There were no reports of worsening of depression or suicidal ideation, aggressiveness, extroversion, bizarre behavior or depersonalization in these controlled clinical trials. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. Elderly patients are especially at risk.
Patients receiving temazepam should be cautioned about possible combined effects with alcohol and other CNS depressants. Temazepam should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary.
The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. If temazepam is to be combined with other drugs having known hypnotic properties or CNS depressant effects, consideration should be given to potential additive effects. The possibility of a synergistic effect exists with the co-administration of temazepam and diphenhydramine.
One case of stillbirth at term has been reported 8 hours after a pregnant patient received temazepam and diphenhydramine. A cause and effect relationship has not yet been determined. Information for Patients The text of a patient package insert is printed at the end of this insert. To assure safe and effective use of temazepam, the information and instructions provided in this patient package insert should be discussed with patients.
Laboratory Tests The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines. Drug Interactions The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.
An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies.
Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with Temazepam were performed in rats and rabbits.
In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls.
Temazepam is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior.
Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class. Elderly patients are especially at risk. Some of these changes may be characterized by decreased inhibition, e. Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization.
Although behaviors such as sleep-driving may occur with Temazepam alone at therapeutic doses, the use of alcohol and other CNS depressants with Temazepam appears to increase the risk of such behaviors, as does the use of Temazepam at doses exceeding the maximum recommended dose.
Other complex behaviors e. Your physician can rule out any medical conditions that may cause insomnia. Your pharmacist or physician can inform you if your are taking any medications that may have insomnia as a side effect. Is the dosage in two temazepam 15 mg capsules equivalent to one temazepam 30 mg capsule? Theoretically, these should be the same amount since the mg milligram refers to the amount of drug in each capsule.
Therefore, 15 mg multiplied by 2 is equal to 30 mg. Theoretically, there may be a slightly different effect in the body since the body needs to absorb two separate capsules versus one. Even if this would play a role in the effects of the medication, it would be very small. Please talk with your health care provider about your concerns regarding the dosing of temazepam Restoril. I've been taking temazepam for a year for insomnia. I'm worried that it's caused my recent acid reflux, and that I might be getting dependent on it.
Could either of those be true? While some medications irritate the stomach and produce effects of acid reflux, temazepam isn't one of them. Acid reflux is not a reported side effect of temazepam, according to the U. Food and Drug Administration, so it's unlikely that the temazepam is the reason for your reflux. Acid reflux is typically triggered by overeating or some other factor such as medication use that causes the stomach acid to overwhelm the valve that normally protects the esophagus from stomach acid.
Reported stomach-related side effects of temazepam are nausea and vomiting. As for your concerns about dependence, temazepam is designed for short-term use because if the medication is taken every night for a long period of time, it may no longer help patients sleep. Your body can become dependent on temazepam, which is why a regular conversation about the medication with your doctor is important.
Since you've been taking this medication regularly for some time now, don't stop taking it suddenly without your doctor's guidance and monitoring, as you may experience severe side effects. Recent studies show that there are other medications for insomnia that have less risk of dependence and fewer side effects, such as zolpidem Ambien , Rozerem, Sonata, or Lunesta.
You might want to discuss your worries about dependency, as well as these other medications, with your doctor. My father cannot swallow pills. Is it alright to open the temazepam capsule and put the medication in applesauce so he can swallow it? Even then, it will depend on how the capsule and the medication inside is formulated. It may harm an unborn baby. If you are a woman of childbearing age, use a reliable form of birth control while taking this drug. If you are planning pregnancy, do not take this medication.
If you become pregnant or think you may be pregnant, tell your doctor right away. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast -feeding. Interactions See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
A product that may interact with this drug is: Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers such as codeine, hydrocodone , alcohol, marijuana , other drugs for sleep or anxiety such as alprazolam , lorazepam , zolpidem , muscle relaxants such as carisoprodol , cyclobenzaprine , or antihistamines such as cetirizine , diphenhydramine. Check the labels on all your medicines such as allergy or cough -and-cold products because they may contain ingredients that cause drowsiness.
Ask your pharmacist about using those products safely. Should I avoid certain foods while taking Temazepam? Overdose If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Otherwise, call a poison control center right away.
US residents can call their local poison control center at Canada residents can call a provincial poison control center. Symptoms of overdose may include slowed breathing or a deep sleep from which you cannot be awakened. Notes Do not share this medication with others.
It is against the law. As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night.
This medication may make you sleepy during the day. Your dose may 15mg to be adjusted. One case of stillbirth at term has been reported 8 hours after a pregnant patient received Temazepam and diphenhydramine. Thus, temazepam capsules 15mg, formation of the major metabolite is the rate limiting step in the biodisposition of temazepam. No mutagenicity tests have been done with Temazepam. 15mg physician can rule out any medical conditions that may cause insomnia. Fluids should be temazepam intravenously to encourage diuresis, temazepam capsules 15mg. I believe you will find the following link at EverydayHealth, temazepam capsules 15mg. Other complex behaviors e. Patients should be instructed to discontinue the drug prior temazepam becoming pregnant. Talk to your doctor if you are using marijuana. Temazepam must not be used during pregnancy. Although these abnormalities capsule not found in the concurrent control group, they have been reported to occur randomly in historical controls. The possibility of a synergistic capsule exists with the co-administration of temazepam and diphenhydramine. Please talk with your temazepam about your concerns about the dosing of your temazepam Restoril. It acts on your brain to produce a calming effect. Many people 15mg this medication do not have oxycontin 25mg tablets capsule effects.
It may harm an unborn baby. Take this medication exactly as prescribed to lower the temazepam of addiction. If angioedema involves the tongue, temazepam capsules 15mg, glottis or larynx, airway obstruction may occur and be fatal. Amnesia and other neuro-psychiatric symptoms may occur unpredictably. Because many drugs are excreted in human milk, caution should be exercised when Restoril is administered to a nursing woman. This month when I filled it, I feel dizzy in bed and don't feel right at night. Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and temazepam complications. No evidence of carcinogenicity was observed 15mg hyperplastic liver nodules were observed in female mice exposed to the highest dose. Tell your doctor right away if you have any serious side effects, including: Pediatric Use Safety and effectiveness 15mg pediatric patients have not been established. In rabbits, occasional abnormalities such as exencephaly and capsule or asymmetry of ribs were reported without dose relationship. If you would like to obtain more information about these advertising practices and to make choices about online behavioral capsule, please click here. There is no accumulation of metabolites.
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