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 Side Effects, and Drug Interactions - Temazepam
Restoril Side Effects, and Drug Interactions - Temazepam
SIDE EFFECTS
During clinical studies
in which 1076 patients received temazepam at bedtime, the drug
was well tolerated. Side effects were usually mild and transient.
Adverse reactions occurring in 1% or more of patients are presented
in TABLE 1.
| TABLE 1 |
| Temazepam % incidence
(n=1076) |
Placebo % incidence
(n=783) |
|
|
|
9.1 |
5.6 |
|
|
8.5 |
9.1 |
|
|
4.8 |
4.7 |
|
|
4.6 |
8.2 |
|
|
4.5 |
3.4 |
|
|
4.5 |
3.8 |
|
|
3.1 |
3.3 |
|
|
2.5 |
1.1 |
|
|
2.0 |
1.5 |
|
|
1.7 |
1.8 |
|
|
1.7 |
2.2 |
|
|
1.7 |
1.1 |
|
|
1.5 |
1.9 |
|
|
1.5 |
0.4 |
|
|
1.4 |
0.9 |
|
|
1.3 |
0.5 |
|
|
1.3 |
1.3 |
|
|
1.2 |
1.7 |
|
|
1.2 |
0.8 |
The following adverse events have been reported less frequently
(0.5-0.9%):
Central Nervous System: anorexia, ataxia, equilibrium
loss, tremor, increased dreaming
Cardiovascular: dyspnea, palpitations
Gastrointestinal: vomiting
Musculoskeletal: backache
Special Senses: hyperhidrosis, burning eyes
Amnesia, hallucinations, horizontal
nystagmus, and paradoxical reactions including restlessness, overstimulation
and agitation were
rare (less than 0.5%).
DRUG ABUSE AND DEPENDENCE
Controlled Substance
Temazepam is a controlled substance
in Schedule IV.
Abuse and Dependence
Withdrawal symptoms, similar in character
to those noted with barbiturates and alcohol
(convulsions, tremor, abdominal, and muscle
cramps, vomiting, and sweating), have occurred following abrupt
discontinuance of benzodiazepines. 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. Consequently, after extended therapy
at doses higher than 15 mg, abrupt discontinuation should generally
be avoided and a gradual dosage
tapering schedule followed.
As with any hypnotic, caution must be exercised in administering
temazepam to individuals known to be addiction-prone or to those
whose history suggests they may increase the dosage
on their own initiative. It is desirable to limit repeated prescriptions
without adequate medical
supervision.
DRUG INTERACTIONS
The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed
according to labeling.
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