Drug Index

GENERIC NAME :
temazepam

BRAND NAMES :
Restoril, Euhypnos, Normison, Remestan, Tenox and Norkotral (7.5 mg, 15 mg, 22.5 mg, and 30 mg capsules)

STREET NAMES :
downers, benzo's, tranq's

BRIEF DESCRIPTION :
Temazepam is categorized as a central nervous system sedative/hypnotic (tranquilizer). It belongs to a class of drugs known as benzodiazepines, which are the most widely prescribed medications that affect central nervous system function. The main pharmacological action of temazepam is to increase the effect of the neurotransmitter GABA (gamma-aminobutyric acid) at the GABA (A) receptor. This causes sedation, motor-impairment, ataxia (an inability to coordinate voluntary muscular movements), anxiolysis (reduction in anxiety), anticonvulsant (anti-seizure) effect, muscle relaxation and reinforcing effect. Temazepam was well absorbed and found to have minimal (8%) first pass (through the liver) drug metabolism. There were no active metabolites formed and the only significant metabolite present in blood was the O-conjugate. The unchanged drug was 96% bound to plasma proteins. The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4-0.6 hours and the terminal half-life from 3.5-18.4 hours (mean 8.8 hours). It is completely metabolized through conjugation prior to excretion; in studies, 80% of the dose appeared in the urine. The major metabolite was the O-conjugate of temazepam (90%); the O-conjugate of N-desmethyl temazepam was a minor metabolite (7%).

INDICATIONS FOR USE :
Temazepam is indicated for the short-term treatment of insomnia.

ABUSE AND ADDICTIVE POTENTIAL :
Temazepam is a short acting benzodiazepine and demonstrates potential for dependence. This is especially true in individuals with a history of drug addiction or alcoholism. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving temazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. In general, temazepam should be prescribed for short periods of time. Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Withdrawal can appear following cessation of recommended doses. Generally speaking, the longer the medication is used and/or the higher the dose the more withdrawal symptoms may occur. Abrupt discontinuation should be avoided if it has been used for several consecutive months. Although temazepam showed less tendency for tolerance than most other benzodiazepines, tolerance can occur in some individuals after taking the medication for several weeks or months. This means that dosages prescribed for treatment may need to be increased some over time to achieve the therapeutic response. It also means that individuals who have become addicted to temazepam will need to progressively increase the dosage to achieve the desired mood state that the addict is seeking. Addicted individuals often take more than the recommended dosage.

OVERDOSAGE :

Manifestations of overdoseage may include:

  • • somnolence (extreme drowsiness or deep, prolonged sleep)
  • • confusion
  • • slurred speech
  • • impaired coordination
  • • diminished reflexes
  • • coma
  • • hypotension (abnormally low blood pressure)

Emergency medical treatment is advised if overdose is suspected.



CAUTIONS :
Temazepam should not be used simultaneously with alcohol or any other central nervous system depressant drugs. Taken together, these drugs can potentiate the potency and effect of each drug. The possibility of a synergistic effect (amplified effect caused by taking both drugs together) exists with the co-administration of temazepam and diphenhydramine (Benadryl).As with other benzodiazepines, temazepam produces additive CNS depressant effects when co-administered with other medications which themselves produce CNS depression, such as barbiturates, alcohol, opiates, tricyclic antidepressants, non-selective MAO inhibitors, phenothiazines and other antipsychotics, skeletal muscle relaxants, antihistamines and anaesthetics. Administration of theophylline or aminophylline has been shown to reduce the sedative effects of temazepam and other benzodiazepines. Precaution should be observed in using this medication in patients who have impaired kidney or liver function. Also, in geriatric patients the half-life of elimination of the drug may be extended several hours, requiring careful monitoring and possibly a lower dosage range of prescribing medication. If temazepam is given concomitantly with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of all agents. Always check first with a physician or pharmacist before taking temazepam while taking any other prescription medications. Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs. Unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system (in the liver) have not been observed with temazepam. Withdrawal symptoms, similar in character to those noted with other benzodiazepines, barbiturates and alcohol (e.g., convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of temazepam. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Patients with a history of seizures, regardless of their concomitant anti-seizure drug therapy, should not be withdrawn abruptly from benzodiazepines. Consequently, after extended therapy (especially with dosages higher than 15 mg a day), abrupt discontinuation should generally be done under the supervision of a physician and often involves tapering the medication slowly and/or use of other medications to manage withdrawal symptoms. Temazepam is contraindicated in pregnancy. A child born of a mother who is taking benzodiazepines may be at some risk for withdrawal symptoms following birth. It is not known whether this drug is excreted in breast milk.

SIDE EFFECTS :
Common The typical side effects of typical of hypnotic benzodiazepines are related to CNS depression, and include somnolence (excessive sleepiness), dizziness, fatigue, ataxia, headache, lethargy (sluggishness), impairment of memory and learning, increased reaction time and impairment of motor functions (including coordination problems), slurred speech, decreased physical performance, numbed emotions, reduced alertness, muscle weakness, blurred vision (in higher doses), and inattention. Euphoria was rarely reported with the use of temazepam. According to the FDA, temazepam had an incidence of euphoria of 1.5%, much more rarely reported than headaches and diarrhea. Anterograde amnesia may also develop, as may respiratory depression in higher doses. Less common Hyperhidrosis (excessive sweating), hypotension, burning eyes, changes in libido (sex drive), hallucinations, faintness, horizontal nystagmus (abnormal eye movements), vomiting, pruritus (itching), gastrointestinal disturbances, nightmares, palpitation (irregular heart rhythm) and paradoxical reactions that are opposite those expected) including restlessness, aggression, violence, over stimulation and agitation have been reported, but are rare (less than 0.5%). Before taking temazepam, one should ensure that at least 8 hours are available to dedicate to sleep. Failing to do so can increase the side effects of the drug.

FOR MORE INFORMATION :
*This is a condensed description of this medication. For more details check with your physician, pharmacist, or resources such as The Physicians' Desk Reference (PDR) or http://www.drugs.com


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