Temazepam
Risk Factor: XM
Class: CENTRAL NERVOUS SYSTEM DRUGS
/ Sedatives and Hypnotics
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
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 1020 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
- Product information. Restoril. Sandoz Pharmaceuticals Corp., 1993.
- 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.
- 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;33:2046.
-
Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
Questions and Answers
Does any one know if it's ok to take temazepam the restless leg syndrome medicine ok when your pregnant?? I'm 16 weeks pregnant and i cant sleep and my husband suggested this pill. So i was wondering if any knows if its ok.
You should call your doctor...They will have the answer better then anyone on here....You usually can call your doctor at any hours of the night...So call right now....I called my doc at like 1 am to ask if I could take air borne while pregnant.....
I am freaking out... please help.. I took Temazepam, im 37 wks pregnant? So I went to the doctor for my weekly check up and told him that I am having major problems sleeping. I have me a rx for Temazepam. Without thinking twice, hes the dr., i took one to help me sleep.
When I got up I was bored so I searched it on the web. This is what I found for the drug:
Pregnancy
Certain benzodiazepines have been linked to birth defects when taken by a pregnant woman in the early months of pregnancy. These medicines can also cause sedation of the unborn baby when used during the last weeks of pregnancy.
Restoril® (temazepam) should not be taken at any time during pregnancy. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Restoril® (temazepam).
OMG! Has anyone every taken this med while pregnant. I have only taken one 15mg capsule. I am so scared and so freaking out. The baby is moving around right now which puts me a little more at ease, but I am really stressing.
Well you are past the early part, and in the late part it is a worry because decresed fetal movement it s sign of trouble and if you are keeping them that way how will you know.
All medications have the if you are pregnant warning anymore. Each situation is different. I wouldn't worry hun. You baby is moving then baby is fine. I think they warn more for people who abuse things like that. You doctor wouldn't give it to you if you were a risk.
The worst it can do for you is make baby sleepy. And that is only a it can make the baby thing. There is no for sure. and your dose is very low.
Every drug has some stupid warning or another dosn't mean it is true they have to put it there.
They have a study out now showing freezing water in certain plastics can cause higher risk of cancer..I mean seriously, the risk factors could be .001 and they have to put a warning out.
34.5 weeks pregnant, doctor prescribed temazepam is it safe? Im having trouble believing taking a sleeping pill is 100% safe as quoted by my doc. She told me it wouldnt effect my bubs at all..? I briefly explained to her i have trouble sleeping..im gettin an average of 7 hrs sleep which is not enough for me. I told her Im beginning to get irratable and moody which may be linked its hard to say because im pregnant and uncomfortable anyway. I asked if there was anything I could do to help me sleep and she prescribed temaze but told me not to take them evry night due to the addictive nature. Is it really safe to take while Im pregnant? will my baby be put to sleep?
Your doc chose Temazepam because it's short-acting and mild. It should wear off about 2 hours after it's put you to sleep.
This is the guidance that's given to doctors and pharmacists regarding Temazepam and pregnancy:
Avoid regular use (risk of neonatal withdrawal symptoms); use only if clear indication such as seizure control (high doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression)
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.
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.
