Non-Scheduled Drugs for Managing Insomnia
For patients with primary insomnia requiring pharmacological treatment, sedating antidepressants (trazodone, amitriptyline, doxepin, mirtazapine) are the recommended non-scheduled medications, especially when used in conjunction with treating comorbid depression/anxiety. 1
First-Line Approach
- Cognitive Behavioral Therapy for Insomnia (CBT-I) should be considered the initial treatment for chronic insomnia before or alongside pharmacological options 1, 2
- When pharmacotherapy is necessary, treatment selection should be guided by symptom pattern, treatment goals, past responses, patient preference, cost, and comorbid conditions 1
Recommended Non-Scheduled Medications
Sedating Antidepressants
- Trazodone, amitriptyline, doxepin, and mirtazapine are the primary non-scheduled options for insomnia management 1, 3
- Doxepin liquid (3-6 mg) is particularly effective for sleep maintenance insomnia and available in liquid form 4
- Mirtazapine can be beneficial for patients with comorbid depression and insomnia 3, 4
- Trazodone (typically 50 mg) is commonly used though evidence is more limited compared to other options 3, 4
Other Non-Scheduled Options
- Anti-epilepsy medications (gabapentin, tiagabine) may be considered for patients with comorbid conditions that would benefit from their primary action 1, 3
- Atypical antipsychotics (quetiapine, olanzapine) should only be used in patients with comorbid psychiatric conditions that would benefit from their primary mechanism of action 1, 3
- Melatonin, while available over-the-counter, is not strongly recommended by guidelines for primary insomnia due to limited efficacy data 1, 5
Medications to Avoid
- Over-the-counter antihistamine sleep aids are not recommended due to lack of efficacy and safety data 1
- Herbal substances such as valerian are not recommended due to insufficient evidence 1
- Older drugs including barbiturates, barbiturate-type drugs, and chloral hydrate are not recommended 1
Administration Guidelines
- Start with the lowest effective dose and titrate as needed 1
- Pharmacological treatment should be accompanied by patient education regarding treatment goals, safety concerns, potential side effects, and other treatment modalities 1
- Regular follow-up is essential to assess effectiveness, monitor for side effects, and evaluate the ongoing need for medication 1
- Efforts should be made to use the lowest effective maintenance dosage and to taper medication when conditions allow 1
Special Considerations
- For patients requiring administration through PEG tubes, doxepin liquid is ideal; alternatively, trazodone and mirtazapine can be crushed and dissolved in water 4
- In elderly patients, lower doses should be used due to increased sensitivity to side effects 3, 4
- For patients with a history of substance use disorders, non-scheduled medications are preferred over controlled substances 3, 6
Monitoring and Follow-up
- Assess efficacy after 1-2 weeks of treatment initiation 4
- Monitor for side effects including excessive sedation, confusion, and falls, especially in elderly patients 4, 6
- Long-term prescribing should include consistent follow-up, ongoing assessment of effectiveness, and monitoring for adverse effects 1