What is the next step for an elderly female patient with insomnia who reports that trazodone (50 mg) is ineffective?

Next Step for Trazodone-Refractory Insomnia in an Elderly Female

Discontinue trazodone and transition to a first-line FDA-approved hypnotic such as low-dose doxepin (3-6 mg), eszopiclone (2-3 mg), or zolpidem (10 mg), while simultaneously referring for cognitive behavioral therapy for insomnia (CBT-I). 1, 2, 3

Why Trazodone Failed and Should Be Stopped

The American Academy of Sleep Medicine explicitly recommends against using trazodone for insomnia treatment, giving it a "WEAK" recommendation against use. 1, 3 The evidence demonstrates that:

• Trazodone 50 mg produces clinically insignificant improvements: only 10.2 minutes reduction in sleep onset, 21.8 minutes increase in total sleep time, and 7.7 minutes reduction in wake after sleep onset—all below clinical significance thresholds 2, 3
• No improvement in subjective sleep quality compared to placebo (difference of only -0.13 points on a 4-point scale) 3
• High adverse event rate: 75% of patients experience side effects versus 65.4% on placebo, including headache (30% vs 19%) and daytime somnolence (23% vs 8%) 2
• Particularly problematic in elderly patients due to increased risk of orthostatic hypotension, falls, and daytime drowsiness 2, 3

Do Not Increase the Dose

Increasing trazodone beyond 50 mg is not recommended for insomnia, as the evidence base for insomnia treatment is limited to 50 mg dosing. 1, 3 Higher doses (150-300 mg) are used for depression treatment, not insomnia, and would only increase adverse effects without established benefit for sleep. 4, 5

Recommended Treatment Algorithm

First Priority: Cognitive Behavioral Therapy for Insomnia (CBT-I)

• CBT-I should be the initial treatment for chronic insomnia and can be initiated now even if pharmacotherapy is continued temporarily 1
• Components include cognitive therapy, stimulus control therapy, and sleep restriction therapy with or without relaxation therapy 1

Second Priority: FDA-Approved First-Line Pharmacotherapy

The American Academy of Sleep Medicine recommends the following as superior alternatives to trazodone:

For sleep onset and maintenance insomnia:

• Eszopiclone 2-3 mg at bedtime 2, 3
• Zolpidem 10 mg at bedtime 2, 3
• Temazepam 15 mg at bedtime 2, 3

For sleep maintenance insomnia specifically (nocturnal awakenings):

• Doxepin 3-6 mg at bedtime is particularly suitable due to targeted efficacy for sleep maintenance and favorable side effect profile at low doses 2, 3
• Suvorexant 10-20 mg at bedtime 2

For sleep onset insomnia only:

• Zaleplon 10 mg at bedtime 3
• Ramelteon 8 mg at bedtime 3

Dosing Considerations for Elderly Patients

• Start with the lowest effective dose given increased sensitivity to sedative effects 1
• For doxepin, the 3-6 mg range is already the recommended dose and does not require further reduction 2
• Elderly patients require dose reduction consideration for most hypnotics due to fall risk 3

When Trazodone Might Be Reconsidered (Third-Line Only)

Trazodone should only be considered as a third-line agent after FDA-approved hypnotics and ramelteon have failed, or in specific scenarios: 1, 3

• Comorbid depression is present (though 50 mg is inadequate for treating major depression and would require 150-300 mg for antidepressant effect) 3, 4
• All first and second-line treatments have failed or are contraindicated 2

Critical Safety Counseling Points

When prescribing any hypnotic medication:

• Allow appropriate sleep time (7-8 hours) before needing to be alert 1
• Administer on an empty stomach to maximize effectiveness 1
• Counsel about sleep-related behaviors (sleepwalking, sleep driving) associated with sedative medications 1
• Use the lowest effective dose for the shortest duration 1
• Schedule regular follow-up every few weeks initially to assess effectiveness, side effects, and ongoing need 1

Common Pitfalls to Avoid

• Do not use trazodone as first-line therapy for primary insomnia 1
• Do not prescribe trazodone without attempting CBT-I or FDA-approved hypnotics first 1
• Do not use over-the-counter antihistamines or herbal supplements (valerian, melatonin) as alternatives—these lack efficacy and safety data for chronic insomnia 1
• Do not combine two sedating medications without careful consideration of additive effects 1