SONATA- zaleplon capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)

Pieejams no:

Pfizer Laboratories Div Pfizer Inc

SNN (starptautisko nepatentēto nosaukumu):

ZALEPLON

Kompozīcija:

ZALEPLON 5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment. Hypersensitivity to zaleplon or any excipients in the formulation (see also PRECAUTIONS ). Sonata is classified as a Schedule IV controlled substance by federal regulation. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation

Produktu pārskats:

Sonata (zaleplon) capsules are supplied as follows: Sonata® is a registered trademark of King Pharmaceuticals Research and Development, Inc. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Dispense in a light-resistant container as defined in the USP.

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

SONATA- ZALEPLON CAPSULE
Pfizer Laboratories Div Pfizer Inc
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MEDICATION GUIDE
SONATA® (Suh NAH tah) CAPSULES
C-IV
(Zaleplon CAPSULES)
Read this Medication Guide before you start taking SONATA and each
time you get a refill. There may
be new information. This Medication Guide does not take the place of
talking to your doctor about your
medical condition or treatment. You and your doctor should talk about
SONATA when you start taking it
and at regular checkups.
What is the most important information I should know about SONATA?
After taking SONATA, you may get up out of bed while not being fully
awake and do an activity that you
do not know you are doing. The next morning, you may not remember that
you did anything during the
night. You have a higher chance for doing these activities if you
drink alcohol or take other medicines
that make you sleepy with SONATA. Reported activities include:
• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking
Important:
1. Take SONATA exactly as prescribed
• Do not take more SONATA than prescribed.
• Take SONATA right before you get in bed, not sooner.
2. Do not take SONATA if you:
• drink alcohol
• take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines. Your
doctor will tell you if you can take SONATA with your other medicines
• cannot get a full night's sleep
3. Call your doctor right away if you find out that you have done any
of the above activities after taking
SONATA.
What is SONATA?
SONATA is a sedative-hypnotic (sleep) medicine. SONATA is used in
adults for the short-term treatment
of the symptom of trouble falling asleep from insomnia. SONATA does
not treat other symptoms of
insomnia which include waking up too early in the morning and waking
up often during the night.
SONATA is not for children.
SONATA is a federally controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep SONATA in a safe place to prevent misuse and abuse.

Produkta apraksts

SONATA- ZALEPLON CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
----------
SONATA
(ZALEPLON)
CAPS ULES
CIV
RX ONLY
DESCRIPTION
Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine
class. The chemical name of
zaleplon is
N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide.
Its empirical
formula is C
H N O, and its molecular weight is 305.34. The structural formula is
shown below.
Zaleplon is a white to off-white powder that is practically insoluble
in water and sparingly soluble in
alcohol or propylene glycol. Its partition coefficient in
octanol/water is constant (log PC = 1.23) over
the pH range of 1 to 7.
Sonata
capsules contain zaleplon as the active ingredient. Inactive
ingredients consist of
microcrystalline cellulose, pregelatinized starch, silicon dioxide,
sodium lauryl sulfate, magnesium
stearate, lactose, gelatin, titanium dioxide, D&C yellow #10, FD&C
blue #1, FD&C green #3, and
FD&C yellow #5.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS AND MECHANISM OF ACTION
While Sonata (zaleplon) is a hypnotic agent with a chemical structure
unrelated to benzodiazepines,
barbiturates, or other drugs with known hypnotic properties, it
interacts with the gamma-aminobutyric
acid-benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of
the GABA-BZ receptor
chloride channel macromolecular complex is hypothesized to be
responsible for some of the
pharmacological properties of benzodiazepines, which include sedative,
anxiolytic, muscle relaxant,
and anticonvulsive effects in animal models.
®
17
15
5
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Other nonclinical studies have also shown that zaleplon binds
selectively to the brain omega-1 receptor
situated on the alpha subunit of the GABA /chloride ion channel
receptor complex and potentiates t-
butyl-bicyclophosphorothionate (TBPS) binding. Studies of binding of
zaleplon to recombinant GABA
receptors (α β γ [omega-1] and α β γ [omega-2]) have shown that
zaleplon has a low affinity for
these receptors, with preferential binding to the omega-1 receptor.
PHARMACOKINETICS
The phar