain, asthenia, nausea, rash, and somnolence.|
Adverse reactions from Table 2 that suggest a dose-response relationship in elderly adults include
- dry mouth, and
- unpleasant taste, with this relationship again clearest for unpleasant taste.
These figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice because patient characteristics and other factors may differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contributions of drug and nondrug factors to the adverse reaction incidence rate in the population studied.
Other Reactions Observed During The Premarketing Evaluation Of Lunesta
Following is a list of modified COSTART terms that reflect adverse reactions as defined in the prescribing information and reported by approximately 1550 subjects treated with Lunesta at doses in the range of 1 to 3.5 mg/day during Phase 2 and 3 clinical trials throughout the United States and Canada.
All reported reactions are included except those already listed in Tables 1 and 2 or elsewhere in labeling, minor reactions common in the general population, and reactions unlikely to be drug related. Although the reactions reported occurred during treatment with Lunesta, they were not necessarily caused by it.
Reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions:
- frequent adverse reactions are those that occurred on one or more occasions in at least 1/100 patients;
- infrequent adverse reactions are those that occurred in fewer than 1/100 patients but in at least 1/1,000 patients;
- rare adverse reactions are those that occurred in fewer than 1/1,000 patients. Gender-specific reactions are categorized based on their incidence for the appropriate gender.
Digestive System: Infrequent: anorexia, cholelithiasis, increased appetite, melena, mouth ulceration, thirst, ulcerative stomatitis; Rare: colitis, dysphagia, gastritis, hepatitis, hepatomegaly, liver damage, stomach ulcer, stomatitis, tongue edema, rectal hemorrhage.
Nervous System: Infrequent: agitation, apathy, ataxia, emotional lability, hostility, hypertonia, hypesthesia, incoordination, insomnia, memory impairment, neurosis, nystagmus, paresthesia, reflexes decreased, thinking abnormal (mainly difficulty concentrating), vertigo; Rare: abnormal gait, euphoria, hyperesthesia, hypokinesia, neuritis, neuropathy, stupor, tremor.
Skin and Appendages: Infrequent: acne, alopecia, contact dermatitis, dry skin, eczema, skin discoloration, sweating, urticaria; Rare: erythema multiforme, furunculosis, herpes zoster, hirsutism, maculopapular rash, vesiculobullous rash.
Urogenital System: Infrequent: amenorrhea, breast engorgement, breast enlargement, breast neoplasm, breast pain, cystitis, dysuria, female lactation, hematuria, kidney calculus, kidney pain, mastitis, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, uterine hemorrhage, vaginal hemorrhage, vaginitis; Rare: oliguria, pyelonephritis, urethritis.
In addition to the adverse reactions observed during clinical trials, dysosmia, an olfactory dysfunction that is characterized by distortion of the sense of smell, has been reported during postmarketing surveillance with Lunesta. Because this event is reported spontaneously from a population of unknown size, it is not possible to estimate the frequency of this event.
Lunesta (eszopiclone) is a non-benzodiazepine, oral, sedative drug (“sleeping pill”) used to treat insomnia. Common side effects of Lunesta include headache, drowsiness, dry mouth, dizziness, unpleasant taste, stomach upset, and loss of coordination. Lunesta is a controlled substance. Use of Lunesta during pregnancy has not been adequately evaluated. It is unknown if Lunesta is excreted in breast milk.
Multimedia: Slideshows, Images & Quizzes
Sleep Disorders: Insomnia, Sleep Apnea, and More
Learn about the different types of sleep/wake disorders such as insomnia, narcolepsy, and sleep apnea. Explore the symptoms,...
Sleep Better, Conquer Insomnia
What is insomnia? Insomnia by definition is trouble falling or staying asleep. Insomnia causes are varied. Learn 10 tips on how...
Top Reasons Children Can't Sleep in Pictures
From snoring and nightmares to sleep apnea and even you, see the bad habits that are keeping your child up all night.
20 Tips to Beat Insomnia and Sleep Better
Good sleep hygiene leads to better sleep. Avoid insomnia and sleep better by minimizing stress, exercising, and taking proper...
Sleep: The Best and Healthiest Sleeping Positions for Your Health
What is the best and healthiest sleeping position? Learn ways to say good night to back pain, neck pain, snoring, arthritis, and...
Sleep Health: 20 Facts About Your Biological Body Clock
Biological clocks control much of human biology, including aging, hormones, sleep, fertility, and seasonal cycles. The body clock...
Insomnia Quiz: What Is Insomnia?
Insomnia affects all age groups, and is the most common sleep disorder in the world. There also seems to be a link between...
Sleep Quiz: Sleep Hygiene & Sleep Facts
Take our Sleeping Quiz to learn which sleep disorders, causes, and symptoms rule the night. Trouble falling or staying asleep?...
