Restoril

Prescription required

Restoril

Available Form:  

CAPSULE

Manufacturer name:  

Aa Pharma

Generic name:  

TEMAZEPAM

Strength:  

15MG, 30MG

What is Restoril?

Restoril (Temazepam) belongs to the class of medications called benzodiazepines. It is used for the treatment of short-term sleeping problems (7 to 10 days) associated with difficulty falling asleep, frequent awakenings during the night, or early morning awakenings.

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Restoril How to Take

Restoril (Temazepam) belongs to the class of medications called benzodiazepines. It is used for the treatment of short-term sleeping problems (7 to 10 days) associated with difficulty falling asleep, frequent awakenings during the night, or early morning awakenings.

Restoril (Temazepam) may be available under multiple brand names and/or in several different forms. Any specific brand name of Restoril (Temazepam) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Restoril (Temazepam) may not be used for all of the conditions discussed here.

Your doctor may have suggested Restoril (Temazepam) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Restoril (Temazepam), speak to your doctor. Do not stop taking Restoril (Temazepam) without consulting your doctor.

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Restoril Dosage

The recommended adult dose of Restoril (Temazepam) ranges from 15 mg to 30 mg taken before going to bed. The lowest effective dose of medication should be used and treatment should normally not last longer than 7 to 10 consecutive days.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Restoril (Temazepam) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is the next morning, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Restoril (Temazepam) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Restoril Side Effects

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Restoril (Temazepam). If you are concerned about side effects, discuss the risks and benefits of Restoril (Temazepam) with your doctor.

The following side effects have been reported by at least 1% of people taking Restoril (Temazepam). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • clumsiness or unsteadiness
  • dizziness
  • drowsiness
  • lightheadedness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • agitation
  • anxiety
  • behavioural changes, including:
    • aggressiveness
    • angry outbursts
    • irritability
  • confusion
  • excitement
  • hallucinations
  • hyperactivity
  • lack of memory (of events taking place after the medication was taken)
  • signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • sleepwalking

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • thoughts of death or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Restoril (Temazepam).

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Your privacy is important. That's why we send your medication inside a plain delivery box so no one will know what's inside.

Restoril Available Form

15 mg
Each maroon and flesh-coloured, size 3 hard shell gelatin capsule, printed "TM15" in white, contains 15 mg of Restoril (Temazepam). Nonmedicinal ingredients: croscarmellose sodium,  D&C Red No. 28,  FD&C Blue No. 1, FD & C Red No. 40, gelatin, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, red iron oxide, shellac glaze, talc, simethicone, sodium lauryl sulfate, and titanium dioxide.

30 mg
Each maroon and blue-coloured, size 3 hard shell gelatin capsule, printed "TM30" in white, contains 30 mg of Restoril (Temazepam). Nonmedicinal ingredients: croscarmellose sodium,  D&C Red No. 28, FD&C Blue No. 1, FD & C Red No. 40, gelatin, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, talc, simethicone, sodium lauryl sulfate, and titanium dioxide.

Restoril Contraindications

Do not take Restoril (Temazepam) if you:

  • are allergic to Restoril (Temazepam) or any ingredients of Restoril (Temazepam)
  • are allergic to other benzodiazepines (e.g., Diazepam, Lorazepam)
  • have a history of paradoxical reactions (unusual excitement) to alcohol or sedatives
  • have Myasthenia Gravis
  • have Sleep Apnea
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Restoril Precautions

There may be an interaction between Restoril (Temazepam) and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Restoril (Temazepam). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Restoril Warnings

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Restoril (Temazepam).

HEALTH CANADA ADVISORY

October 30, 2020

Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Addiction potential: Restoril (Temazepam) can become habit-forming. Withdrawal symptoms similar to those occurring with other benzodiazepines and alcohol, have been observed after stopping the medication suddenly after having taken it regularly over as little as 2 to 3 weeks. These symptoms of withdrawal include:

  • abdominal cramps
  • agitation
  • confusion
  • Diarrhea
  • extreme anxiety
  • headache
  • irritability
  • memory impairment
  • muscle pain
  • nervousness
  • restlessness
  • sleep problems
  • tension
  • tremors
  • vomiting

If you have been taking Restoril (Temazepam) for a while, it should be stopped gradually as directed by your doctor.

Anxiety or restlessness: An increase in daytime anxiety or restlessness has been observed during treatment with Restoril (Temazepam).

Complex sleep-related behaviours: Occasionally, people taking Restoril (Temazepam) have experienced instances of driving, preparing food and eating, making phone calls and other activities while "sleeping". These events are generally not remembered. Taking Restoril (Temazepam) along with other medications that cause drowsiness, including alcohol, appears to increase the risk for these behaviours. If you observe these behaviours in a family member who is taking Restoril (Temazepam), or become aware of them yourself, contact your doctor as soon as possible.

Confusion: Restoril (Temazepam) may affect mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain injury.

Depression or psychosis: Abnormal thinking and psychotic behavioral changes have been reported with benzodiazepines (e.g., aggressiveness). Particular caution is warranted in patients with a history of violent behaviour.

If you have a history of depression or other mental illness, this may be more likely to occur. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Restoril (Temazepam), contact your doctor as soon as possible. You should be closely monitored by your doctor for emotional and behaviour changes while taking Restoril (Temazepam).

Drowsiness/reduced alertness: You should not engage in hazardous activities requiring complete mental alertness such as driving or operating machinery until the effects of Restoril (Temazepam) have worn off. Using alcohol or other drugs that cause drowsiness or sedation is not recommended.

Kidney function: Kidney Disease or reduced kidney function may cause Restoril (Temazepam) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Restoril (Temazepam) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Restoril (Temazepam), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Restoril (Temazepam) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Restoril (Temazepam) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Restoril (Temazepam), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Restoril (Temazepam).

Memory disturbance: Amnesia of varying severity has been reported following normal doses Restoril (Temazepam). Seniors are at particular risk.

Pregnancy: Restoril (Temazepam) may cause harm to a developing baby and should not be used during pregnancy. If you become pregnant while taking Restoril (Temazepam), contact your doctor immediately.

Breast-feeding: It is not known if Restoril (Temazepam) passes into breast milk. If you are a breast-feeding mother and are taking Restoril (Temazepam), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Restoril (Temazepam) have not been established for children below the age of 18 years.

Seniors: The sedative effects of Restoril (Temazepam) may affect seniors more than others. Extra caution is needed, for example, when getting up during the night.

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References

All material © 1996-2021 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition.

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