Medications Indicated for Adult Insomnia

First-Line Treatment

The American Academy of Sleep Medicine recommends Cognitive Behavioral Therapy for Insomnia (CBT-I) as the standard of care for all adults with chronic insomnia, demonstrating superior long-term efficacy compared to pharmacotherapy 1, 2, 3
CBT-I delivery methods include individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books, all showing effectiveness 1, 2
CBT-I components include stimulus control therapy, sleep restriction therapy, cognitive restructuring, relaxation training, and sleep hygiene education 1, 2

The American Academy of Sleep Medicine recommends short/intermediate-acting benzodiazepine receptor agonists (BzRAs) or ramelteon as first-line options for pharmacotherapy when CBT-I is insufficient or unavailable 1, 4
Eszopiclone 2-3 mg shows moderate-quality evidence for improvement in both sleep onset latency and total sleep time 1, 4
Zolpidem 10 mg (5 mg in elderly) has low to moderate-quality evidence for both sleep onset and maintenance 1, 4

Sedating antidepressants, such as mirtazapine, low-dose doxepin, and amitriptyline, are preferred initial pharmacologic choices for patients with comorbid depression or anxiety 4, 5

The American Academy of Sleep Medicine does not recommend trazodone due to cardiac risks, lack of efficacy data, and morning grogginess 4, 5
Over-the-counter antihistamines, such as diphenhydramine and doxylamine, are not recommended due to lack of efficacy data, daytime sedation, confusion, urinary retention, and tolerance development 4, 5

Elderly patients (≥65 years) should receive zolpidem 5 mg maximum due to increased sensitivity, fall risk, and cognitive impairment 4, 5
Patients with substance abuse history should receive ramelteon 8 mg as the only appropriate first-line choice due to zero addiction potential and non-DEA scheduled status 4, 5

All hypnotic medications carry FDA warnings about serious adverse effects, including complex sleep behaviors, daytime impairment, falls and fractures, cognitive impairment, worsening depression, dependence, and withdrawal 1, 4

Use the lowest effective dose for the shortest duration possible (typically less than 4 weeks for acute insomnia) 1, 4, 5
Pharmacotherapy should supplement, not replace, CBT-I 1, 4, 5
Reassess after 1-2 weeks to evaluate efficacy on sleep latency, maintenance, daytime functioning, and adverse effects 4, 5