Sleep Disorders: Dos and Don'ts After a Bad Night's Sleep
You didn’t sleep last night. Now what? Find out from WebMD what to do to make the best of the day and night ahead.
Sleep Disorders: Why You Snore and How to Stop
Maybe you snore, and it keeps your partner up. Or maybe it's so loud it even wakes you up. But it can be more than a nuisance --...
Sleepless? Know the Signs of Sleep Deprivation
Think you may have sleep deprivation? Whether short term or long term, sleep deprivation can cause trouble. From weight gain to...
Sleep Disorders: Myths and Facts About Obstructive Sleep Apnea
Is it just snoring, or is it something more serious? We set the record straight on some myths and facts surrounding obstructive...
Wake-Up Tips: How to Make the Morning Easier
Here are eleven ways from WebMD to bound out of bed when your alarm goes off.
Sleep Disorders: Foods That Help Sleep or Keep You Awake
Need more shut-eye? Your late-night cravings could be keeping you from a good night’s sleep. Should you drink green tea before...
Bed Basics: How to Get Your Best Sleep Ever
Sleep. It seems like the easiest thing in the world. Until it's not. See tips on how to get your best sleep. Our gallery shows...
Sleep Disorders: Ways to Wreck Your Sleep
A lousy night's sleep can mean a bad day at the office. Here are a few things that can get in the way of good rest.
Sleep Cycle: What Happens When You Sleep
Sleep is a mystery to many of us, but scientists know quite a bit about how it affects us. Here's what happens to your body when...
Night Shift: Jobs That Can Ruin Your Sleep
Some jobs can lead to sleep problems like insomnia, especially for graveyard and other shift work. Learn how work can disrupt...
Sleep: Health Benefits of Napping
Napping isn't just for babies. It can be great for adults, too. Learn why.
Related Disease Conditions
16 Early Rheumatoid Arthritis (RA) Signs & Symptoms
Early rheumatoid arthritis (RA) symptoms and signs vary differently from person to person. The most common body parts that are initially affected by RA include the small joints of the hands, wrists, and feet, and the knees and hip joints. Joint inflammation causes stiffness. Warmth, redness, and pain may vary in degree.
What Are the Five Types of Insomnia?
The five types of insomnia are as follows: acute insomnia, chronic insomnia, onset insomnia, maintenance insomnia, and behavioral insomnia of childhood.
12 Early Signs of Arthritis in Hands
Hand arthritis occurs when there is inflammation in one or more joints of the hand and wrist. A few of the common types of arthritis that affect the hands are osteoarthritis, rheumatoid arthritis, post-traumatic arthritis (arthritis as a result of an injury), psoriatic arthritis and gout.
Arthritis (Joint Inflammation)
Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
Second Source article from Government
14 Early Signs of Arthritis in the Legs
Leg arthritis affects the joints of the hips, knees, ankles or feet. The early signs and symptoms of arthritis in the legs include pain, swelling, stiffness, decreased range of motion, trouble walking, fever, bump-like swelling, and other symptoms.
Sleep Disorders (How to Get a Good Night's Sleep)
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep; 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement). The side effects of lack of sleep or insomnia include: Irritability Tiredness Feeling sleepy during the day Concentration or memory problems Lack of sleep and insomnia can be caused by medical conditions or diseases, medications, stress, or pain. The treatment for lack of sleep and insomnia depends upon the cause.
Early Signs and Symptoms of Arthritis in Knuckles
Pain, swelling, and tenderness are usually considered as early signs and symptoms of knuckle arthritis. Tiny bumps pop out on the top knuckles of some of the fingers, and fingers become stiff.
Sleep apnea is defined as a reduction or cessation of breathing during sleep. The three types of sleep apnea are central apnea, obstructive apnea (OSA), and a mixture of central and obstructive apnea. Central sleep apnea is caused by a failure of the brain to activate the muscles of breathing during sleep. OSA is caused by the collapse of the airway during sleep. OSA is diagnosed and evaluated through patient history, physical examination and polysomnography. There are many complications related to obstructive sleep apnea. Treatments are surgical and non-surgical.
What Causes Insomnia?
Insomnia is defined as repeated difficulty with sleep initiation, maintenance, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime impairment. There are three types of insomnia.
11 Home Remedies for Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a long-term disorder that progressively affects many parts of the body. Home remedies, diet, and lifestyle changes can help reduce pain and discomfort associated with RA alongside medical treatment. Home remedies alone cannot effectively treat RA or prevent the progression of the disease.
Insomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up frequently during the night with difficulty returning to sleep; waking up too early in the morning; or unrefreshing sleep. Secondary insomnia is the most common type of insomnia. Treatment for insomnia include lifestyle changes, cognitive behavioral therapy, and medication.
