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Generic Name: temazepam (te MAZ e pam)
Brand Names: Restoril
Temazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Temazepam affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).
Temazepam is used to treat insomnia symptoms, such as trouble falling asleep or staying asleep.
Do not use temazepam if you are pregnant. This medicine can cause birth defects or life-threatening withdrawal symptoms in a newborn.
Temazepam may be habit-forming and should be used only by the person it was prescribed for. This medicine 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.Misuse of habit-forming medicine can cause addiction, overdose, or death.
Temazepam may cause a severe allergic reaction. Stop taking this medicine 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. Take this medication only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.
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 temazepam and talk with your doctor about another treatment for your sleep disorder.
You should not use this medicine if you are allergic to temazepam or to other benzodiazepines (alprazolam, Xanax, Valium, or others).
To make sure temazepam is safe for you, tell your doctor if you have:
asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
kidney or liver disease;
a history of depression or suicidal thoughts or behavior;
a history of drug or alcohol addiction; or
if you use a narcotic (opioid) medication.
Do not use temazepam if you are pregnant or may become pregnant. This medicine can cause birth defects. Your baby could also become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are taking temazepam.
Temazepam can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
The sedative effects of temazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking this medicine.
Temazepam is not approved for use by anyone younger than 18 years old.
Take temazepam exactly as it was prescribed for you. Follow all directions on your prescription label. Never use in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in treating your symptoms.
Temazepam may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
You should not even share this medicine with another person who has the same symptoms you have.
Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.
Take temazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.
Do not take this medicine unless you are able to get a full night's sleep before you must be active again.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using temazepam.
Temazepam should be used for only a short time to treat insomnia. Call your doctor if your symptoms do not improve after 7 to 10 nights of treatment, or if this medicine seems to stop working as well in helping you fall asleep and stay asleep.
Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Your insomnia symptoms may also return when you stop using the medicine. Ask your doctor how to safely stop taking temazepam.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Temazepam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Since this medicine is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medicine if you do not have at least 7 to 8 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of temazepam can be fatal, especially if taken with alcohol. Overdose symptoms may include extreme drowsiness, confusion, or loss of consciousness and coma.
Do not drink alcohol while you are taking temazepam.
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.
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 this medicine and talk with your doctor about another treatment for your sleep disorder.
Call your doctor at once if you have:
confusion, agitation, hostility, hallucinations;
anxiety, memory problems;
depressed mood; or
thoughts of suicide or hurting yourself.
Common temazepam side effects may include:
day-time drowsiness or "hangover" feeling;
headache;
dizziness, tiredness;
nausea; or
feeling nervous.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Insomnia:
7.5 to 30 mg orally once a day at bedtime
Comments:
-In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency.
-In elderly or debilitated patients, therapy should be initiated at 7.5 mg until inpidual responses are determined.
Use: Short-term treatment of insomnia (generally 7 to 10 days)
Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with temazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use temazepam only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Temazepam (www.drugs.com/temazepam.html).
More frequently reported side effects include: dizziness, insomnia, lethargy, and irritability. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to temazepam: oral capsule
Oral route (Capsule)
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.
Along with its needed effects, temazepam 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 while taking temazepam:
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking temazepam:
Symptoms of overdose
Some side effects of temazepam 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
Rare
For Healthcare Professionals
Applies to temazepam: oral capsule
GeneralThe most commonly reported side effects included drowsiness, headache, and fatigue.
Nervous systemLightheadedness, slurred speech, and unsteadiness usually occur at the start of treatment and disappear with repeated doses.
