Restoril

Restoril is a prescription medication used to treat insomnia. Restoril belongs to a group of drugs called benzodiazepines. It works by slowing activity in the brain to allow sleep.

This medication comes in capsule form. It is usually taken as needed at bedtime.

Common side effects of Restoril are drowsiness, headache, and tiredness.

Restoril is a prescription medication used in the treatment of a sleep problem called insomnia. Symptoms of insomnia include:

• trouble falling asleep
• waking up often during the night

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Mallinckrodt, Inc.

The most common side effects of Restoril are:

• drowsiness
• headache
• tiredness
• nervousness
• dizziness
• nausea
• “hangover” feeling the day after taking Restoril
• You may still feel drowsy the next day after taking Restoril. Do not drive or do other dangerous activities after taking Restoril until you feel fully awake.
• You may have withdrawal symptoms if you stop taking Restoril suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your doctor to check if you need to stop Restoril slowly.

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antidepressants
• antihistamines
• medicines for anxiety, mental illness, seizures, or pain
• sedatives
• other sleeping pills
• tranquilizers

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Possible serious side effects of Restoril include:

• getting out of bed while not being fully awake and doing an activity that you do not know you are doing. After taking Restoril, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Restoril. Reported activities include:
  • driving a car (“sleep-driving”)
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking

  Call your doctor right away if you find out that you have done any of the above activities after taking Restoril.

• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Restoril.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Restoril.

Important:

1. TakeRestoril exactly as prescribed.
   • Do not take more Restoril than prescribed.
   • Take Restoril right before you get in bed, not sooner.
2. Do not take Restoril if you:
   • drink alcohol
   • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Restoril with your other medicines.
   • cannot get a full night's sleep.

Do not take Restoril if you are pregnant or planning to become pregnant. Restoril may cause birth defects or harm a fetus (unborn baby).

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Restoril there are no specific foods that you must exclude from your diet.

Before starting Restoril, tell your doctor about all of your health conditions, including if you:

• are allergic to any ingredients in Restoril
• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take Restoril with other medicines that can make you sleepy.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. It has been shown that women taking Restoril during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Restoril is excreted in human breast milk or if it will harm your nursing baby.

• Take Restoril exactly as prescribed. Do not take more Restoril than prescribed for you.
• Take Restoril right before you get into bed.
• Do not take Restoril unless you are able to get a full night's sleep before you must be active again.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.
• If you take too much Restoril or overdose, call your doctor or poison control center right away, or get emergency treatment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose range is 7.5 mg to 30 mg.

If you take too much Restoril or overdose, call your doctor or poison control center right away, or get emergency treatment.

• Store Restoril at room temperature, 68° to 77°F (20° to 25°C).
• Keep Restoril and all medicines out of reach of children.

Restoril is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Restoril in a safe place to prevent misuse and abuse. Selling or giving away Restoril may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.