Why Is Doxepin Discontinued

Doxepin (US brand name Sinequan® which has been discontinued and generic) is a tricyclic antidepressant. Low dose doxepin (Silenor® and generic) is used as a hypnotic. Here is basic information about this medication. Other articles on this website with more advanced information and tips related to this medication are linked to under Related Pages below.

Doxepin (Sinequan®)

FDA-approved indications

1. Psychoneurotic patients with depression and/or anxiety

2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)

3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)

4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders

Dosage

1. In adult patients with very mild symptomatology or emotional symptoms accompanying organic disease

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25-50 mg/day may be sufficient

2. In adult patients with mild to moderate severity illness

Initial: 75 mg/day

Titration: Increase/decrease dosage according to individual response

Usual: 75-150 mg/day

3. In adult patients with severe illness

Up to 300 mg/day after gradual dose increases

Prescribing Instructions

1. May be given in once daily or in divided dosage schedule.

2. If given once daily, then maximum recommended dose is 150 mg/day which may be given at bedtime. 150 mg/day capsule is offered only for maintenance therapy and not recommended for initiation of treatment.

3. Just prior to administration, oral concentrate should be diluted with approximately 120 mL of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice.

Dosage forms and strengths

Capsule: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg

Oral concentrate: 10 mg/mL

Please refer to Prescribing Information (see link below) for complete discussion of dosage, administration, warnings and precautions, contraindications, etc.

Doxepin (Silenor®)

FDA-approved indications

Treatment of insomnia characterized by difficulties with sleep maintenance

Dosage

Initial dose (adults): 6 mg once daily, taken within 30 minutes of bedtime

Initial dose (elderly): 3 mg once daily, taken within 30 minutes of bedtime

Maximum dose: 6 mg once daily

Patients should be instructed not to take Silenor® within 3 hours of a meal.

Dosage forms and strengths

Tablets: 3 mg and 6 mg

Potential side effects

Please see THIS PAGE for a handout listing both the common and less common side effects of this medication along with the percentages of patients who report them.

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Pharmacokinetics

According to the Flockhart table, doxepin is metabolized by cytochrome P450 enzymes 1A2, 2C9, 2C19, 2D6, and 3A4.

According to the Prescribing Information, doxepin is “primarily metabolized by hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9″.

Important! Please refer to the full Prescribing Information (see links below) before prescribing either preparation of doxepin.

Related Pages

Practical tips on using hypnotics: the Z drugs

Practical tips on using hypnotics: benzodiazepines

Relaxation Practice: A Simple and Powerful Tool for Anxiety, Tension, and Insomnia

Three important pieces of information about benzodiazepines

Sleep Hygiene worksheets-Part 1 and Part 2

Sleep log: Ten important questions about the person’s sleep

References

Doxepin (Sinequan®) Prescribing Information

Doxepin (Silenor®) Prescribing Information

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Disclaimer: The material on this website is provided as general education for medical professionals. It is not intended or recommended for patients or other laypersons or as a substitute for medical advice, diagnosis, or treatment. Patients must always consult a qualified healthcare professional regarding their diagnosis and treatment. Healthcare professionals should always check this website for the most recently updated information.

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