What is the best course of action for a 68-year-old male (YOM) with insomnia who is currently taking 150-200mg of trazodone (trazodone) at hour of sleep (HS) and continues to experience insomnia and restless leg syndrome (RLS)?

From the Guidelines

For a 68-year-old male with persistent insomnia and restless leg syndrome despite trazodone 150-200mg at bedtime, I recommend adding gabapentin 300mg at bedtime, as it may address both conditions, and considering alternative treatments for insomnia, given the limited efficacy and potential adverse effects of trazodone 1.

Key Considerations

• The patient's current treatment with trazodone has limited efficacy for insomnia, and its use is not recommended due to potential adverse effects 1.
• Gabapentin may be a suitable alternative, as it can address both insomnia and restless leg syndrome by modulating calcium channels and neurotransmitters 1.
• Non-pharmacological approaches, such as establishing a consistent sleep schedule, avoiding caffeine after noon, limiting evening screen time, and practicing relaxation techniques before bed, are equally important for managing insomnia.
• Iron levels should be checked, as iron deficiency can worsen restless leg syndrome, and supplementation may be necessary if ferritin is below 75 ng/mL 1.

Treatment Options

• Gabapentin 300mg at bedtime, which may address both insomnia and restless leg syndrome.
• Alternative treatments for insomnia, such as cognitive behavioral therapy for insomnia (CBT-I) or other non-pharmacological approaches, should be considered given the limited efficacy and potential adverse effects of trazodone 1.

Monitoring and Follow-up

• Regular follow-up appointments to monitor the patient's response to treatment and adjust the treatment plan as needed.
• Iron levels should be monitored, and supplementation should be considered if ferritin is below 75 ng/mL 1.

From the FDA Drug Label

1. Dosage and Administration 2. 1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. The dose may be increased by 50 mg/day every 3 to 4 days The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses.

The patient is currently taking 150-200mg of trazodone at bedtime, which is within the suggested initial dose range. However, since the patient is still experiencing insomnia and restless leg, the dose may be increased by 50mg/day every 3 to 4 days, up to a maximum of 400mg/day for outpatients, as tolerated by the patient and under close clinical supervision 2.

From the Research

Treatment of Insomnia and Restless Leg Syndrome

• The patient is currently taking 150-200mg of trazodone at bedtime for insomnia, but still experiences ongoing insomnia and restless leg syndrome 3.
• Trazodone has been shown to be effective in treating insomnia, including primary and secondary insomnia, with a low dose being generally safe and effective 3.
• However, the patient's restless leg syndrome may be a separate issue that needs to be addressed, as trazodone may not be directly effective in treating this condition.

Management of Restless Leg Syndrome

• Restless leg syndrome is a common disorder characterized by an uncomfortable urge to move the legs, especially at night, and can be primary or secondary to other conditions such as iron deficiency or chronic renal insufficiency 4, 5.
• First-line management options for restless leg syndrome include iron-replacement therapy, gabapentin, pregabalin, and dopamine agonists such as pramipexole, ropinirole, and rotigotine 4, 6.
• The patient's current treatment with trazodone does not seem to be exacerbating their restless leg syndrome, as sedating antidepressants like trazodone do not appear to aggravate periodic limb movements 7.

Potential Next Steps

• Consider evaluating the patient's iron levels and transferrin saturation to determine if iron-replacement therapy may be beneficial for their restless leg syndrome 4, 6.
• If the patient's restless leg syndrome is severe and interferes with their sleep, consider adding a dopamine agonist or an alpha2-delta ligand to their treatment regimen 6.
• Continue to monitor the patient's response to trazodone for insomnia and adjust the dose as needed, while also addressing their restless leg syndrome separately 3.