Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
IMPORTANT SAFETY INFORMATION
Silenor is contraindicated in individuals who have shown hypersensitivity to doxepin
HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects
and even death have been reported following the concomitant use of certain drugs
with MAO inhibitors (MAOIs). Do not administer Silenor if patient is currently on
MAOIs or has used MAOIs within the past two weeks. The exact length of time may
vary depending on the particular MAOI dosage and duration of treatment.
Silenor is contraindicated in individuals with untreated narrow angle glaucoma or
severe urinary retention.
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the
presence of a primary psychiatric and/or medical illness that should be evaluated.
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after
ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics.
These events can occur in hypnotic-naive as well as in hypnotic-experienced persons.
Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic
doses, the use of alcohol or other central nervous system depressants with hypnotics
appears to increase the risk of such behaviors, as does the use of hypnotics at
doses exceeding the maximum recommended dose. Due to the risk to the patient and
the community, discontinuation of Silenor should be strongly considered for patients
who report a "sleep-driving" episode. Other complex behaviors (i.e., preparing and
eating food, making phone calls, or having sex) have been reported in patients who
are not fully awake after taking a hypnotic. As with "sleep-driving", patients usually
do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms
may occur unpredictably.
Patients should not consume alcohol with Silenor. Patients should be cautioned about
potential additive effects of Silenor used in combination with CNS depressants or
In primarily depressed patients, worsening of depression, including suicidal thoughts
and actions (including completed suicides), has been reported in association with
the use of hypnotics. Doxepin, the active ingredient in Silenor, is an antidepressant
at doses 10- to 100-fold higher than in Silenor. Antidepressants increased the risk
compared to placebo of suicidal thinking and behavior in children, adolescents,
and young adults in short-term studies of major depressive disorder (MDD) and other
psychiatric disorders. Risk from the lower dose of doxepin in Silenor can not be
Patients should not take Silenor unless they are prepared to get a full night’s
sleep. After taking Silenor, patients should confine their activities to those necessary
to prepare for bed. Patients should avoid engaging in hazardous activities, such
as operating a motor vehicle or heavy machinery, at night after taking Silenor,
and should be cautioned about potential impairment in the performance of such activities
that may occur the day following ingestion.
For faster onset and to minimize the potential for next day effects, Silenor should
not be taken within 3 hours of a meal.
In clinical trials, the most common treatment-emergent adverse reaction was somnolence/sedation.
Silenor has not been studied in pregnant women. Silenor is excreted in human milk
after oral administration. Silenor is not approved for use in children.
Please see complete Prescribing Information before prescribing