A Good Day Starts at Night

Safety and tolerability1

SILENOR® is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

As with all medications, SILENOR® has some side effects. It’s important to discuss potential side effects with your patients when prescribing SILENOR®.

Patients should not take SILENOR®:

  • With alcohol
  • If they take other medications that can make them drowsy. Ask your patients about all of the medications they are taking so that you can determine if they can take SILENOR® along with these other medications.
  • If they cannot get a full night of sleep before becoming active again

Patients should not take SILENOR® if they:

  • Take a monoamine oxidase inhibitor (MAOI) medication or have taken an MAOI in the last 14 days (2 weeks)
  • Have narrow-angle glaucoma that is not being treated
  • Have severe urinary retention
  • Are allergic to any of the ingredients in SILENOR®. See the full Prescribing Information for a complete list of ingredients in SILENOR®.

After taking SILENOR®, patients may get up out of bed while not being fully awake and do an activity that they do not know they are doing, and not remember having done the next morning. Patients have a higher chance for doing these activities if they drink alcohol or take other medications that make them drowsy with SILENOR®. Reported activities include:

  • Driving a car (“sleep-driving”)
  • Making and eating food
  • Talking on the phone
  • Having sex
  • Sleep-walking

Instruct patients to contact you right away if they find out they have done any of the above activities after taking SILENOR®.

Before prescribing SILENOR®, you should determine whether your patient:

  • Has a history of depression, mental illness, or suicidal thoughts
  • Has severe sleep apnea
  • Has kidney or liver problems
  • Has a history of drug or alcohol abuse or addiction
  • Has a history of glaucoma or urinary retention
  • Has any other medical conditions
  • Is pregnant or plans to become pregnant (SILENOR® has not been studied in pregnant women)
  • Is breast-feeding or plans to breast-feed

These are not all the side effects of SILENOR®. Please see the full Prescribing Information for complete information.

SILENOR® is approved for use at 3 mg and 6 mg. Do not substitute: There is no generic SILENOR®.

The most common treatment-emergent adverse reaction—somnolence/sedation—is dose dependent1

Incidence (%) of treatment-emergent adverse reactions
in long-term, placebo-controlled clinical trials1
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graph
*

Includes reactions that occurred at a rate of ≥2% in any SILENOR®-treated group and at a higher rate than placebo.

Controlled clinical trials of SILENOR® demonstrated at recommended sleep-specific dose (3 mg and 6 mg)1

  • Minimal residual effects
  • No weight gain
  • No anticholinergic side effects
  • No effect on QTc interval, atrioventricular conduction, and new, clinically relevant morphological ECG changes

At doses higher than 6 mg, patients experienced

  • Anticholinergic side effects, such as constipation and urinary retention
  • Weight gain

Mechanism of action

SILENOR® is believed to work with the natural sleep-wake cycle by selectively blocking the H1 receptor, an important wake-promoting mechanism.1

Have a patient who may benefit from SILENOR>®

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Use our patient resources, including a sleep diary and questionnaire.

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 sedating antihistamines.

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® cannot be excluded.

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 full Prescribing Information before prescribing SILENOR®.