Generic Name: temazepam (Oral route)
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Hypnotic
Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting
Uses For Restoril
Temazepam is used to treat insomnia (trouble with sleeping). This medicine is for short-term (usually 7 to 10 days) use only. Temazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.
This medicine is available only with your doctor's prescription.
Before Using Restoril
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of temazepam in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving temazepam.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Sodium Oxybate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- St John's Wort
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol or abuse, or history of or
- Breathing problems or lung disease or
- Depression, history of or
- Drug abuse or dependence, or history of or
- Mental health problems, history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of Restoril
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Take temazepam just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For insomnia (trouble sleeping):
- Adults—15 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.
- Older adults—At first, 7.5 mg at bedtime. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For insomnia (trouble sleeping):
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Use this medicine only when you cannot sleep. You do not need to take it on a schedule.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Restoril
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.
If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.
This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though temazepam is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to temazepam before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.
If you develop any unusual and strange thoughts or behavior while you are taking temazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of temazepam or taking alcohol or other CNS depressants with temazepam may lead to breathing problems and unconsciousness.
Temazepam may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, tongue, mouth, or throat while you are using this medicine.
Restoril Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
- False or unusual sense of well-being
- fear or nervousness
- mood or mental changes
- Difficult or labored breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- loss of appetite
- loss of memory
- problems with memory
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- tightness in the chest
- uncontrolled eye movements
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual excitement, nervousness, restlessness, or irritability
- weight loss
- Muscle cramps
- shakiness in the legs, arms, hands, or feet
- stomach cramps
- trembling or shaking of the hands or feet
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Blurred vision
- change in consciousness
- decreased or absent reflexes
- difficult or troubled breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular, fast, slow, or shallow breathing
- loss of consciousness
- pale or blue lips, fingernails, or skin
- sleepiness or unusual drowsiness
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- dry mouth
- feeling of constant movement of self or surroundings
- sensation of spinning
- unusual dullness or feeling of sluggishness
- burning eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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More about Restoril (temazepam)
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- Drug class: benzodiazepines