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 Indications, Dosage, Storage, Stability - Temazepam
Restoril Indications, Dosage, Storage, Stability - Temazepam
INDICATIONS
Temazepam is indicated for the short-term treatment
of insomnia (generally
7-10 days). For patients in whom the drug
is used for more than 2-3 weeks, periodic reevaluation is recommended
to determine whether there is a continuing need. (See WARNINGS.)
For patients with short-term insomnia, instructions in the prescription
should indicate that temazepam should be used for short periods
of time (7-10 days).
Temazepam should not be prescribed in quantities exceeding a 1-month
supply.
Insomnia is characterized by complaints of difficulty in falling
asleep, frequent nocturnal
awakenings, and/or early morning awakenings. Both sleep laboratory
and outpatient studies
provide support for
the effectiveness of temazepam administered 30 minutes before bedtime
in decreasing sleep latency and improving sleep
maintenance in patients with chronic
insomnia. In addition, sleep
laboratory studies have confirmed similar effects in normal subjects
with transient insomnia.
(See CLINICAL PHARMACOLOGY.)
DOSAGE AND ADMINISTRATION
While the recommended usual adult
dose is 15 mg before retiring,
7.5 mg may be sufficient for some patients, and others may need
30 mg. In transient insomnia, a 7.5 mg dose
may be sufficient to improve sleep
latency. In elderly and/or debilitated patients it is recommended that
therapy be initiated with 7.5 mg until individual responses are determined.
HOW SUPPLIED
Restoril® (temazepam) Capsules, USP
7.5 mg
Blue and pink, imprinted “Restoril 7.5 mg” and “FOR SLEEP” twice on each capsule. Bottle of 100,
NDC 0406-9915-01.
15 mg
Maroon and pink capsule imprinted “Restoril 15 mg” and “FOR SLEEP” twice on each capsule. Bottle of 100,
NDC 0406-9916-01; and bottle of 500, NDC 0406-9916-05.
30 mg
Maroon and blue capsule, imprinted “Restoril 30 mg” and “FOR SLEEP” twice on each capsule. Bottle of 100,
NDC 0406-9917-01; and bottle of 500, NDC 0406-9917-05.
Store and Dispense
Store in a tight, light-resistant container, below 86°F (30°C).
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