TEMAZEPAM

Drugs in Pregnancy and Lactation.

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Name: TEMAZEPAM
Class: Hypnotic
Risk Factor:    XM

Fetal Risk Summary

Temazepam is a benzodiazepine that is used as a hypnotic for the short-term management of insomnia. Reproductive studies in rats revealed increased resorptions and an increased incidence of rudimentary ribs, which were considered skeletal variants (1). Exencephaly and fusion or asymmetry of ribs were observed in rabbits (1).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 146 newborns had been exposed to temazepam during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of six (4.1%) major birth defects were observed (six expected), including one cardiovascular defect (one expected) and two oral clefts (none expected). No anomalies were observed in four other categories of defects (spina bifida, polydactyly, limb-reduction defects, and hypospadias) for which specific data were available. Although the two oral clefts suggest a relationship with the drug, other factors, such as the mother's disease, concurrent drug use, and chance, may be involved.

A potential drug interaction between temazepam and diphenhydramine, resulting in the stillbirth of a term female infant, has been reported (2). The mother had taken diphenhydramine 50 mg for mild itching of the skin and approximately 1.5 hours later took 30 mg of temazepam for sleep. Three hours later she awoke with violent intrauterine fetal movements, which lasted several minutes and then abruptly stopped. The stillborn infant was delivered approximately 4 hours later. Autopsy revealed no gross or microscopic anomalies. In an experiment with pregnant rabbits, neither of the drugs alone caused fetal mortality but when combined, 51 (81%) of 63 fetuses were stillborn or died shortly after birth (2). No definite mechanism could be established for the apparent interaction.

Breast Feeding Summary

Temazepam is excreted in human breast milk. Ten mothers, within 15 days of delivery, were administered 10–20 mg of temazepam for at least 2 days as a bedtime hypnotic (3). Milk and plasma samples were obtained about 15 hours later corresponding to an infant feeding. Temazepam was detected (limit of detection 5 ng/mL) in the milk of only one woman with before- and after-feed levels of 28 and 26 ng/mL, respectively. The milk:plasma ratio in this patient was 0.12. Although no adverse effects were observed in the nursling, nursing infants of mothers consuming temazepam should be closely observed for sedation and poor feeding. The American Academy of Pediatrics considers the effects of temazepam on the nursing infant to be unknown, but they may be of concern (4).

References

  1. Product information. Restoril. Sandoz Pharmaceuticals Corp., 1993.
  2. Kargas GA, Kargas SA, Bruyere HJ Jr, Gilbert EF, Opitz JM. Perinatal mortality due to interaction of diphenhydramine and temazepam. N Engl J Med 1985;313:1417.
  3. Lepedevs TH, Wojnar-Horton RE, Yapp P, Roberts MJ, Dusci LJ, Hackett LP, Ilett KF. Excretion of temazepam in breast milk. Br J Clin Pharmacol 1992;33:204–6.
  4. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.

Index

Q&A about Temazepam

Purple.S...
Temazepam..?
What will happen if you were to mix temazepam and cocain?
Shannon V
you could wind up dead!!! cocaine being a stimulate is already

reeking havoc on your heart not to mention other organs in your body and then mixing it with a sleeping pill....its a very dangerous

and stupid thing to do. you need to get help and quick
John A
Does Temazepam work like Valium to sedate dogs?
The Vet has given my dog Valium in the past. I refuse to give her Acepromine (Thorazine).

Has there been any use of Temazepam on dogs for sedation?

Acepromine (Thorazine) is know to make a dog quiet and also make the dog feel terrible, plus it has been know to kill dogs, especially Boxers.
super_go...
xanax is a better choice, and is available through your vet. restoril (temazepam) is not commonly used in veterinary medicine and i would be scared to take a chance.
diamonds...
Has anyone taken Temazepam and had any side effects?
I took Temazepam a few days ago and felt really confused for days.

