"Sleep disorder drugs (hypnotic and sedative drugs) overview
Insomnia, a disorder in which there is difficulty sleeping, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself "...
Lunesta Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Lunesta (eszopiclone) is sedative drug, also called a hypnotic, used to treat insomnia. Lunesta is not available in generic form and should be taken with a full glass of water. Avoid taking Lunesta within 1 hour after eating a high-fat or heavy meal. The high-fat or heavy meal will make it harder for your body to absorb the medication. Stop using Lunesta and call your doctor at once if you have any of these serious side effects: aggression, agitation, changes in behavior, thoughts of hurting yourself, or hallucinations (hearing or seeing things). Less serious side effects may include day-time drowsiness, dizziness, "hangover" feeling, problems with memory or concentration, anxiety, depression, nervous feeling, headache, nausea, stomach pain, loss of appetite, constipation, dry mouth, unusual or unpleasant taste in your mouth, or mild skin rash. This is not a complete list of side effects, and others may occur.
Drug interactions and warnings include: do not drink alcohol while you are taking Lunesta. It can increase some of the side effects, including drowsiness. Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are taking any of the following drugs: rifampin (Rifadin, Rifater, Rifamate, Rimactane); ketoconazole (Nizoral); or antidepressants, narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications. This list is not complete and there may be other drugs that can interact with Lunesta. There are no adequate and well-controlled studies of Lunesta in pregnant women. Lunesta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Lunesta is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lunesta is administered to a nursing woman. A doctor should be consulted both before becoming pregnant and before nursing while taking Lunesta. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, abdominal cramps, vomiting, sweating, or shakiness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Our Lunesta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lunesta in Detail - Patient Information: Side Effects
Eszopiclone may cause a severe allergic reaction. Stop taking eszopiclone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using eszopiclone and call your doctor at once if you have any of these serious side effects:
- aggression, agitation, changes in behavior;
- thoughts of hurting yourself; or
- hallucinations (hearing or seeing things).
Less serious side effects may include:
- day-time drowsiness, dizziness, "hangover" feeling;
- problems with memory or concentration;
- anxiety, depression, nervous feeling;
- nausea, stomach pain, loss of appetite, constipation;
- dry mouth;
- unusual or unpleasant taste in your mouth; or
- mild skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Lunesta (Eszopiclone) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lunesta Overview - Patient Information: Side Effects
This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking eszopiclone.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lunesta (Eszopiclone)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lunesta FDA Prescribing Information: Side Effects
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 non-elderly 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 Non-Elderly Adults with LUNESTA1
|LUNESTA 2 mg
|LUNESTA 3 mg
|Body as a Whole|
|Skin and Appendages|
|Gynecomastia * *||0||3||0|
|1Reactions 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, dizziness, hallucinations, infection, 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) 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|
|1Reactions 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 pain, 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 non-drug 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 introduction to the Adverse Reactions section 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 post-marketing 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.
Read the entire FDA prescribing information for Lunesta (Eszopiclone) »
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