Non-Scheduled Drugs for Managing Insomnia

First-Line Approach

The American Academy of Sleep Medicine recommends Cognitive Behavioral Therapy for Insomnia (CBT-I) as the initial treatment for chronic insomnia before or alongside pharmacological options 1, 3
When pharmacotherapy is necessary, treatment selection should be guided by symptom pattern, treatment goals, past responses, patient preference, cost, and comorbid conditions 1, 2

Sedating antidepressants, such as trazodone, amitriptyline, doxepin, and mirtazapine, are the primary non-scheduled options for insomnia management, especially when used in conjunction with treating comorbid depression/anxiety 1, 2
Doxepin liquid (3-6 mg) is particularly effective for sleep maintenance insomnia and available in liquid form 5
Mirtazapine can be beneficial for patients with comorbid depression and insomnia 4, 5
Trazodone (typically 50 mg) is commonly used though evidence is more limited compared to other options 4, 5

The American Academy of Sleep Medicine does not recommend over-the-counter antihistamine sleep aids due to lack of efficacy and safety data 1, 2
Herbal substances such as valerian are not recommended due to insufficient evidence 1, 3

The American Academy of Sleep Medicine recommends starting with the lowest effective dose and titrating as needed 1, 2
Pharmacological treatment should be accompanied by patient education regarding treatment goals, safety concerns, potential side effects, and other treatment modalities 1, 2

For patients requiring administration through PEG tubes, doxepin liquid is ideal; alternatively, trazodone and mirtazapine can be crushed and dissolved in water 5
In elderly patients, lower doses should be used due to increased sensitivity to side effects 4, 5

Assess efficacy after 1-2 weeks of treatment initiation 5
Long-term prescribing should include consistent follow-up, ongoing assessment of effectiveness, and monitoring for adverse effects 1, 2