What FDA-approved medication is suitable for a non-elderly adult with chronic insomnia?

FDA-Approved Medications for Chronic Insomnia in Non-Elderly Adults

For a non-elderly adult with chronic insomnia, start with short-acting benzodiazepine receptor agonists (eszopiclone 2-3 mg, zolpidem 10 mg, or zaleplon 10 mg) or ramelteon 8 mg as first-line pharmacotherapy, but only after initiating Cognitive Behavioral Therapy for Insomnia (CBT-I), which remains the gold standard treatment. 1, 2

Treatment Algorithm

Step 1: Initiate CBT-I First

• CBT-I must be started before or alongside any medication, as it demonstrates superior long-term efficacy with sustained benefits after discontinuation compared to pharmacotherapy alone 1, 2
• CBT-I includes stimulus control therapy, sleep restriction therapy, relaxation techniques, and cognitive restructuring, and can be delivered through individual therapy, group sessions, telephone-based programs, or web-based modules 1
• Sleep hygiene education alone is insufficient as monotherapy but should supplement other CBT-I components 1, 2

Step 2: Select First-Line Pharmacotherapy Based on Sleep Pattern

For Sleep Onset Insomnia (difficulty falling asleep):

• Zaleplon 10 mg - very short half-life, minimal next-day sedation 1, 2, 3
• Zolpidem 10 mg - effective for both onset and maintenance 1, 2
• Ramelteon 8 mg - melatonin receptor agonist with zero addiction potential, ideal if substance abuse history exists 1, 2

For Sleep Maintenance Insomnia (difficulty staying asleep):

• Eszopiclone 2-3 mg - addresses both sleep onset and maintenance, with FDA approval for long-term use without duration restrictions 1, 2, 4
• Zolpidem 10 mg - effective for maintenance as well as onset 1, 2
• Low-dose doxepin 3-6 mg - specifically targets sleep maintenance with minimal anticholinergic effects at this dose 1, 2

For Combined Sleep Onset and Maintenance:

• Eszopiclone 2-3 mg is the preferred choice, as it consistently demonstrates efficacy for both components with moderate-to-large improvements in sleep quality and 28-57 minute increases in total sleep time 1, 4

Step 3: Second-Line Options if First-Line Fails

• Try an alternative benzodiazepine receptor agonist from the first-line options before moving to other classes 1
• Suvorexant (orexin receptor antagonist) can be considered for sleep maintenance insomnia 1, 2
• Sedating antidepressants (low-dose doxepin 3-6 mg, mirtazapine, or trazodone) may be considered, particularly if comorbid depression or anxiety exists 1, 2

Critical Safety Considerations

Mandatory Patient Education Before Prescribing

• Warn about complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating) that have been reported with all benzodiazepine receptor agonists 1, 5
• If a patient discovers they performed activities while not fully awake, stop the medication immediately 1
• Advise taking medication only when able to get 7-8 hours of sleep 1
• Avoid alcohol and other sedatives concurrently 1

Next-Day Impairment Risks

• Eszopiclone 3 mg causes psychomotor and memory impairment that persists up to 11.5 hours after dosing, even when patients don't subjectively feel impaired 4
• All hypnotics carry risks of daytime somnolence, driving impairment, and motor vehicle accidents 1, 5
• The FDA has mandated warnings about morning driving impairment for all benzodiazepine and nonbenzodiazepine hypnotics 1, 5

Monitoring Requirements

• Reassess after 1-2 weeks to evaluate efficacy on sleep latency, sleep maintenance, and daytime functioning 1
• Monitor for adverse effects including morning sedation, cognitive impairment, complex sleep behaviors, and falls 1
• Use the lowest effective dose for the shortest duration possible, with regular follow-up to assess continued need 1, 2

Medications to Explicitly Avoid

• Over-the-counter antihistamines (diphenhydramine) - not recommended due to lack of efficacy data, strong anticholinergic effects, and tolerance development after 3-4 days 1, 2
• Trazodone - explicitly NOT recommended by the American Academy of Sleep Medicine for sleep onset or maintenance insomnia, as harms outweigh minimal benefits 1, 2
• Antipsychotics (quetiapine, olanzapine) - should be avoided due to weak efficacy evidence and significant side effects including weight gain and metabolic syndrome 1, 2
• Traditional benzodiazepines (lorazepam, temazepam, triazolam) - not recommended as first-line due to higher risk of dependency, falls, cognitive impairment, and respiratory depression 1, 2
• Melatonin supplements, valerian, L-tryptophan - insufficient evidence of efficacy 1, 2

Common Pitfalls to Avoid

• Failing to initiate CBT-I before or alongside pharmacotherapy - medications should supplement, not replace, behavioral interventions 1, 2
• Prescribing medication without patient education about treatment goals, safety concerns, and potential side effects 1, 2
• Continuing pharmacotherapy long-term without periodic reassessment of ongoing need and effectiveness 1, 2
• Using sedating agents without considering their specific effects on sleep onset versus maintenance 1
• Combining multiple sedative medications, which significantly increases risks of complex sleep behaviors, cognitive impairment, falls, and fractures 1

Long-Term Use Considerations

• The FDA has approved all hypnotics since 2005 without restricting duration of use, recognizing that chronic insomnia often lasts longer than 2 years 5
• However, the American College of Physicians notes there is insufficient evidence to determine the balance of benefits and harms of long-term pharmacologic treatments beyond 4 weeks 1
• If continuing beyond 2 weeks, document why CBT-I alone is insufficient, use the absolute minimum effective dose, and implement periodic reassessments 1
• CBT-I can facilitate successful medication discontinuation when tapering is appropriate 1