Lunesta (Eszopiclone) - Summary

LUNESTA SUMMARY

LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class.

LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.

The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study, at the end of both 2-week studies and at the end of the 6-month study.

See all Lunesta indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Lunesta (Eszopiclone)

Relationship Between Sleep Duration And Suicidal Thoughts In People With Insomnia.
Source: Health News from Medical News Today [2013.05.17]
Results of a new study show that every one-hour increase in sleep duration was associated with a 72 percent decrease in the likelihood of moderate or high suicide risk, in comparison with low risk. Data were adjusted for age, gender, race/ethnicity, education and age of onset of sleep difficulties. "We were surprised by the strength of the association between sleep duration and suicide risk," said primary author Linden Oliver, MA, clinical research coordinator for the University of Pennsylvania Behavioral Sleep Medicine Research Program in Philadelphia, Pa...

Insomnia Can Lead To Future Hospitalization And Increased Health Service Use
Source: Seniors / Aging News From Medical News Today [2013.05.14]
Having trouble falling or staying asleep? According to a new study led by a team of researchers at the Johns Hopkins Bloomberg School of Public Health, insomnia may be an important indicator of future hospitalization among middle-aged and older adults...

A Woman's Risk Of Heart Disease May Be Increased By Insomnia And Disrupted Sleep During Menopause
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2013.05.13]
Insomnia and other sleep disturbances are common among perimenopausal and postmenopausal women and may increase their risk of coronary heart disease (CHD) and cardiovascular disease (CVD)...

Making Sense Of The Neurobiology Of Restless Legs Syndrome And Related Insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2013.05.09]
Johns Hopkins researchers believe they may have discovered an explanation for the sleepless nights associated with restless legs syndrome (RLS), a symptom that persists even when the disruptive, overwhelming nocturnal urge to move the legs is treated successfully with medication...

Insomnia May Raise Risk of Heart Attack, Stroke
Source: MedicineNet Hyperthyroidism Specialty [2012.11.05]
Title: Insomnia May Raise Risk of Heart Attack, Stroke
Category: Health News
Created: 11/4/2012 8:35:00 PM
Last Editorial Review: 11/5/2012 12:00:00 AM

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Published Studies Related to Lunesta (Eszopiclone)

Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies. [2011.12]
PURPOSE: Patients with malignancy sometimes develop painful mucositis and require patient-controlled analgesia (PCA) to treat their pain. Pain disrupts sleep and there is some evidence that analgesic medications also disrupt sleep. This study examined whether treatment with the sedative hypnotic eszopiclone could improve self-reports of sleep, fatigue, and pain as well as decrease opioid self-administered via PCA... CONCLUSION: Sedative hypnotic agents improve sleep and analgesia even in the setting of considerable pain and discomfort.

Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomized, double-blind, placebo-controlled trial. [2011.07]
CONCLUSIONS: This study provides initial evidence that pharmacotherapy with eszopiclone may be associated with short-term improvement in overall PTSD severity as well as associated sleep disturbance. Longer, more definitive study of eszopiclone in PTSD is warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00120250. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. [2011.04]
CONCLUSIONS: In this post hoc analysis of patients with insomnia and comorbid anxious depression derived from 2 trials, 8 weeks of eszopiclone therapy coadministered with an SSRI resulted in significantly greater improvements in insomnia, significantly greater reductions in HDRS-17 total score, and significantly greater HDRS-17 response rates compared with placebo coadministration. There were no significant differences in response rates (when insomnia items were excluded) and remission rates, as well as in anxiety/somatization scores. Further research is warranted to determine whether these modest antidepressant effects can be replicated, and anxiolytic effects demonstrated, when evaluated in a prospective manner. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Treatment of insomnia in Parkinson's disease: a controlled trial of eszopiclone and placebo. [2010.08.15]
Parkinson's disease (PD) is a common neurodegenerative disease affecting up to 1 million individuals in the United States. Sleep disturbances, typically in sleep maintenance, are found in up to 88% of these individuals and are associated with a variety of poor outcomes... Definitive trials of the treatment of sleep disorders in this population are warranted.

Economic outcomes of eszopiclone treatment in insomnia and comorbid major depressive disorder. [2010.03]
BACKGROUND: Eszopiclone is effective for the treatment of insomnia in patients with insomnia and comorbid major depressive disorder (MDD). Both conditions impose significant economic burden, with the US societal cost of depression estimated at USD 50 billion annually... IMPLICATIONS FOR FURTHER RESEARCH: The residual efficacy observed in the clinical trial following the discontinuation of co-therapy should be explored further to determine whether intermittent treatment with ESZ+FLX is a cost-effective strategy.

