Can Doxepin 10 mg Cause Withdrawal Symptoms If Stopped?
Yes, doxepin 10 mg can cause withdrawal symptoms if stopped abruptly, and the medication should be tapered gradually rather than discontinued suddenly. 1
Evidence from FDA Drug Labeling
The FDA-approved prescribing information for doxepin explicitly warns that "the possibility of development of withdrawal symptoms upon abrupt cessation of treatment after prolonged doxepin administration should be borne in mind." 1 The label clarifies that these withdrawal symptoms are not indicative of addiction, but emphasizes that gradual withdrawal of medication should be implemented to prevent these symptoms. 1
Mechanism and Drug Class Considerations
Doxepin is a tricyclic antidepressant (TCA), and withdrawal symptoms are well-established across this entire drug class. 2
Tricyclic antidepressants have the highest incidence of withdrawal symptoms among antidepressant classes at 59.7%, compared to SSRIs (45.6%) and SNRIs (29.7%). 2
The overall incidence of antidepressant withdrawal syndrome across all antidepressant classes is approximately 42.9-44.4%. 2
Clinical Characteristics of Withdrawal
Common withdrawal symptoms from tricyclic antidepressants include: 1
- Neurological: Numbness, paresthesias, dizziness, headache
- Gastrointestinal: Nausea, vomiting
- Psychiatric: Confusion, anxiety, irritability, insomnia, nightmares
- Physical: Sweating, chills, fatigue, flu-like symptoms
The FDA label for doxepin specifically lists paresthesias and numbness as adverse effects that can occur, which are consistent with discontinuation symptoms. 1
Risk Factors at 10 mg Dose
Even at the low dose of 10 mg, withdrawal risk exists, particularly if: 2
- The medication has been taken for longer durations (treatment >24 weeks has 51.4% withdrawal incidence vs. 35.1% for 6-12 weeks)
- The patient is female or younger
- The patient experienced adverse effects early in treatment
- Discontinuation is abrupt rather than tapered
Recommended Discontinuation Strategy
Gradual dose tapering is essential to minimize withdrawal symptoms. 1, 3
- Taper the dose over at least 2 weeks before complete discontinuation 4
- Drugs acting on the central nervous system, including tricyclic antidepressants, are specifically known to cause severe withdrawal symptoms when stopped abruptly 3
- If withdrawal symptoms occur despite tapering, reintroduce the medication and then withdraw more gradually 5
Important Clinical Pitfalls
Do not assume the low 10 mg dose eliminates withdrawal risk. While higher doses are associated with increased withdrawal symptoms 2, the FDA label does not specify a dose threshold below which withdrawal cannot occur. 1 The label notes that some patients are controlled on doses as low as 25-50 mg/day, suggesting that 10 mg represents a pharmacologically active dose that could lead to physiologic dependence with prolonged use. 1
Withdrawal symptoms typically begin within 24-48 hours of discontinuation, peak around day 5, and usually resolve within 2-3 weeks. 5 Most symptoms (65%) resolve within 7 days. 4