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.
| 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.
| 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.
| 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; 7.5 mg capsules | 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 (females) 3.5 mg (males) | 1.75 mg |
| 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 |
| 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 |
| 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.
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.