Lunesta

DRUG DESCRIPTION

LUNESTA (Eszopiclone) is a non benzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro- 5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17CIN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:

LUNESTA*
(Eszopiclone) Structural Formula Illustration

Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).

Eszopiclone is formulated as film-coated tablets for oral administration. LUNESTA tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.

What are the possible side effects of eszopiclone (Lunesta)?

Eszopiclone may cause a severe allergic reaction. Stop taking eszopiclone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using eszopiclone and call your doctor at once if you have any of these serious side effects:

  • aggression, agitation, changes in behavior;
  • thoughts of hurting yourself; or
  • hallucinations (hearing or seeing things).

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Lunesta

What are the precautions when taking eszopiclone (Lunesta)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung diseases (e.g., chronic obstructive pulmonary disease, sleep apnea), mental/mood problems...

Read All Potential Precautions of Lunesta


Lunesta Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, headache, and unpleasant taste may occur. To minimize the risk of falls, remember to get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., worsening depression, hallucinations, agitation, or rare thoughts of suicide), memory problems, loss of coordination, signs of infection (e.g., fever, chills, persistent sore throat).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking eszopiclone.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung diseases (e.g., chronic obstructive pulmonary disease, sleep apnea), mental/mood problems (e.g., depression), personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially drowsiness and dry mouth.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who take this medication near the time of delivery may have undesirable effects such as excessive sleepiness. Tell your doctor if you notice such effects in your newborn.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.


Lunesta Patient Information Including Side Effects

Brand Names: Lunesta

Generic Name: eszopiclone (Pronunciation: e ZOP i klone)

  • What is eszopiclone (Lunesta)?
  • What are the possible side effects of eszopiclone (Lunesta)?
  • What is the most important information I should know about eszopiclone (Lunesta)?
  • What should I discuss with my healthcare provider before taking eszopiclone (Lunesta)?
  • How should I take eszopiclone (Lunesta)?
  • What happens if I miss a dose (Lunesta)?
  • What happens if I overdose (Lunesta)?
  • What should I avoid while taking eszopiclone (Lunesta)?
  • What other drugs will affect eszopiclone (Lunesta)?
  • Where can I get more information?

What is eszopiclone (Lunesta)?

Eszopiclone is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Eszopiclone is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.

Eszopiclone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of eszopiclone (Lunesta)?

Eszopiclone may cause a severe allergic reaction. Stop taking eszopiclone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using eszopiclone and call your doctor at once if you have any of these serious side effects:

  • aggression, agitation, changes in behavior;
  • thoughts of hurting yourself; or
  • hallucinations (hearing or seeing things).

Less serious side effects may include:

  • day-time drowsiness, dizziness, "hangover" feeling;
  • problems with memory or concentration;
  • anxiety, depression, nervous feeling;
  • headache;
  • nausea, stomach pain, loss of appetite, constipation;
  • dry mouth;
  • unusual or unpleasant taste in your mouth; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about eszopiclone (Lunesta)?

Eszopiclone may cause a severe allergic reaction. Stop taking eszopiclone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Eszopiclone will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 8 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking eszopiclone and talk with your doctor about another treatment for your sleep disorder.

Eszopiclone can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not drink alcohol while you are taking eszopiclone. It can increase some of the side effects of eszopiclone, including drowsiness.

Eszopiclone may be habit-forming and should be used only by the person it was prescribed for. Eszopiclone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking eszopiclone after taking it over several days in a row. Do not stop taking eszopiclone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

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