Zopiclone belongs to the group of medicines called central nervous system (CNS) depressants (medicines that make you drowsy or less alert).

Indications and Usage

Zopiclone is a novel hypnotic agent used in the treatment of insomnia. Its mechanism of action is based on modulating benzodiazepine receptors. In addition to zopiclone's benzodiazepine pharmacological properties it also has some barbiturate-like properties. Zopiclone is used to treat insomnia (trouble in sleeping). Zopiclone helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

Take this medication by mouth as directed by your doctor, usually once nightly just before bedtime. Dosage is based on your medical condition, age, other medications you may be taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Follow your doctor's instructions carefully. Do not take more of this medication than prescribed because your risk of side effects will increase. Although unlikely, this drug may rarely cause temporary memory loss. To avoid this effect, do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. This amount of time is needed for your body to get over the effects of this drug. For example, do not take zopiclone to help you sleep during an overnight plane flight of less than 7 to 8 hours. If you suddenly stop using this medication, you may have withdrawal symptoms (such as stomach/muscle cramps, shaking, sweating, anxiety, vomiting, rare seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zopiclone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and it is normal. It will usually go away after 1 to 2 days. If this effect continues, contact your doctor.

What form(s) does this medication come in?

5 mg
Each round, white, biconvex, film-coated tablet, engraved "ZOP" over "5" on one side and "APO" on the other, contains 5 mg of zopiclone. Nonmedicinal ingredients: carnauba wax, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

7.5 mg
Each oval, blue, film-coated tablet, scored and engraved "APO 7.5" on one side, contains 7.5 mg of zopiclone. Nonmedicinal ingredients: brilliant blue FCF Aluminum Lake, carnauba wax, D&C Yellow No. 10 Aluminum Lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Dosage and Administration

Take this medication by mouth before bedtime as directed. This medication is usually taken for short periods of up to 4 weeks. Do not increase the dose or take this for longer than prescribed. Tolerance may develop with long-term or excessive use making it less effective. If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include excessive drowsiness; slow, shallow breathing; sudden onset of sweating; pale skin; blurred vision; and loss of consciousness. Take your dose at or near bedtime. If you miss a dose, do not take if near the time for the next dose. Instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. The usual starting dose is 3.75 mg taken just before bedtime when required to help with difficulty sleeping. The recommended adult dose of zopiclone ranges from 3.75 mg to 7.5 mg. The maximum daily dose is 5 mg for seniors, people with reduced liver or kidney function, and people taking certain medications. This medication may be habit-forming and should be taken exactly as prescribed by your doctor. You should not typically use zopiclone for more than 7 to 10 days in a row.

Who should NOT take this medication?

Do not take this medication if you:

Side Effects

Daytime drowsiness, dizziness, lightheadedness, bitter taste, dry mouth, headache or stomach upset may occur the first few days as your body adjusts to the medication. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: rapid/pounding/irregular heartbeat, skin rash, changes in vision, slurred speech, severe drowsiness, loss of memory, incoordination, confusion, depression, irritability or other behavioral changes. medication. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor if you have: kidney disease, liver disease, breathing problems, myasthenia gravis, a history of drug dependence, depression, seizures, allergies. Because this medication may cause drowsiness, use caution operating machinery or engaging in activities requiring alertness. Also limit alcoholic beverages which can aggravate these effects. This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. Since small amounts of this medication are found in breast milk, consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: sodium oxybate.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Zopiclone is very similar to eszopiclone. Do not use medications containing eszopiclone while using zopiclone.

Warning

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 (possibly fatal) to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. You should not take this medication or similar medications (such as eszopiclone, zolpidem) if you have this reaction to the medication.