How should I manage a 66‑year‑old woman with sleep‑maintenance insomnia who falls asleep but awakens after about two hours with a racing mind, has tried generic zolpidem (Ambien) and low‑dose quetiapine (Seroquel) without satisfactory relief, and lacks a DEA‑controlled‑substance license to prescribe Ambien?

Management of Sleep-Maintenance Insomnia in a 66-Year-Old Woman Without DEA License

Start low-dose doxepin 3–6 mg at bedtime, which is the most appropriate non-controlled medication for sleep-maintenance insomnia in older adults and does not require a DEA license. 1

Why Doxepin Is the Optimal Choice

• Low-dose doxepin (3–6 mg) specifically targets sleep-maintenance insomnia by blocking histamine H1 receptors without significant anticholinergic effects at these doses, demonstrating improvement in total sleep time, wake after sleep onset, and sleep quality in older adults. 1
• Doxepin is not a controlled substance, eliminating the DEA licensing barrier that prevents you from prescribing zolpidem or other benzodiazepine receptor agonists. 1
• The 3–6 mg dose is far below the antidepressant range (75–300 mg), minimizing anticholinergic burden and daytime sedation while maintaining efficacy for sleep maintenance. 1

Why Other Options Are Inappropriate

Zolpidem (Ambien)

• Zolpidem immediate-release primarily reduces sleep-onset latency but has inconsistent effects on sleep maintenance, making it poorly suited for her "awakening after 2 hours" pattern. 2, 3, 4
• Zolpidem extended-release 6.25 mg does improve sleep maintenance in elderly patients but requires DEA licensure as a Schedule IV controlled substance. 2, 5

Quetiapine (Seroquel)

• Quetiapine lacks systematic evidence for primary insomnia treatment and carries metabolic risks (weight gain, diabetes, dyslipidemia) that outweigh potential benefits in elderly patients without comorbid psychiatric illness. 1
• The American Academy of Sleep Medicine explicitly advises against antipsychotics as first-line insomnia treatment due to unfavorable risk-benefit profiles. 1

Over-the-Counter Antihistamines

• Diphenhydramine and hydroxyzine must be avoided in elderly patients due to anticholinergic effects that accelerate cognitive decline, cause daytime hypersomnolence, and increase fall risk. 1

Concurrent Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Even when prescribing medication, you must implement CBT-I components simultaneously, as behavioral interventions provide superior long-term outcomes and facilitate eventual medication tapering. 6, 1, 7

Sleep Restriction/Compression Protocol

• Have the patient complete a 1–2 week sleep log to calculate mean total sleep time (TST). 1
• Set time-in-bed (TIB) equal to calculated TST (minimum 5 hours, never less), with a consistent wake time. 1
• Adjust TIB weekly: increase by 15–20 minutes if sleep efficiency >85–90%; decrease by 15–20 minutes if <80%. 1

Stimulus Control Instructions

• Use the bedroom only for sleep and sex—no reading, TV, or phone use in bed. 1, 7
• Leave the bedroom if unable to fall asleep within 20 minutes after awakening; return only when sleepy. 1, 7
• Maintain consistent sleep and wake times seven days per week, including weekends. 1
• Eliminate daytime napping, which fragments nighttime sleep architecture. 1

Sleep Hygiene Modifications

• Keep the bedroom cool (60–67°F), dark, and quiet; use blackout curtains and white noise if needed. 1
• Avoid caffeine after noon, nicotine entirely, and alcohol within 3 hours of bedtime—alcohol fragments sleep in the second half of the night. 1, 7
• Avoid vigorous exercise within 2 hours of bedtime, though morning or afternoon exercise improves sleep. 1
• Limit fluids after 6 PM to reduce nocturia-related awakenings. 1

Relaxation Techniques

• Teach progressive muscle relaxation, diaphragmatic breathing, or guided imagery to reduce the "racing mind" she describes at 2 AM. 1, 7

Medication Review for Contributing Factors

Screen for medications that cause or worsen insomnia, as elderly patients often take multiple sleep-disrupting drugs. 1, 8

Common Culprits to Evaluate

• β-blockers (propranolol, metoprolol, atenolol) frequently cause insomnia and nightmares; consider switching to ACE inhibitors, ARBs, or calcium-channel blockers if treating hypertension. 1, 8
• Diuretics taken in the evening cause nocturia; shift administration to morning. 1, 8
• SSRIs (sertraline, fluoxetine, paroxetine) commonly cause or worsen insomnia; consider switching to mirtazapine if treating depression. 1, 8
• Bronchodilators, corticosteroids, and decongestants impair sleep when used for respiratory conditions. 1, 8

Dosing and Monitoring Protocol

Initial Prescription

• Start doxepin 3 mg orally 30 minutes before bedtime; may increase to 6 mg after 1 week if insufficient response. 1
• Dispense a 30-day supply to allow adequate trial duration. 1

Follow-Up Schedule

• Reassess at 2–4 weeks to evaluate effectiveness, side effects (morning grogginess, dry mouth), and adherence to CBT-I components. 1, 7
• Continue sleep log documentation throughout treatment to objectively track improvement. 1, 7
• Attempt medication tapering after 4–8 weeks once sleep consolidates, as CBT-I effects become self-sustaining. 1, 7

Critical Pitfalls to Avoid

• Do not prescribe hypnotics without concurrent CBT-I, as this leads to dependence without addressing underlying sleep architecture problems. 1, 7
• Do not assume sleep hygiene education alone will suffice—it must be combined with stimulus control and sleep restriction for chronic insomnia. 1, 7
• Do not overlook comorbid sleep disorders: screen for obstructive sleep apnea (snoring, witnessed apneas, morning headaches), restless legs syndrome (urge to move legs at night), and REM sleep behavior disorder (acting out dreams). 6, 8
• Do not use benzodiazepines (temazepam, lorazepam, clonazepam) even if you obtain DEA licensure, as they increase fall risk, cognitive impairment, and dementia incidence in elderly patients. 1

Alternative Non-Controlled Options If Doxepin Fails

Ramelteon 8 mg

• Ramelteon is a melatonin receptor agonist that does not require DEA licensure and may help with circadian rhythm regulation, though evidence for sleep maintenance is weaker than for doxepin. 6

Trazodone 25–50 mg

• Trazodone lacks systematic evidence for primary insomnia but is sometimes used off-label; however, it carries higher anticholinergic burden than low-dose doxepin and poses orthostatic hypotension risk. 1

Suvorexant (If You Obtain DEA License)

• Suvorexant 10 mg (elderly dose) is an orexin receptor antagonist with moderate-quality evidence for sleep-maintenance insomnia, but it requires DEA licensure as a Schedule IV drug. 1