Lunesta (Eszopiclone) | Pharmaceutical Product Information

Product Description

Lunesta is a prescription sedative-hypnotic medication containing eszopiclone. It is used for the treatment of insomnia, including difficulties falling asleep and maintaining sleep.

Eszopiclone works by enhancing inhibitory signaling through the GABA-A receptor system in the central nervous system. This activity produces sleep-promoting and sedative effects. Although Lunesta is not classified as a benzodiazepine, it acts on a related receptor system and may cause drowsiness, impaired alertness, dependence, and withdrawal symptoms.

Lunesta should be used only under the supervision of a qualified healthcare professional and in accordance with the official prescribing information.

What Is Lunesta?

Lunesta is a brand name for eszopiclone, a non-benzodiazepine sedative-hypnotic medication, sometimes referred to as a “Z-drug.”

It is prescribed to eligible patients with insomnia and may help with:

• Difficulty falling asleep

• Difficulty staying asleep

• Frequent nighttime awakenings

• Sleep problems that affect daily functioning

The appropriate treatment depends on the patient’s medical history, sleep symptoms, other medicines, and potential risk factors.

Key Product Information

Mechanism of Action

Eszopiclone interacts with the GABA-A receptor complex, enhancing inhibitory neurotransmission in the central nervous system.

This may result in:

• Reduced time needed to fall asleep

• Improved sleep maintenance

• Increased sleep duration in some patients

• Sedation and reduced central nervous system activity

The precise relationship between receptor activity and the clinical treatment of insomnia is complex. Individual responses and adverse effects vary.

Medical Uses

1. Insomnia

Lunesta is used for the treatment of insomnia, which may involve:

• Difficulty initiating sleep

• Difficulty maintaining sleep

• Repeated nighttime awakenings

• Early waking or insufficient restorative sleep

A healthcare professional should evaluate persistent insomnia for possible underlying causes, such as anxiety, depression, sleep apnea, medication effects, or other medical conditions.

2. Short-Term or Longer-Term Clinical Management

Depending on the patient’s condition and medical evaluation, eszopiclone may be prescribed for a short period or for longer treatment with ongoing review. Long-term use should be carefully assessed because of potential dependence, tolerance, and adverse effects.

Potential Benefits

When used appropriately, Lunesta may help:

• Reduce the time required to fall asleep

• Improve the ability to remain asleep

• Reduce nighttime awakenings

• Increase total sleep time in some patients

• Improve sleep-related functioning

Lunesta does not necessarily resolve the underlying cause of chronic insomnia. Cognitive behavioral therapy for insomnia (CBT-I) and healthy sleep practices may also be recommended.

Dosage and Administration

The appropriate dose depends on:

• Age

• Liver function

• Other medicines being taken

• Individual sensitivity to sedatives

• Response to treatment

• Risk of next-day impairment

The dose must be determined by a healthcare professional. Use the lowest effective prescribed dose and follow the official product instructions.

Important Administration Precautions

• Take Lunesta only as prescribed.

• Take it immediately before going to bed.

• Use it only when you can remain in bed for a full night.

• Do not take another dose during the same night unless specifically directed by your clinician.

• Avoid taking it with or immediately after a heavy meal because food may delay its effect.

• Do not combine it with alcohol or other sedative medicines.

• Do not drive or operate machinery if you experience next-day drowsiness or impairment.

• Do not change the prescribed dose without medical advice.

Common Side Effects

Possible side effects of Lunesta include:

• Unpleasant or metallic taste

• Dry mouth

• Headache

• Drowsiness

• Dizziness

• Fatigue

• Reduced alertness

• Nausea

• Sleepiness the following day

• Impaired coordination

An unpleasant taste or altered taste sensation is a particularly recognized adverse effect of eszopiclone.

Serious Warnings and Risks

1. Complex Sleep Behaviors

Eszopiclone may cause complex sleep behaviors, including activities performed while not fully awake, such as:

• Sleepwalking

• Sleep driving

• Preparing or eating food

• Making phone calls

• Other activities that may not be remembered afterward

These behaviors can cause serious injury or death.

