A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Restoril Warnings, Precautions, Pregnancy, Nursing, Abuse - Temazepam
Restoril Warnings, Precautions, Pregnancy, Nursing, Abuse - Temazepam
WARNINGS
Sleep disturbance
may be the presenting manifestation
of an underlying physical and/or psychiatric
disorder. Consequently, a decision to initiate symptomatic treatment
of insomnia should
only be made after the patient has been carefully evaluated.
The failure of insomnia
to remit after 7-10 days of treatment
may indicate the presence of a primary psychiatric
and/or medical illness.
Worsening of insomnia
may be the consequence
of an unrecognized psychiatric or physical
disorder as may be
the emergence of new abnormalities of thinking or behavior. Such
abnormalities have also been reported to occur in association with
the central nervous
system depressant
activity, including those of the benzodiazepine
class. Some of these changes may be characterized by decreased inhibition,
e.g., aggressiveness and extroversion
that seem out of character, similar to that seen with alcohol. Other
kinds of behavioral changes can also occur, for example, bizarre
behavior, agitation, hallucinations, depersonalization, and, in
primarily depressed
patients, the worsening of depression, including suicidal thinking.
In controlled clinical
trials involving 1076 patients on temazepam and 783 patients on
placebo, reports of hallucinations, agitation, and overstimulation
occurred at rates less than 1 in 100 patients. Hallucinations were
reported in 2 temazepam patients and 1 temazepam patient; 2 temazepam
patients reported overstimulation. 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 determined with certainty whether a particular instance
of the abnormal behavior
listed above is 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.
Because some of the worrisome adverse effects of benzodiazepines,
including temazepam, appear to be dose
related (see PRECAUTIONS
and DOSAGE
AND ADMINISTRATION), it is important to use the lowest possible
effective dose. Elderly patients are especially at risk.
Patients receiving temazepam should be cautioned about possible
combined effects with alcohol
and other CNS depressants.
Withdrawal symptoms of the barbiturate type) have occurred after
the abrupt discontinuation of benzodiazepines (see DRUG
ABUSE AND DEPENDENCE).
PRECAUTIONS
General
Since the risk of the
development of over-sedation,
dizziness, confusion, and/or ataxia
increases substantially with larger doses of benzodiazepines in
elderly and debilitated patients, 7.5 mg
of temazepam is recommended as the initial
dosage for such patients.
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. (See CONTRAINDICATIONS)
Information for the Patient
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.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Carcinogenicity studies were conducted in rats at dietary diazepam
doses up to 160 mg/kg/day for 24 months and in mice at dietary dose
of 160 mg/kg/day for 18 months. No evidence
of carcinogenicity was observed although hyperplastic liver nodules
were observed in female
mice exposed in female
mice exposed to the highest dose. The clinical
significance of this finding is not known.
Fertility in male and
female rats was not adversely
affected by temazepam.
No mutagenicity tests have been done with temazepam.
Pregnancy Category X
(See CONTRAINDICATIONS.)
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when temazepam is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness
in children below the age
of 18 years have not been established.
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