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Description

Generic Name

Eszopiclone

Active Ingredient

Eszopiclone

Chemical Name

Eszopiclone is chemically described as (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate.

Eszopiclone is a white to light-yellow crystalline solid. It is very slightly soluble in water, slightly soluble in ethanol, and freely soluble in dichloromethane. It is the S-isomer of zopiclone and has a molecular weight of 388.81.

Medication Classification

Lunesta (eszopiclone) is a non-benzodiazepine sedative-hypnotic. It is thought to work by interacting with GABA-receptor complexes in the brain, which calms nerve activity and promotes sleep. Although it is not a benzodiazepine, it acts on similar receptor sites.

Eszopiclone is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indication

Lunesta is indicated for the treatment of insomnia in adults. It may help patients fall asleep faster and stay asleep longer.

Dosage Forms and Available Strengths

• Dosage Form: Oral (film-coated) tablets
• Route of Administration: Oral
• Available Strengths: 1 mg, 2 mg, and 3 mg

Inactive Ingredients

Inactive ingredients vary by manufacturer. Tablets may contain calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, triacetin, and colorants such as FD&C Blue #2 or iron oxides. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Lunesta exactly as prescribed by your healthcare provider. Your provider will use the lowest effective dose for your situation. Do not change your dose or stop taking it without medical guidance.

How to Take Lunesta

• Swallow the tablet whole with water.
• Take Lunesta right before you get into bed, not sooner.
• Take it only when you are able to stay in bed for a full night of sleep, generally 7 to 8 hours, before you need to be active again.
• Do not take more than one dose in a single night.
• Do not take more than prescribed, and do not take it more often than directed.

Recommended Doses

• The usual starting dose is 1 mg taken immediately before bedtime.
• Depending on your response and how well you tolerate the medication, your provider may increase the dose to 2 mg or 3 mg.
• Lower doses are recommended for older adults and patients with liver problems, or when taken with certain other medicines.

Food and Alcohol Considerations

• Do not take Lunesta with or right after a high-fat or heavy meal. Doing so can slow how quickly it works and reduce its effect on helping you fall asleep.
• Avoid alcohol while taking Lunesta. Combining the two increases sedation and the risk of dangerous side effects, including breathing problems.

Missed Dose Instructions

Lunesta is taken only at bedtime when needed for sleep, so it does not follow a fixed daytime schedule.

• Take it only if you have a full night (7 to 8 hours) available for sleep.
• If you missed your bedtime dose and it is too late to allow a full night of sleep, skip it and resume the next night.
• Do not take a double dose to make up for a missed one.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children.

Disposal

Because Lunesta is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal.

Special Instructions

Children: The safety and effectiveness of Lunesta have not been established in children. It is not recommended for pediatric use. Keep the medication out of the reach of children, as accidental ingestion can be dangerous. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of eszopiclone, including sedation, dizziness, and unsteadiness, which can raise the risk of falls. A provider will usually start at a lower dose and monitor closely.

Patients with Liver Problems: Use with caution. A lower dose is recommended for patients with severe liver problems, since eszopiclone is processed by the liver and its effects may last longer.

Caregivers: Give the medication exactly as prescribed. Watch for unusual nighttime behaviors, excessive sleepiness, confusion, slowed or shallow breathing, or trouble waking the patient, and seek emergency care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• In most cases, Lunesta can be stopped without a taper, but talk to your provider before stopping if you have used it regularly for a long time.
• Stopping suddenly after prolonged use may cause mild withdrawal symptoms, such as anxiety, unusual dreams, nausea, or trouble sleeping (rebound insomnia).
• Rebound insomnia, where sleep problems briefly return or worsen, may occur for a night or two after stopping.
• Tell your provider if withdrawal symptoms occur so your care can be adjusted.

Overdose Warning

An overdose of Lunesta can be serious and may be fatal, especially when combined with opioids, alcohol, or other central nervous system (CNS) depressants. Symptoms of overdose may include:

• Extreme drowsiness or difficulty staying awake
• Confusion
• Slowed or shallow breathing
• Loss of coordination
• Reduced reflexes
• Loss of consciousness or coma

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Flumazenil may be considered in some cases to reverse the sedative effects, and treatment focuses on supporting breathing and circulation.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Lunesta and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Complex sleep behaviors: Doing activities while not fully awake, such as driving, making or eating food, making phone calls, or having sex, with no memory of the event. These behaviors can occur even at recommended doses and can be dangerous or fatal.
• Severe allergic reactions (anaphylaxis and angioedema): Swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; hives; or a feeling of the throat closing.
• Abnormal thinking and behavior changes: Confusion, agitation, hallucinations, worsening of aggression, or acting unusually.
• Next-morning impairment: Continued drowsiness, slowed reaction time, or reduced alertness the day after taking the medication, which can affect driving and other activities.
• Depression or suicidal thoughts: New or worsening depression, or thoughts of harming yourself.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Unpleasant or bitter taste in the mouth
• Headache
• Dizziness
• Daytime drowsiness or sleepiness (somnolence)
• Dry mouth

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Complex Sleep Behaviors

• Complex sleep behaviors, including sleepwalking, sleep-driving, and engaging in other activities while not fully awake, have occurred with eszopiclone. These events can happen after the first dose or after continued use.
• Some cases have resulted in serious injuries or death.
• These behaviors can occur at recommended doses, with or without alcohol or other CNS depressants.
• Discontinue Lunesta immediately if you experience a complex sleep behavior.
• Lunesta is contraindicated in patients who have previously experienced a complex sleep behavior with eszopiclone.

