Brand name: Restoril
Temazepam is an active benzodiazepine with hypnotic properties. In sleep
laboratory studies, temazepam decreased the number of
nightly awakenings but had no effect on sleep latency. Rebound insomnia was
not observed after withdrawal of the drug. Temazepam
decreased stage 3, and combined stage 3 and 4 sleep, accompanied by a
compensatory increase in stage 2 sleep, but did not alter REM
Orally administered temazepam is well absorbed in man. Temazepam has a
half-life of about 8 to 10 hours in plasma (with
considerable inter-individual variability). On multiple dosing, steady
state is reached usually within 3 to 5 days with excretion of the
drug mainly in the urine in the form of the inactive O-conjugate metabolite.
Temazepam is a hypnotic agent useful in the short-term management of
insomnia. It has no effect, however, in shortening the time
taken by patients to fall asleep.
Efficacy has not been established in children under 18 years of age. As
with other hypnotics, temazepam is not indicated for prolonged
Hypersensitivity to benzodiazepines and in myasthenia gravis.
Since temazepam has a hypnotic effect, patients should be warned against
driving, operating dangerous machinery or engaging in
other activities requiring mental alertness and physical coordination after
taking the drug.
Physical and psychological dependence:
As with other benzodiazepines, temazepam should not be administered to
individuals prone to drug abuse. Caution should be observed
in all patients whose histories suggest that they may have potential for
psychological dependence. Withdrawal symptoms which tend to
occur after prolonged use of benzodiazepines are similar to those
manifested by patients with excessive anxiety and may appear to
justify continuation of drug use.
Potentiation of drug effects:
Temazepam may potentiate the effects of other CNS depressant drugs such as
alcohol, barbiturates, nonbarbiturate hypnotics,
antihistamines, narcotics, antipsychotic and antidepressant drugs, and
anticonvulsants. Therefore, different benzodiazepines should
usually not be used simultaneously and careful consideration should be
given if other CNS depressants are administered in
combination with temazepam. Patients should be advised against the
simultaneous use of other CNS depressant drugs and should be
cautioned not to take alcohol because of the potentiation of effects that
Safety in pregnancy has not been established and therefore, temazepam
should not be used during pregnancy. Several studies have
suggested an increased risk of congenital malformations associated with the
use of the benzodiazepines, chlordiazepoxide and
diazepam, and meprobamate, during the first trimester of pregnancy. Since
temazepam is also a benzodiazepine derivative, its
administration is rarely justified in women of child bearing potential. If
the drug is prescribed to a woman of child bearing potential,
she should be warned to consult her physician regarding discontinuation of
the drug if she intends to become or suspects that she is
Temazepam, having similar properties to other benzodiazepines, is probably
excreted in human milk and should not be given to
Patients with emotional disorders:
Temazepam should be used with caution in patients with symptoms of
depression or evidence of latent depression, particularly when
suicidal tendencies may be present and protective measures may be necessary.
Geriatrics and debilitated patients:
Elderly and debilitated patients, or those with organic brain syndrome, are
prone to CNS depression after even low doses of
benzodiazepines and may experience paradoxical reactions to these drugs.
Therefore, temazepam should be used in these patients only
in the lowest possible dose and adjusted when necessary under careful
observation, depending on the response of the patient.
Temazepam is metabolized in the liver and is primarily excreted by the
kidney. Hence, caution should be exercised in administration of
the drug to patients who might have impaired hepatic and/or renal function.
The most common adverse reactions reported after administration of
temazepam and other drugs of this class are dizziness, lethargy
and drowsiness. Confusion, euphoria, staggering, ataxia and falling are
commonly encountered. Paradoxical reactions such as
excitement, stimulation and hyperactivity and hallucinations are observed
Other adverse reactions are weakness, anorexia, horizontal nystagmus,
vertigo, tremor, lack of concentration, loss of equilibrium, dry
mouth, blurred vision, palpitations, faintness, hypotension, depression,
shortness of breath, nausea, diarrhea, abdominal discomfort,
genitourinary complaints, pruritus, skin rash, urticaria, and anterograde
amnesia. Abnormal liver function tests have been reported
occasionally with temazepam.
Manifestations of acute overdosage of temazepam, as with other
benzodiazepines, can be expected to reflect the increasing CNS effects
of the drug and include somnolence, confusion and coma, with reduced or
absent reflexes. With large overdoses, respiratory
depression, hypotension and finally coma will result.
If the patient is conscious, vomiting should be induced mechanically or
with emetics (e.g., syrup of ipecac 20 to 30 mL). Gastric
lavage should be employed as soon as possible, utilizing concurrently a
cuffed endotracheal tube if the patient is unconscious, in order
to prevent aspiration and pulmonary complications. Maintenance of adequate
pulmonary ventilation is essential and fluids should be
administered i.v. to encourage diuresis. The use of pressor agents i.v.,
may be necessary to combat hypotension but only if
considered essential. The value of dialysis in emergency therapy for
benzodiazepine overdosage has not been determined. If excitation
occurs, barbiturates should not be used. It should be borne in mind that
multiple agents may have been ingested.
An appropriate hypnotic dose should produce the desired hypnotic effect
while avoiding oversedation and impairment of performance
the next day.
30 mg before retiring.
In elderly and debilitated patients:
The initial dose should not exceed 15 mg before retiring (see Precautions).
Temazepam is not indicated in children below 18 years of age.
Temazepam is intended only for short-term use and, therefore, should not be
prescribed in quantities exceeding those required for that
cycle of administration. Prescriptions should not be renewed without
further assessment of the patient's needs.
Each maroon and blue capsule, imprinted "Restoril 30" and "SANDOZ"
contains: Temazepam 30 mg. Also contains lactose. Bottles of
Each maroon and flesh colored capsule, imprinted "Restoril 15" and "SANDOZ"
contains: Temazepam 15 mg. Also contains lactose.
Bottles of 100.
Protect from moisture and excessive heat.
Time exists so everything doesn't happen at once,
Space exists so everything doesn't happen to you.
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