Can Rheumatoid Arthritis Be Caused by Stress?
Rheumatoid arthritis can be caused by and result in stress, as well as other conditions such as gastrointestinal problems (IBD).
Arthritis in Knee: 4 Stages of Osteoarthritis
Painful joint swelling is called arthritis. Osteoarthritis is due to wear and tear of the joints over many years. Arthritis maye develop in any joint, including the fingers, hips and knees. Usually, patients with arthritis feel pain in their joints even after moderate movements. There are four stages of osteoarthritis of the knee.
17 Early Signs of Arthritis in the Back
Arthritis in the back arises due to the inflammation of facet joints in the spine or sacroiliac joints between the spine and the pelvis. Some of the early signs of arthritis in the back include back pain, stiffness, swelling, bone grinding, loss of flexibility, fatigue, muscle spasms and other symptoms.
Insomnia Treatment (Sleep Aids and Stimulants)
Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.
Sleep paralysis is a condition that causes a person to feel as if he or she is awake but is unable to move. Lack of sleep, sleep disorders, use of certain medications, and other factors may be related to sleep paralysis. Sleep paralysis usually does not require treatment; however, treating underlying conditions may help sleep paralysis.
Do You Hallucinate During Sleep Paralysis?
Some people may experience hallucinations during sleep paralysis. The hallucinations may last from a few seconds to a few minutes.
Sleep Disorders in Children and Teenagers
Sleep needs in children and teenagers depend on the age of the child. Sleep disorders in children such as: sleep apnea, parasomnias, confusional arousals, night terrors, nightmares, narcolepsy, and sleepwalking which can affect a child's or teen's sleep. Healthy sleep habits and good sleep hygiene can help your infant, toddler, preschooler, tween, or teenager get a good night's sleep.
What Are the Four Warning Signs of Sleep Apnea?
Sleep apnea is a sleep disorder that can potentially lead to serious systemic health complications. It is a condition that causes a person to intermittently stop breathing during sleep. Warning signs of sleep apnea include snoring, nighttime gasping, intermittent pauses during sleep, and daytime sleepiness.
Does Rheumatoid Arthritis Run in Families?
Rheumatoid arthritis (RA) is an autoimmune disease that tends to run in families. Your likelihood of getting RA, however, is not determined by family history of the disease alone. It is also influenced by environmental factors such as age, obesity and smoking.
What Are the Three Types of Sleep Apnea?
Sleep apnea is a sleep disorder that can potentially lead to serious health complications. In sleep apnea, the person may stop breathing for some time during sleep. The three kinds of sleep apnea are obstructive sleep apnea, central sleep apnea, and mixed sleep apnea.
Do Steroids Help With Arthritis?
Arthritis is the inflammation of one or more joints in the body. The disease is one of the most common chronic health conditions in the United States. Steroids are a class of drugs that reduce inflammation and have a suppressing effect on the immune system.
Sleep Related Breathing Disorders
Sleep-related breathing disorders are characterized by disruptions of normal breathing patterns that only occur during sleep. Snoring and sleep apnea are the most common sleep-related breathing disorders.
What Are 5 Common Risk Factors to Rheumatoid Arthritis?
Rheumatoid arthritis (RA) is an autoimmune disorder (the body's immune system mistakenly attacks its own cells). Certain factors increase the risk of RA.
Do Anti-Inflammatories Help Rheumatoid Arthritis?
Rheumatoid arthritis is a chronic inflammatory disorder. Anti-inflammatory medications can help address symptoms of rheumatoid arthritis.
How to Fall Asleep Fast
If you cannot fall asleep within 20-30 minutes of getting into bed or stay wide awake even after being extremely tired, then here are some tips.
Treatment & Diagnosis
- Child Sleep Solutions
- Sleep Apnea
- Sleep: Getting a Good Night's Sleep -- Michael Breus, PhD
- Sleep Disorders with Kids
- Sleep Disorders in Adults
- Sleep Paralysis
- Sleep Solutions: Michael Breus, PhD
- Sleep and Health for Older Americans -- Sonia Ancoli-Israel, PhD
- Sleep Disorders
- Sleep: Your Child's Sleep Habits and You
- Sleep FAQs
- Insomnia FAQs
- Snoring...A Productivity Problem!
- Sleep: At The Wheel With Sleep Apnea!
- Progressive Muscle Relaxation
- Trouble Sleeping? Insomnia May Be Why
- 10 Tips to Avoid Insomnia and Get a Good Night's Sleep
- 8 Tips on How to Relax and Sleep When Stressed
- Sleep: Are You Sleep Deprived?
- What Is Twilight Sleep in Obstetrics?
- How Can You Sleep if You're Stressed?
- Sleep Apnea Symptoms
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects, drug interactions, and addiction sections courtesy of the U.S. Food and Drug Administration.