Stop using the medicine and contact a healthcare professional immediately if a complex sleep behavior occurs, unless the clinician provides different instructions.

2. Next-Day Impairment

Lunesta can affect:

• Reaction time

• Coordination

• Judgment

• Attention

• Memory

• Driving ability

Impairment may occur even when the patient feels awake. The risk can increase with higher doses, insufficient sleep, alcohol, or other sedating medicines.

3. Central Nervous System and Respiratory Depression

The sedative effects of eszopiclone may be increased when combined with:

• Opioids

• Alcohol

• Benzodiazepines

• Other sleeping medicines

• Sedating antihistamines

• Other central nervous system depressants

Severe drowsiness, slow breathing, difficulty waking, or loss of consciousness requires emergency medical assistance.

4. Dependence and Withdrawal

Eszopiclone may cause tolerance and physical dependence, particularly with prolonged use or misuse. Stopping regular treatment may result in:

• Rebound insomnia

• Anxiety

• Irritability

• Sleep disturbances

• Other withdrawal symptoms

Consult a healthcare professional before stopping regular treatment.

5. Psychiatric and Behavioral Effects

Some patients may experience:

• Confusion

• Agitation

• Hallucinations

• Unusual behavior

• Mood changes

• Worsening depression

Report significant mental or behavioral changes to a healthcare professional.

Drug Interactions

Tell your doctor or pharmacist about all prescription medicines, over-the-counter medicines, and supplements you use.

Contraindications and Precautions

Inform your healthcare professional if you have:

• A history of complex sleep behaviors after taking sleep medication

• Sleep apnea or other breathing disorders

• Liver disease

• A history of substance misuse or dependence

• Depression or other mental health conditions

• Suicidal thoughts or previous suicidal behavior

• A history of falls or balance problems

• Pregnancy or plans to become pregnant

• Breastfeeding

• Allergies to eszopiclone or any formulation ingredient

Older adults may have an increased risk of confusion, falls, and impaired coordination.

Storage Information

Store Lunesta according to the official product packaging and prescribing information.

General precautions include:

• Keep the medication in its original packaging.

• Store it away from excessive heat and moisture.

• Keep it out of reach of children.

• Do not use the medicine after its expiry date.

• Do not share prescription medication.

• Dispose of unused medication through an approved disposal service.

Frequently Asked Questions

What is Lunesta used for?

Lunesta contains eszopiclone and is prescribed for insomnia, including difficulty falling asleep and maintaining sleep.

Is Lunesta a benzodiazepine?

No. Eszopiclone is classified as a non-benzodiazepine sedative-hypnotic, commonly called a Z-drug. It acts on the GABA-A receptor system and can still cause sedation, dependence, and withdrawal.

Can Lunesta cause dependence?

Yes. Eszopiclone may cause tolerance, physical dependence, or misuse, especially when used for extended periods or outside prescribed instructions.

Can Lunesta be taken with alcohol?

No. Alcohol can intensify the sedative effects of eszopiclone and increase the risk of dangerous sleep behaviors, impaired coordination, and breathing problems.

Can Lunesta be taken with opioids?

Combining eszopiclone with opioids may increase the risk of severe sedation and respiratory depression. The combination should only be used under specific medical direction and monitoring.

Why does Lunesta cause a metallic taste?

A bitter, unpleasant, or metallic taste is a recognized side effect of eszopiclone. Inform your healthcare professional if the symptom is persistent or difficult to tolerate.

How long can Lunesta be used?

The duration depends on the patient’s condition, treatment response, and clinical risk factors. Continued use should be reviewed regularly by a healthcare professional.

Should Lunesta be stopped suddenly?

If you have been taking Lunesta regularly, consult your healthcare professional before stopping. Abrupt discontinuation may cause rebound insomnia or withdrawal symptoms.