Medications & Rx for Sleep Problems

Medications & Rx for Sleep Problems

Medications with Regulatory Approval for Insomnia

  • Benzodiazepine receptor agonists
    • Benzodiazepine hypnotics

    • Nonbenzodiazepine BZRAs

  • The newer dual-orexin-receptor antagonists
  • Histamine receptor antagonist (low-dose Hydroxyzine, or Doxepin)
  • Melatonin receptor agonists (Ramelteon)

Medications Prescribed Off-Label for Insomnia


  • Trazodone
  • Mirtazapine
  • Amitriptyline


Clinical use*

Preparations (brand



Sleep onset or sleep maintenance insomnia

Tablet (Lunesta)


Sleep onset insomnia

Capsule (Sonata)


Sleep onset or sleep maintenance insomnia

Tablet (Ambien),

sublingual tablet (Edluar),

oral liquid (Zolpimist; 5

mg per spray)

Zolpidem extended


Sleep onset or sleep

maintenance insomnia

Coated tablet (Ambien CR)

Zolpidem middle of the


Sleep maintenance

insomnia (middle of

the night)

Sublingual tablet (Intermezzo; 1.75 mg, 3.5 mg)

Zopiclone (not available

in the United States)

Sleep onset or sleep

maintenance insomnia


New – FDA Approves Daridorexant for Treatment of Insomnia

The FDA RECENTLY approved daridorexant (Quviviq, Idorsia Pharmaceuticals) for the treatment of individuals with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The properties of Daridorexant include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects,

The journal Lancet reported data on Daridorexant in two multicentre, randomised, double-blind, placebo-controlled, trials at 156 sites in 18 countries. Daridorexant reduced the wake time after sleep onset (the length of time when a person awakens after falling asleep) as compared to placebo, and that the 50 mg dose was more effective than the 25mg dose. Nasopharyngitis and headache were the most common adverse events in all groups.

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