I also find taking it quite scary as literally 5 to 10 minutes after i take it i cant stand up or walk properly?

Has anyone taken it and had similar side effects or other side effects?
Michelle C
I've felt that way with other sleeping pills that I wouldn't take again, but I've never had a problem with temazepam. Did you exceed the dose or had you been drinking, not eating enough or something like that? I think people just react to different things so maybe its not right for you..
curiousm...
What is a lethal dose of Temazepam, is it more effective taking it with Diazepam?
This is not a suicide question, so please no christians advising not to do it or no stupid answers, just factual please. This is a research question. So once again, if you have nothing factual to answer don't bother. Thanks in advance.
MATRIX
Manifestations of acute overdosage of Temazepam can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. The oral LD50 of Temazepam was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits.

Interactions between your selected drugs

Diazepam and Temazepam (Moderate Drug-Drug)

MONITOR: Central nervous system- and/or respiratory-depressant effects may be additively or synergistically increased in patients taking multiple drugs that cause these effects, especially in elderly or debilitated patients.

MANAGEMENT: During concomitant use of these drugs, patients should be monitored for potentially excessive or prolonged CNS and respiratory depression. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities

Good Luck !
Media Control
What side effects did you get taking temazepam 30 mg for sleep?
stopped ambian and take this yellow capsule for sleep. ambian made me see spots and other things. this stuff makes me kinda druggy the next day. cannot sleep without help. went five days without sleep one time.
Simon G
temazepam or restoril is a has a very long half life so it will make you drowsy the next day. Romezecon is also an alternative. The question should be what is causing your insomnia.

Sincerely,

Doc
kri182
Can Temazepam cause fatality to a 13 year old?
I just asked a question saying could i give Temazepam to a 13 year old and i got an answer saying no becuase it could cause fatality (diaster leading to death)

Is this true?

Or was the person being silly?

Thanks
Ruth
Well, it would depend on the dosage ( 15 mg vs. 30 mg. ) and, how much is given. In addition, the body weight of this 13 year old can be a factor.

Temazepam ( Restoril) is a sleeping pill that is in the Benzo group of medications ( tranquilizers = Xanax, Valium, Klonopin ).

It is recommended to NOT give a person any medication that has not been prescribed for them directly. What if an allergic reaction occurred ?? Especially, an anaphylactic ( severe, life-threatening) reaction. Yes, this reaction can lead to death.

I hope that this answer has helped to clarify your concerns.
lillytat...
Can the drug temazepam affect your periods?
I have been on temazepam for nearly two months. My period is about 4 weeks late. My periods are not dead regular but normally I am only about 2 weeks late. I did a pregnancy test 2 weeks ago and it was negative. I don't think I am pregnant as I have been off the contraception pill since October 2004 and never got caught.
Beautifu...
I DON'T THINK IT DOES...I CHECKED IT OUT AND IT SAYS NOTHING ABOUT IT. BUT IF YOU THINK YOU ARE PREGNANT GO TO THE DOCTOR AND GET A BLOOD TEST DONE. A BLOOD TEST WILL SHOW YOU ARE PREGNANT 6 DAYS AFTER YOU CONCEIVE. MAYBE IT IS JUST STRESS.

What are temazepam tablets or capsules? (Back to top)

TEMAZEPAM (Restoril®) is a benzodiazepine. Benzodiazepines belong to a group of medicines that slow down the central nervous system. Temazepam helps to treat insomnia (difficulty sleeping at night). Federal law prohibits the transfer of temazepam to any person other than the patient for whom it was prescribed. Do not share this medicine with anyone else. Generic temazepam tablets and capsules are available.