Conditions to Disclose to Your Healthcare Provider

Before taking Lunesta, tell your healthcare provider if you have or have had any of the following:

• Liver problems
• Breathing problems, such as chronic obstructive pulmonary disease (COPD) or sleep apnea
• Depression, mood problems, or thoughts of suicide
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• A history of sleepwalking or other complex sleep behaviors
• Kidney problems
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Lunesta if you:

• Have previously experienced a complex sleep behavior (such as sleep-driving) while taking eszopiclone
• Have a known hypersensitivity to eszopiclone or any component of the formulation. Reactions have included anaphylaxis and angioedema.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• CNS depressants: Opioids, other sedatives, tranquilizers, muscle relaxants, and certain antihistamines can add to drowsiness and breathing problems. A dose reduction may be needed.
• Alcohol: Increases sedation and the risk of dangerous side effects. Avoid alcohol while taking Lunesta.
• Strong CYP3A4 inhibitors: Drugs such as ketoconazole, itraconazole, clarithromycin, nefazodone, and ritonavir can raise eszopiclone levels and increase the risk of side effects. A lower dose may be required.
• CYP3A4 inducers: Drugs such as rifampin may lower eszopiclone levels and reduce its effect.
• Other sedating medicines: Combining Lunesta with other sleep aids or sedating drugs is not recommended.

Monitoring Requirements

Your healthcare provider may monitor:

• Whether your insomnia improves and whether continued treatment is needed
• Signs of next-morning impairment, such as drowsiness or slowed reaction time
• Any complex sleep behaviors
• New or worsening depression, mood changes, or suicidal thoughts
• Signs of tolerance, dependence, or misuse
• Liver function in patients with liver problems, as clinically appropriate

Abuse, Dependence, and Misuse Warnings

Lunesta is a Schedule IV controlled substance.

• Eszopiclone may be a target for people who abuse prescription medicines.
• Physical and psychological dependence can develop, particularly with higher doses or prolonged use.
• Tolerance may develop, meaning the medication may become less effective over time.
• Do not increase your dose on your own.
• Do not sell or give away Lunesta. Doing so may harm others and is against the law.

Long-Term Use Considerations

• Lunesta is generally intended for the treatment of insomnia over a limited period. Your provider should periodically reassess whether you still need it.
• Insomnia that does not improve within 7 to 10 days of treatment, or that worsens, may point to another underlying condition that needs evaluation.
• Rebound insomnia may occur for a night or two after stopping the medication.
• Report any new or worsening mood changes, sleep behaviors, or daytime impairment during treatment.

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Patient Counseling Information

Safe Medication Use

• Take Lunesta exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Take it only right before bed and only when you can stay in bed for a full 7 to 8 hours.
• Do not take Lunesta with or right after a high-fat meal, as this can reduce its effect.
• Do not stop taking it or change your dose without talking to your provider first.
• Do not share Lunesta with anyone else. Sharing is dangerous and against the law.
• Keep it in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Complex sleep behaviors: Stop taking Lunesta and tell your provider right away if you learn that you have done activities while asleep, such as driving, eating, or making phone calls with no memory of them.
• Driving and next-morning impairment: Lunesta can affect your alertness, coordination, and reaction time, sometimes into the next day. Do not drive or operate heavy machinery until you know how it affects you and are fully awake.
• Alcohol: Do not drink alcohol while taking Lunesta. The combination increases sedation and the risk of serious side effects.
• Other sedating medicines: Do not take Lunesta with opioids or other CNS depressants unless directed by your provider.
• Mood changes: Watch for new or worsening depression, anxiety, or thoughts of self-harm, and report these to your provider right away.
• Pregnancy: Tell your provider if you are pregnant or plan to become pregnant, as this medication can affect your baby.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Learn that you have carried out activities while not fully awake, such as sleep-driving, with no memory of them
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing or swallowing
• Have new or worsening depression, anxiety, or thoughts of harming yourself
• Notice abnormal thinking or behavior, confusion, agitation, or hallucinations
• Feel very drowsy, slowed, or less alert the day after taking the medication
• Have slow, shallow, or difficult breathing, or extreme sleepiness you cannot fight off
• Find that your insomnia does not improve within 7 to 10 days or gets worse
• Have any symptom that concerns you or does not go away