Slipaid 6 mg (Tablet)

Indications

• Treatment of insomnia characterized by difficulty with sleep maintenance
• Clinical trials up to 3 months in duration

Pharmacology

• Binds with high affinity to the histamine H1 receptor
• Functions as an antagonist to the H1 receptor

Dosage & Administration

• Recommended dose of 6 mg once daily for adults
• Recommended starting dose of 3 mg once daily for elderly patients
• Should be taken within 30 minutes of bedtime
• Should not be taken within 3 hours of a meal
• Total dose should not exceed 6 mg per day
• Pediatric use safety and effectiveness not evaluated

Interaction

• Metabolized by CYP2C19, CYP2D6, CYP1A2, and CYP2C9
• Exposure increased with inhibitors of CYP isozymes
• Exposure doubled with concomitant administration of cimetidine
• Potentiated sedative effects with alcohol, CNS depressants, sedating antihistamines
• Reported severe hypoglycemia in a diabetic patient with tolazamide

Contraindications

• Contraindicated in hypersensitivity to doxepin HCl or its inactive ingredients
• Contraindicated in co-administration with MAOIs
• Contraindicated in untreated narrow-angle glaucoma or severe urinary retention

Side Effects

• Abnormal thinking and behavioral changes
• Suicide risk and worsening of depression
• CNS depressant effects

Pregnancy & Lactation

• Pregnancy Category C
• Use during pregnancy if benefit justifies risk to fetus
• Excreted in human milk after oral administration
• Caution in nursing women

Precautions & Warnings

• Need to evaluate for comorbid diagnoses before treatment
• Risk of abnormal thinking and behavioral changes
• Suicide risk and worsening of depression precautions
• Discontinuation considerations for complex behaviors
• Need for evaluation in case of neuro-psychiatric symptoms

Therapeutic Class

• Tricyclic & related anti-depressant drugs

Storage Conditions

• Keep below 30°C temperature
• Away from light & moisture
• Keep out of the reach of children

Related Brands

• Slipaid 3 mg (Tablet) - beacon-pharmaceuticals-plc