DORA Medications for Insomnia: Brand and Generic Names
The FDA-approved medications for insomnia (DORA - Dual Orexin Receptor Antagonists and other classes) include zolpidem, zaleplon, eszopiclone, ramelteon, doxepin, and suvorexant, with cognitive behavioral therapy for insomnia (CBT-I) recommended as first-line treatment before pharmacological options. 1
First-Line Treatment
- CBT-I is strongly recommended as first-line treatment for chronic insomnia by the American Academy of Sleep Medicine and American College of Physicians due to superior long-term outcomes and fewer adverse effects 1
- Only consider medications when CBT-I is insufficient, unavailable, or patient is unwilling/unable to participate
FDA-Approved Medications for Insomnia
Benzodiazepine Receptor Agonist Modulators (Non-benzodiazepines)
Eszopiclone (Lunesta)
Zolpidem (Ambien)
Zolpidem CR (Ambien CR)
- Dosage: 12.5 mg at bedtime (6.25 mg in elderly)
- Controlled-release formulation for sleep maintenance 2
Zaleplon (Sonata)
Benzodiazepines
Estazolam
- Dosage: 1-2 mg at bedtime (0.5 mg in elderly)
- Short-to-intermediate acting 2
Temazepam (Restoril)
Triazolam (Halcion)
- Dosage: 0.25 mg at bedtime (0.125 mg in elderly)
- Short-acting 2
Flurazepam
- Dosage: 15-30 mg at bedtime (15 mg in elderly)
- Long-acting with risk of daytime drowsiness 2
Melatonin Receptor Agonists
- Ramelteon (Rozerem)
Dual Orexin Receptor Antagonists (DORAs)
- Suvorexant (Belsomra)
- Dosage: 10-20 mg at bedtime
- Indication: Sleep maintenance insomnia 1
Sedating Antidepressants
Doxepin (Silenor)
- Dosage: 3-6 mg at bedtime
- Indication: Sleep maintenance insomnia 1
Trazodone
- Off-label use for insomnia
- Low doses (25-100 mg) 1
Mirtazapine
- Off-label use for insomnia
- Low doses (7.5-15 mg) 1
Important Considerations and Cautions
Safety Concerns
- Benzodiazepines and non-benzodiazepine hypnotics are associated with:
Special Populations
Elderly patients:
Patients with substance use history:
- Prefer non-scheduled options like ramelteon or doxepin 1
Duration of Treatment
- Short-term use (4-5 weeks) is recommended for most sleep medications 1
- Eszopiclone is unique in not being limited to short-term use 4, 5
- Periodic medication-free intervals should be considered to assess continued need 1
Medication Selection Algorithm
For sleep onset insomnia:
- First choice: Zaleplon (shortest half-life)
- Second choice: Zolpidem or Ramelteon
- Third choice: Eszopiclone
For sleep maintenance insomnia:
- First choice: Eszopiclone or Suvorexant
- Second choice: Low-dose Doxepin
- Third choice: Temazepam (use with caution)
For both onset and maintenance insomnia:
- First choice: Eszopiclone
- Second choice: Zolpidem CR
- Third choice: Temazepam (use with caution)
For patients with risk of substance abuse:
- First choice: Ramelteon
- Second choice: Low-dose Doxepin
Remember to monitor patients for improvement in sleep parameters within 2-4 weeks of starting treatment and for potential side effects, particularly daytime sedation, falls, and cognitive changes 1.