What should my health care professional know before I take temazepam? (Back to top)

They need to know if you have any of these conditions:

•an alcohol or drug abuse problem

•bipolar disorder, depression, psychosis or other mental health condition

•glaucoma

•kidney disease

•liver disease

•lung disease, such as chronic obstructive pulmonary disease (COPD), sleep apnea or other breathing difficulties

•myasthenia gravis

•Parkinson's disease

•porphyria

•seizures or a history of seizures

•shortness of breath

•snoring

•suicidal thoughts

•uncontrolled pain

•an unusual or allergic reaction to temazepam, other benzodiazepines, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I take this medicine? (Back to top)

Take temazepam tablets or capsules by mouth. Temazepam is only for use at bedtime. Follow the directions on the prescription label. Swallow the tablets or capsules with a drink of water. If temazepam upsets your stomach, take it with food or milk. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose? (Back to top)

If you miss a dose, take it as soon as you can. It can take up to 2 hours for drowsiness to occur; never repeat the dose before 2 hours have passed. Do not take double or extra doses.

What drug(s) may interact with temazepam? (Back to top)

•alcohol

•barbiturate medicines for inducing sleep or treating seizures (convulsions), like phenobarbital

•caffeine

•female hormones, including contraceptive or birth control pills

•herbal or dietary supplements such as kava kava, melatonin, or valerian

•medicines for anxiety or sleeping problems, such as alprazolam, diazepam, lorazepam or triazolam

•medicines for depression, mental problems or psychiatric disturbances

•phenytoin

•prescription pain medicines

•probenecid

•some medicines for colds, hay fever or other allergies

•theophylline

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking temazepam? (Back to top)

Side effects that you should report to your prescriber or health care professional as soon as possible:

•confusion

•depression

•lightheadedness or fainting spells

•mood changes, excitability or aggressive behavior

•movement difficulty, staggering or jerky movements

•muscle cramps

•tremors

•weakness or tiredness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

•dizziness, drowsiness, clumsiness, or unsteadiness; a 'hangover' effect

•headache

•increased dreaming

•nausea, vomiting

What should I watch for while taking temazepam? (Back to top)

Visit your prescriber or health care professional for regular checks on your progress. Temazepam is for short-term periods of use. If sleep medicine is taken every night for a long time it may no longer help you to sleep. Your body can become dependent on temazepam, ask your prescriber or health care professional if you still need to take it. However, if you have been taking temazepam regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your prescriber or health care professional for advice. Even after you stop taking temazepam it can still affect your body for several days.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how temazepam affects you. To reduce the risk of dizzy and fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your prescriber or health care professional for advice. Some ingredients can increase possible side effects.

If you are going to have surgery, tell your prescriber or health care professional that you are taking temazepam.
kri182
Is it okay to give my 13 year old Temazepam?
My daughter is finding it hard to sleep she is just a little stressed and i have some Temazepam in the cupoard and im just wondering if i could give it to her this once?

Please dont reply saying if she hasnt been prescribed it then she should have it i want to know if it would be harmful to her?

Thanks

-mom
leigh j
brew her some chamomile tea minus the milk or put a little in and she should drop right off and wake up fresh in the morning.
"weee......
What drugs can you not mix with a sleeping pill such as temazepam?
I dont take depressants or anything. I avoid taking my sleeping pill because I know that you can become dependent on it, and I don't like taking drugs. However, I cannot afford to lose sleep. What everyday drugs (such as tylenol) do you need to avoid?

The thought of sleeping pills scares me very much!!
donavett...
Have you talked to your doctor about how it scares you? There are other, gentler sleeping medications like Lunesta or Rozerum that are less likely to cause dependency. If your doctor knows that you are worried about that, they should look at other options.
Karen L
How long does the sleeping med Temazepam stay in your urine or blood?
Cassandr...
Toxicology journals state that blood testing for this drug is rarely useful, so I would not be concerned about that. As for a urine test, the half-life of 9.5 to 13 hours should mean that the drug would be completely eliminated by about 30 to 50 hours. But remember that a urine test has to have a certain amount of drug to test positive and I doubt after 24 hours enough drug would be present, but this is a sheer quess. I do not know the actual sensitivity of these type of test.

Good Luck!!!