Common (1% to 10%): Dizziness, drowsiness, hangover, headache, lethargy, sedation, vertigo
Uncommon (0.1% to 1%): Ataxia, equilibrium loss, faintness, muzziness, sciatica, taste loss, tremor
Rare (0.01% to 0.1%): Dysarthria
Frequency not reported: Amnesia, anterograde amnesia, coma, convulsions, daytime drowsiness, epileptic seizures, extrapyramidal symptoms, extremity tingling, horizontal nystagmus, hypersensitivity to light/noise/physical contact, impaired concentration, lightheadedness, numbness, oversedation, perceptual disturbances, reduced alertness, seizures, slurred speech, unsteadiness
PsychiatricCommon (1% to 10%): Anxiety, confusion, depression, euphoria, nervousness, nightmares
Uncommon (0.1% to 1%): Decreased orgasm, disorientation, increased dreaming, irritability, libido changes, unmasking of depression, vivid dreams
Rare (0.01% to 0.1%): Restless sleep
Frequency not reported: Abuse, aggressiveness/aggression, agitation, broken sleep (with vivid dreams), confusional states, delusion, depersonalization, dependence, derealization, disinhibition, excitement, extreme anxiety, hallucinations, hostility, inappropriate behavior, insomnia, mood changes, numbed emotions, other adverse behavioral effects, overstimulation, physical dependence, psychological dependence, psychoses, psychotic manifestations, rage, rebound insomnia, restlessness, sexual arousal, sleep disturbance, stimulation, suicidal attempt, suicidal ideation, tension, withdrawal effects/symptoms
Dependence and numbed emotions usually occur at the start of treatment and disappear with repeated doses.
GastrointestinalCommon (1% to 10%): Abdominal discomfort, diarrhea, dry mouth, nausea
Uncommon (0.1% to 1%): Gastrointestinal upset, vomiting
Rare (0.01% to 0.1%): Salivation changes
Frequency not reported: Abdominal cramps, constipation, gastrointestinal disturbances
OtherCommon (1% to 10%): Fatigue, weakness
Uncommon (0.1% to 1%): Asthenia
Frequency not reported: Falls, hyperacusis, hypothermia, paradoxical reactions, rebound phenomenon, tinnitus
OcularCommon (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Burning eyes
Rare (0.01% to 0.1%): Visual disturbances
Frequency not reported: Diplopia/double vision, photophobia
Double vision usually occurs at the start of treatment and disappears with repeated doses.
DermatologicUncommon (0.1% to 1%): Allergic skin reactions, hyperhidrosis, macular rash, pruritus
Rare (0.01% to 0.1%): Skin reactions
Frequency not reported: Alopecia, sweating
HematologicUncommon (0.1% to 1%): Increased neutrophils, leukocytosis
Rare (0.01% to 0.1%): Blood disorders, blood dyscrasias
Frequency not reported: Agranulocytosis, pancytopenia, thrombocytopenia
HepaticUncommon (0.1% to 1%): Increased AST, increased bilirubin
Rare (0.01% to 0.1%): Abnormal liver function, jaundice
Frequency not reported: Increased liver enzymes
GenitourinaryUncommon (0.1% to 1%): Impotence, proteinuria
Rare (0.01% to 0.1%): Incontinence, urinary retention
CardiovascularUncommon (0.1% to 1%): Palpitations, tachycardia
Rare (0.01% to 0.1%): Hypotension
Frequency not reported: Lowering in blood pressure, mild systolic hypertension, orthostatic hypotension
MusculoskeletalUncommon (0.1% to 1%): Backache, leg cramps
Rare (0.01% to 0.1%): Impaired muscular function
Frequency not reported: Muscle pain, muscle weakness
Muscle weakness usually occurs at the start of treatment and disappears with repeated doses.
RespiratoryRespiratory depression usually occurs at the start of treatment and disappears with repeated doses.
Uncommon (0.1% to 1%): Breathlessness, dyspnea
Frequency not reported: Apnea, respiratory depression, worsening of obstructive pulmonary disease, worsening of sleep apnea
MetabolicUncommon (0.1% to 1%): Anorexia, increased serum alkaline phosphatase
Frequency not reported: Hyponatremia, loss of appetite
RenalUncommon (0.1% to 1%): Increased blood urea nitrogen
HypersensitivityRare (0.01% to 0.1%): Fatal anaphylaxis
Frequency not reported: Hypersensitivity reactions, severe anaphylactic reaction, severe anaphylactoid reaction
EndocrineFrequency not reported: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Temazepam (www.drugs.com/temazepam.html).
March 11, 2021
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