Lunesta (Eszopiclone) - Summary

LUNESTA SUMMARY

LUNESTA™ (eszopiclone) TABLETS
1 mg, 2 mg, 3 mg

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.

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LUNESTA NEWS HIGHLIGHTS

Media Articles Related to Lunesta (Eszopiclone)

Sepracor Provides Update On Clinical Trials For SEP-225289 And LUNESTA(R) Pediatrics
Source: Health News from Medical News Today [2009.07.02]
Sepracor Inc. (Nasdaq: SEPR) announced that it has completed the analysis and validation of the preliminary results of a Phase II, 514-patient study evaluating the efficacy and safety of SEP-225289 for the treatment of Major Depressive Disorder, including patients with melancholic and atypical features.

2-Week Course Of Sleep Aid Increases CPAP Adherence In OSA Patients At 6 Months
Source: Compliance News From Medical News Today [2009.05.18]
New research suggests that patients newly diagnosed with obstructive sleep apnea (OSA) who use a short-course of the sleep aid, eszopiclone, when beginning continuous positive airway pressure (CPAP) therapy, are more adherent with therapy in six months. The findings were presented at the American Thoracic Society's International Conference in San Diego on May 17. OSA is a common disorder that leads to multiple adverse effects on health and quality of life.

Scientists Search For Sleepless Souls Suffering Lifelong Insomnia, Scotland
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.21]
Most people have experienced the odd sleepless night before a crucial exam, a job interview or before going on holiday, but few people get by with just a couple of hours of sleep a day, every day. Terry McKinnes, 54, of Falkirk, is one of the unfortunate people who suffers from idiopathic insomnia who feels she has spent almost her entire life awake.

APSS: Nonsedating Sleep Aid Improves Insomnia and Performance (CME/CE)
Source: MedPage Today Psychiatry [2009.06.18]
SEATTLE (MedPage Today) -- An investigational nonsedating medication improved sleep maintenance without residual next-day effects in a placebo-controlled trial of patients with chronic insomnia.

Frontal Cerebral Hypothermia Found To Be Possible New Treatment For Insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.14]
Insomnia is associated with increased frontal cerebral metabolism during Rapid Eye Movement (REM) sleep. Cerebral hypothermia, or cooling of the brain, has been found to reduce cerebral metabolism in other medical conditions, but its effects in insomnia are unknown. In a University of Pittsburgh study by Eric Nofzinger, M.D.

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Published Studies Related to Lunesta (Eszopiclone)

Eszopiclone improves overnight polysomnography and continuous positive airway pressure titration: a prospective, randomized, placebo-controlled trial. [2008.09.01]
STUDY OBJECTIVES: To assess whether premedication with eszopiclone [generic for Lunesta] would improve sleep duration and continuity during polysomnography, thereby improving the quality of diagnostic and CPAP titration studies... CONCLUSION: Pretreatment with eszopiclone improves the quality of polysomnography and CPAP titration and decreases the need to repeat studies. Given the ever-growing demand for polysomnography and the need to improve efficiency, the routine use of nonbenzodiazepines as premedication for polysomnography should be considered.

Next-day cognition, psychomotor function, and driving-related skills following nighttime administration of eszopiclone. [2008.07]
OBJECTIVE: To evaluate next-day driving ability, as assessed by brake reaction time (BRT), and cognitive/psychomotor function following nighttime administration of 3 mg eszopiclone [generic for Lunesta]... CONCLUSIONS: Nighttime administration of 3 mg eszopiclone improved objective and subjective sleep measures in patients with insomnia (and subjective sleep measures in healthy patients) and did not impair next-day driving-related skills or measures of cognition in either study population relative to placebo. Copyright 2008 John Wiley & Sons, Ltd.

A polysomnographic placebo-controlled evaluation of the efficacy and safety of eszopiclone relative to placebo and zolpidem in the treatment of primary insomnia. [2008.06.15]
STUDY OBJECTIVES: To evaluate the polysomnographic efficacy and the safety of a range of doses of eszopiclone [generic for Lunesta] relative to placebo in patients with primary insomnia. Zolpidem 10 mg was included as an active control... CONCLUSIONS: Relative to placebo, all active treatments were effective in reducing LPS and increasing SE. Eszopiclone 3 mg was significantly different from placebo on the 3 PSG measures of sleep maintenance (WASO, WTDS, and NAW). Significant differences between zolpidem 10 mg and eszopiclone (2 mg or 3 mg) were not observed for PSG-measured outcomes, although the study was not powered to detect differences between the active drug conditions.

Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. [2008.05]
CONTEXT: Insomnia and generalized anxiety disorder (GAD) are prevalent disorders that may coexist. OBJECTIVE: To determine the efficacy of eszopiclone [generic for Lunesta] combined with escitalopram oxalate in treating insomnia comorbid with GAD... CONCLUSIONS: Coadministration of eszopiclone and escitalopram was well tolerated and associated with significantly improved sleep, daytime functioning, anxiety, and mood in patients with insomnia and GAD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00235508.

Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations. [2007.08.01]
STUDY OBJECTIVES: To evaluate 6 months' eszopiclone [generic for Lunesta] treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations... CONCLUSIONS: This is the first placebo-controlled investigation to demonstrate that long-term nightly pharmacologic treatment of primary insomnia with any hypnotic enhanced quality of life, reduced work limitations, and reduced global insomnia severity, in addition to improving patient-reported sleep variables.

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Clinical Trials Related to Lunesta (Eszopiclone)

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. Moreover, it is hypothesized that changes will persist for two weeks following discontinuation of eszopiclone.

Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban [Recruiting]
Objectives:

The primary objective of this study is to determine the efficacy of eszopiclone at treating sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking cessation.

Sleep disturbances are a significant problem for smokers who are trying to quit smoking. Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents used to aid smoking cessation (e. g., pharmacotherapies) may disrupt sleep. Lunesta (eszopiclone) is a medication that has been approved by the FDA to treat insomnia. Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine withdrawal-related symptoms of sleep disturbance.

This study will be 7 weeks duration. All participants will begin taking Zyban at the beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2. Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the target quit date at the beginning of week 2. All subjects will receive eight (8) weekly sessions of brief individual supportive smoking cessation counseling.

Hypothesis:

It is hypothesized that significantly fewer sleep problems will be reported by participants taking Lunesta as compared to placebo. Specifically, it is expected that participants taking Lunesta will report less difficulty falling and staying sleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.

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.

The Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Alcohol Dependence [Recruiting]
Eszopiclone will lead to significantly greater improvement in sleep compared to placebo in patients with insomnia that is associated with alcohol dependence in the post-withdrawal period. The primary outcome measure will be self-reported total sleep time (TST). A secondary hypothesis is that the treatment of insomnia with eszopiclone in this population will lead to a statistically significant improvement in reduced drinking behaviors and improved overall daytime functioning as compared to placebo.

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder [Recruiting]
The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.

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LUNESTA 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:		ptsd/insomnia
Dosage & duration:		3mg taken nightly for the period of ongoing
Other conditions:		n/a
Other drugs taken:		antidepressant - Effexor
		Reported Results
Benefits:		For years I was sleep deprived due to working conditions. Rarely would I enjoy the luxury of a full night sleep. Typically I would take hours to get to sleep and had extreme difficulty remaining asleep. Dreams were too realistic and often I would be more tired in the morning than upon retiring to bed. Taking Lunesta has allowed me not only to get to sleep but return to sleep. If I wake in the middle of the night, for example to go to the bathroom, I am awake and not stumbling. The vivid dreams are gone and I have experienced no groggy or hungover symptoms that you sometimes hear of when taking sleep medication. It has truly changed my life and I am so grateful for my Dr. for his prescription.
Side effects:		It has been over a year and I have yet to see any side effects, other than increasing the dosage from 2-3mg.
Comments:		One tablet, taken each night when I was already in bed and ready for sleep.

Lunesta review by 31 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Insomnia/difficulty sleeping
Dosage & duration:		2 mg taken every night as needed for sleep for the period of over a month
Other conditions:		PKD, Insomnia,
Other drugs taken:		Only multiple vitamins and OTC medicatinos
		Reported Results
Benefits:		I was finally able to easily fall asleep and for the most part remain asleep for the entire night. The sleep was more refreshing and I woke up without the typical sleeping pill "hang-over". Even while falling asleep you I didn't feel like I was all of a sudden blind-sided by a brick wall and forced to sleep. This feels much more natural and real than other medications I have tried.
Side effects:		At first, very vivid and biazarre nightmares and dreams. These gradually became less severe and less violent or frightening and now I dream normally (for me) and have no other side effects that I have become aware of yet.
Comments:		The Lunesta was prescribed to me by my nephrologist as a part of treatment for continued insomnia. This has been a long term problem and in the past I have tried Remeron (which should be banned...horrible side effects and hangovers), Ambien, which is also very good and Ambien CR...that was wonderful. Currently I am happy with this treatment.

Lunesta review by 51 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Insomnia
Dosage & duration:		2mg taken 1day for the period of 1day
Other conditions:		GAD
Other drugs taken:		Lexapro 5mg
		Reported Results
Benefits:		None
Side effects:		Bad Taste but not as bad a most people say
Comments:		Took 2mg for the first time ever (first ever sleep med) on an empty stomach and went to bed at 9:30 Got up at 11:30 and am typing this. I feel alitte sleepy (yawns) but it obviously did zip aliviate onset insomnia.