What is the recommended treatment for an adult with difficulty falling or staying asleep who has no contraindications such as severe liver disease, pregnancy, untreated obstructive sleep apnea, or a history of substance misuse?

First-Line Treatment for Adult Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) must be initiated as the first-line treatment for all adults with chronic insomnia before or alongside any medication, as it provides superior long-term efficacy with sustained benefits after treatment ends. 1, 2

Immediate Non-Pharmacologic Intervention

• Start CBT-I immediately – this is a strong recommendation from both the American Academy of Sleep Medicine and the American College of Physicians, demonstrating better outcomes than medication alone with no side effects 1, 3
• CBT-I includes five core components: stimulus control (leave bed if unable to sleep within 20 minutes), sleep restriction (limit time in bed to actual sleep time plus 30 minutes), cognitive restructuring of negative sleep thoughts, relaxation techniques (progressive muscle relaxation, guided imagery), and sleep hygiene education 1, 2
• CBT-I can be delivered through individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books – all formats show comparable effectiveness 1

First-Line Pharmacotherapy (Only After CBT-I Initiation)

When medication is necessary after starting CBT-I, the choice depends on the specific insomnia pattern:

For Sleep-Onset Difficulty (Trouble Falling Asleep)

• Zolpidem 10 mg (5 mg if age ≥65 years) taken within 30 minutes of bedtime with at least 7 hours remaining before awakening – reduces sleep latency by ~25 minutes and increases total sleep time by ~29 minutes 1, 4
• Zaleplon 10 mg (5 mg if age ≥65 years) for rapid sleep initiation with minimal next-day sedation due to its ultrashort 1-hour half-life 1
• Ramelteon 8 mg – a melatonin receptor agonist with no abuse potential, no DEA scheduling, and no withdrawal symptoms, making it ideal for patients with substance use history 1

For Sleep-Maintenance Difficulty (Waking During the Night)

• Low-dose doxepin 3–6 mg is the preferred first-line option – reduces wake after sleep onset by 22–23 minutes with minimal anticholinergic effects at these doses and no abuse potential 1, 5
• Suvorexant 10 mg (orexin receptor antagonist) reduces wake after sleep onset by 16–28 minutes with lower cognitive and psychomotor impairment risk than benzodiazepine-type agents 1, 5

For Combined Sleep-Onset and Maintenance Problems

• Eszopiclone 2–3 mg (1 mg if age ≥65 years or hepatic impairment) increases total sleep time by 28–57 minutes and improves both sleep onset and maintenance 1, 5
• Take within 30 minutes of bedtime with at least 7 hours remaining before planned awakening 1

Treatment Algorithm

1. Initiate CBT-I immediately for all patients with chronic insomnia – this is mandatory, not optional 1, 3
2. Assess the primary sleep complaint: difficulty falling asleep (onset), staying asleep (maintenance), or both 1
3. If CBT-I alone is insufficient after 4–8 weeks, add first-line pharmacotherapy matched to the insomnia pattern 1
4. Reassess after 1–2 weeks to evaluate sleep-onset latency, total sleep time, nocturnal awakenings, daytime functioning, and adverse effects 1
5. If the first agent fails, switch to an alternative within the same class before moving to second-line options 1
6. Use the lowest effective dose for the shortest duration (typically ≤4 weeks for acute insomnia per FDA labeling) 1

Medications Explicitly NOT Recommended

• Trazodone – provides only ~10 minutes reduction in sleep latency with no improvement in subjective sleep quality; adverse events occur in ~75% of older adults 1
• Over-the-counter antihistamines (diphenhydramine, doxylamine) – lack efficacy data, cause strong anticholinergic effects (confusion, urinary retention, falls), and develop tolerance within 3–4 days 1
• Traditional benzodiazepines (lorazepam, clonazepam, diazepam) – long half-lives lead to drug accumulation, daytime sedation, higher fall and cognitive impairment risk, and associations with dementia and fractures 1
• Antipsychotics (quetiapine, olanzapine) – weak evidence for benefit with significant risks including weight gain, metabolic dysregulation, and increased mortality in elderly with dementia 1
• Melatonin supplements – produce only ~9 minutes reduction in sleep latency with insufficient efficacy evidence 1

Critical Safety Warnings

• All benzodiazepine receptor agonists carry FDA warnings for complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating); discontinue immediately if these occur 1
• Avoid alcohol while using any hypnotic – markedly increases risk of complex sleep behaviors and respiratory depression 1
• Next-day impairment can occur even when patients feel fully awake; avoid driving or operating machinery until response is known 1, 4
• Falls, fractures, and cognitive decline are increased with all hypnotics, especially in adults ≥65 years 1

Common Pitfalls to Avoid

• Starting medication without first implementing CBT-I – forfeits the more durable benefits of behavioral therapy 1
• Using adult dosing in older adults – age-adjusted dosing (e.g., zolpidem ≤5 mg, eszopiclone ≤2 mg for age ≥65 years) is essential to reduce fall risk 1
• Combining multiple sedative agents – markedly increases risk of respiratory depression, cognitive impairment, falls, and complex sleep behaviors 1
• Continuing pharmacotherapy long-term without reassessment – FDA labeling indicates short-term use; evidence beyond 4 weeks is limited 1
• Prescribing agents without matching their profile to the insomnia phenotype – use zaleplon for onset only, doxepin for maintenance only, and eszopiclone for combined symptoms 1