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Silenor Generic Name & Formulations
Legal Class
Rx
General Description
Doxepin (as HCl) 3mg, 6mg; tabs.
Pharmacological Class
H1 receptor antagonist.
How Supplied
Tabs—30, 100, 500
Manufacturer
Generic Availability
YES
Silenor Indications
Indications
Treatment of insomnia characterized by difficulty with sleep maintenance.
Silenor Dosage and Administration
Adult
Individualize. Take within 30mins of bedtime. Do not take within 3 hours of a meal. Initially 6mg once daily. Max: 6mg/day. Elderly, hepatic impairment, tendency to urinary retention: initially 3mg once daily.
Children
Not recommended.
Silenor Contraindications
Contraindications
During or within 14 days of MAOIs. Untreated narrow angle glaucoma. Severe urinary retention.
Silenor Boxed Warnings
Not Applicable
Silenor Warnings/Precautions
Warnings/Precautions
Evaluate for co-morbid diagnoses (eg, physical or psychiatric disorders) prior to treatment. Reevaluate if insomnia persists after 7–10 days of use. Monitor for new onset behavioral changes, worsening of depression, or suicidal thinking. Hepatic impairment. Respiratory dysfunction. Severe sleep apnea: not recommended. Poor metabolizers (those with reduced CYP2D6/2C19 activity). Reevaluate periodically. Elderly. Neonates (during 3rd trimester). Pregnancy. Nursing mothers: not recommended.
Silenor Pharmacokinetics
See Literature
Silenor Interactions
Interactions
Additive effects with concomitant CNS depressants, antihistamines, or alcohol (avoid); reduce dose. Potentiated by cimetidine. Possible hypoglycemia with tolazamide.
Silenor Adverse Reactions
Adverse Reactions
Somnolence, sedation, nausea, upper respiratory tract infection, dizziness, photosensitivity, skin rash; abnormal thinking, behavioral changes, complex behaviors, sleep-driving (discontinue if occurs), amnesia, anxiety, other neuro-psychiatric symptoms.
Silenor Clinical Trials
See Literature
Silenor Note
Not Applicable
Silenor Patient Counseling
See Literature
