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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Lunesta (Eszopiclone)

Stress, Bad Bedtime Habits Cause Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.07.27]
Title: Stress, Bad Bedtime Habits Cause Insomnia
Category: Health News
Created: 7/25/2009 7:00:00 AM
Last Editorial Review: 7/27/2009

Pills Plus Psychotherapy Can Beat Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.05.20]
Title: Pills Plus Psychotherapy Can Beat Insomnia
Category: Health News
Created: 5/20/2009 2:00:00 AM
Last Editorial Review: 5/20/2009

Insomnia
Source: MedicineNet Biorhythms Specialty [2009.03.03]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005
Last Editorial Review: 3/3/2009

Insomnia Treatment: Sleep Aids and Stimulants
Source: MedicineNet Narcolepsy Specialty [2009.01.14]
Title: Insomnia Treatment: Sleep Aids and Stimulants
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 1/14/2009

Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Source: MedicineNet temazepam Specialty [2008.06.05]
Title: Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Category: Doctor's Views
Created: 6/14/2005
Last Editorial Review: 6/5/2008

more news >>

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 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... 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 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 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 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.

more studies >>

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.

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.

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

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.

more trials >>

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 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		insomnia
Dosage & duration:		3mg taken daily for the period of 3 weeks
Other conditions:		irritability
Other drugs taken:		none
		Reported Results
Benefits:		I started having insomnia due to some family issues and had to start taking sleeping pills. With the help of Lunesta I could usually get up to 5 hours of sleep at night on most nights, but then suddenly it stopped working. I could not fall asleep and had to switch to Ambien CR.
Side effects:		Bitter taste in the mouth next morning. Bitter taste in the mouth next morning. Bitter taste in the mouth next morning. Bitter taste in the mouth next morning. Bitter taste in the mouth next morning. Bitter taste in the mouth next morning. Bitter taste in the mouth next morning. Bitter taste in the mouth next morning.
Comments:		It worked for several nights, then suddenly stopped working: I could not fall asleep and had to switch to Ambien CR. It worked for several nights, then suddenly stopped working: I could not fall asleep and had to switch to Ambien CR. It worked for several nights, then suddenly stopped working: I could not fall asleep and had to switch to Ambien CR. It worked for several nights, then suddenly stopped working: I could not fall asleep and had to switch to Ambien CR. It worked for several nights, then suddenly stopped working: I could not fall asleep and had to switch to Ambien CR.

Lunesta review by 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		sleeplessness
Dosage & duration:		1 pill taken 30 minutes before bed for the period of 6 months
Other conditions:		Gastric Reflux
Other drugs taken:		Nexium
		Reported Results
Benefits:		I was able to sleep
Side effects:		Violent nightmares. Sleep-walking. Two of the many examples: Got up and took a bath with NO recollection. Another time got up and BAKED COOKIES...made the dough, baked the cookies, cleaned up the kitchen, put the cookies in the jar....with not ONE recollection I did it.
Comments:		Was told I fall into the low percentage of people who have these same side-effects. Taken off Lunesta and cannot take Ambian for the same reasons. Tried Melatonin, 5mg a night...works like a charm and I haven't been in the kitchen baking!