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Clinical Trials Related to Lunesta (Eszopiclone)

Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone [Recruiting]
Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of sleep problems and their impact on the life of these individuals, there has been, until recently, little research focus on the problem. This will be a multi-site, double blind, placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks. Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis is that eszopiclone will be superior to placebo for the treatment of insomnia in patients with Parkinson's disease

Eszopiclone for the Treatment of Posttraumatic Stress Disorder [Recruiting]
The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep disturbance. The investigators will also examine the impact of treatment on sleep patterns, memory recall bias, and level of inflammatory markers (cytokines). The investigators predict eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms, memory recall bias, and level of inflammatory markers.

The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia [Recruiting]
The study will examine the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. The hypothesis is that levels of glutamine and glutamate will be increased in women receiving eszopiclone compared to those receiving placebo. The antidepressant effect of the medication combination will also be assessed.

Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients [Recruiting]
This study is to see the how well Lunesta (Eszopiclone), a sleep drug, will work in people living in a nursing home and have trouble sleeping. We think that people taking Lunesta will sleep much better than when they are not taking sleeping aid. We also think it will be easy for people in the nursing home to take Lunesta.

As a part of this study, we will do several things to record how people sleep including measuring how long someone sleeps in bed at night using a wristwatch type piece of equipment and doing a sleep study called Polysomnography. The Polysomnography will be done in the nursing home and is usually doesn't interrupt sleep. We will also observe people to see how they behave, sleep, their moods, how they think and balance in the daytime.

At the beginning, we will check to see if people have trouble sleeping, then each person will be put into one of two groups randomly. During the first two weeks, group one will be given Lunesta for 6 days, three days the first week and three days the second week. At the same time, group two will get a placebo (something that is not a drug) for 6 days, three days the first week and three days the second week. The third week, no one will get study drugs or placebo. Week four and five, group two will receive Lunesta and group one will receive the placebo. Research staff will be watching carefully for any changes during the whole study.

We believe that Lunesta will possibly improve nighttime sleep and as a result, improve daytime behaviors including mood, balance, activities, thinking and reduce daytime sleepiness.

Effects of Eszopiclone on Sleep and Memory in Schizophrenia [Not yet recruiting]
The investigators will test the hypothesis that the sleep medication, eszopiclone, can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by comparing sleep and performance in participants taking eszopiclone to participants taking placebo. The investigators will study healthy subjects and patients with schizophrenia taking atypical antipsychotic medications.

more trials >>

Reports of Suspected Lunesta (Eszopiclone) Side Effects

Drug Ineffective (16),  Insomnia (15),  Somnolence (7),  Agitation (6),  Fatigue (6),  Depression (6),  Anxiety (6),  Middle Insomnia (6),  Somnambulism (6),  Confusional State (5), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Lunesta review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		insomnia
Dosage & duration:		5mg taken every night for the period of 1 yr
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I have trouble sleeping -- I usually toss and turn all night, sleep a couple of hours and wake up. Normally, I never get a complete night's rest. After my doctor prescribed Lunesta, it was the first time in a very long time, that I was able to sleep from the time I laid my head on the pillow until my alarm sounded in the morning.
Side effects:		I had no side effects from using Lunesta. I felt refreshed in the morning without that groggy feeling or "hang over" like feeling.
Comments:		The treatment involved taking one pill in the evening right before bed. Lunesta works relatively fast, so you do not want to take it unless you are going right to bed because you become drowsy within 10 minutes.

Lunesta review by 41 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		insomnia
Dosage & duration:		3 mg taken every night for the period of 1 year
Other conditions:		anxiety
Other drugs taken:		none
		Reported Results
Benefits:		Lunesta definitely put me to sleep and kept me asleep until morning.
Side effects:		There was a hangover from the medication well into the morning hours after waking.
Comments:		For years I had suffered with insomnia until my doctor prescribed Lunesta in a 3mg dose. It worked very well putting me to sleep and I did not wake until morning. Unfortunately I could sleep 10 - 12 hours and still wake up with a hangover from the medicine. Sometimes a half of a pill would do but I would still have somewhat of a hangover although not as bad. Now I only take during times of stress when sleeping is more important than any of the side effects.

Lunesta review by 33 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Insomina
Dosage & duration:		3mg taken 1 daily for the period of 1 day
Other conditions:		Alpha 1 Antitrpsin Disorder
Other drugs taken:		Prolastin
		Reported Results
Benefits:		NONE
Side effects:		HORRIABLE taste in mouth with 15 minutes of taking it. Even breathing tasted bad as when the air hit my mouth and airway the taste was intensified. I tried to drink water to get rid of the taste and promptly threw up the taste was so bad. Within half an hour of taking the pill I developed a red rash on my face, and in an hour had a full blown lights and floaties migraine. To top it all of my insomonia was actually MADE worse. Two hours after taking the pill I am more awake and alert then I was BEFORE taking it.
Comments:		This is by far the worst medication I have ever taken. I got no help, in fact the problem got much worse and the side effects were unbearable!