1.1. Adults

Maximum recommended daily doses for sedative/hypnotics in adults, including the elderly population, are summarized in Table 1. Prescribed dosages exceeding these recommendations will be reviewed.

Table 1. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Benzodiazepines1-7
Drug Name Dosage Form/ Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
estazolam (generics) 1 mg, 2 mg tablets 2 mg 2 mg*
flurazepam (generics) 15 mg, 30 mg capsules 30 mg 15 mg*
temazepam (Restoril®, generics) 7.5 mg, 15 mg, 22.5 mg, 30 mg capsules 30 mg 30 mg*
triazolam (Halcion®, generics) 0.125 mg, 0.25 mg tablets 0.5 mg 0.25 mg*
quazepam (Doral®, generics) 15 mg tablets 15 mg 15 mg*

Legend:

  • * In elderly patients (patients greater than 65 years of age), sedative/hypnotic dosages should be reduced, if possible, as these patients are more sensitive to sedative/hypnotic pharmacologic/adverse effects24.
CaptionXXX
Drug Name Dosage Form/ Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
phenobarbital+ (generics) 15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg, 97.2 mg, 100 mg tablets; 20 mg/5 mL elixir 400 mg 400 mg*

Legend:

  • + No longer considered acceptable drug class to manage insomnia as safer agents (i.e., benzodiazepines, nonbarbiturates) are available25.
  • * In elderly patients (patients greater than 65 years of age), sedative/hypnotic dosages should be reduced if possible, as these patients are more sensitive to sedative/hypnotic pharmacologic/adverse effects24.
Table 3. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Non-Benzodiazepine, Benzodiazepine Receptor Agonists1,2,10-17
Drug Name Dosage Form/ Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
eszopiclone (Lunesta®, generics) 1 mg, 2 mg, 3 mg tablets 3 mg 2 mg
zaleplon (generics) 5 mg, 10 mg capsules 20 mg 10 mg
zolpidem immediate-release (IR) (Ambien®, generics) 5 mg, 10 mg IR tablets 10 mg 5 mg
zolpidem extended-release (ER) (Ambien CR®, generics) 6.25 mg, 12.5 mg ER tablets 12.5 mg 6.25 mg
zolpidem sublingual tablets (Edluar®) 5 mg, 10 mg sublingual tablets 10 mg 5 mg
zolpidem sublingual tablets (generics) 1.75 mg, 3.5 mg sublingual tablets 1.75 mg  (women)
3.5 mg  (men)		 1.75 mg
zolpidem lingual spray (Zolpimist®) 5 mg/ actuation 10 mg 5 mg
Table 4. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Melatonin Receptor Agonists1,2,18,19
Drug Name Dosage Form/Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
ramelteon (Rozerem®) 8 mg tablets 8 mg 8 mg
ramelteon (Rozerem®, generics) 8 mg tablets 8 mg 8 mg
Table 5. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Orexin Receptor Antagonists1,2,20-22
Drug Name Dosage Form/Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
daridorexant (Quviviq®) 25 mg, 50 mg 50 mg 50 mg
lemborexant (Dayvigo®) 5 mg, 10 mg tablets 10 mg 10 mg
suvorexant (Belsomra®) 5 mg, 10 mg 15 mg, 20 mg tablets 20 mg 20 mg
Table 6. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Miscellaneous Nonbarbiturates1,2,23
Drug Name Dosage Form/Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
doxepin (Silenor®, generics) 3 mg, 6 mg tablets 6 mg 6 mg

In the elderly, short- and intermediate-acting benzodiazepines (e.g., temazepam, triazolam) are preferred, as long-acting benzodiazepines (e.g., flurazepam) are associated with increased sedation and an increased risk of falls and fractures in this patient population.

The appropriate sedative/hypnotic dose for debilitated patients is the same as that prescribed in elderly patients for most sedative/hypnotic agents. However, estazolam 0.5 mg is used in small or debilitated geriatric patients, a dose lower than that recommended for elderly patients.

Doxepin is FDA-approved for use in managing insomnia characterized by difficulty in maintaining sleep. Studies have documented efficacy for up to 3 months in duration.

Patients with hepatic insufficiency have a reduced clearance of zolpidem. A 5 mg zolpidem immediate-release, sublingual (Edluar®), or oral spray (Zolpimist®) dose, a 1.75 mg sublingual tablet (Intermezzo®) dose, or a 6.25 mg extended-release dose is recommended in these patients.

Eszopiclone should be used cautiously in patients with severe hepatic impairment with initial doses of 1 mg daily at bedtime, as eszopiclone is significantly hepatically metabolized and serum concentrations may increase substantially in this patient population.

Suvorexant and lemborexant are newer sedative/hypnotics with a novel mechanism of action. Known as orexin receptor antagonists, suvorexant and lemborexant works by altering signaling of the orexin neurotransmitters in the brain. Orexins are responsible for regulating the sleep-wake cycle and helping to keep people awake. Suvorexant was FDA-approved in August 2014 as a schedule IV-controlled substance to manage insomnia associated with difficulties in sleep onset and/or sleep maintenance. Lemborexant was FDA-approved in December 2019 as a schedule IV-controlled substance for the treatment of insomnia characterized by difficulties with sleep onset and/ or sleep maintenance.

1.2. Pediatrics

Safety and efficacy of eszopiclone, ramelteon, zaleplon, zolpidem, daridorexant, lemborexant or suvorexant, as well as sedative/hypnotic benzodiazepines, have not been established in pediatric patients1-22. Barbiturates are no longer recommended for use in pediatric insomnia as safer, more effective agents are available.