What are sleep medicine options for an NPO patient?

Comment by InpharmD Researcher

There are limited options to treat insomnia for patients that are designated NPO. Potential options include diphenhydramine, olanzapine, lorazepam, and diazepam, which are all available as an IV or IM formulation. Of note, none of these options are FDA-approved for treatment of insomnia, and their safety and efficacy for treatment of insomnia have not been evaluated in large, randomized controlled trials (see Table 1).

Background

A 2015 review identifies FDA-approved and off-label hypnotics used for insomnia. Authors do not specifically discuss agents that can be used for NPO patients; however, diphenhydramine, an antihistamine, is a non-FDA-approved option used for insomnia and is available in an IV formulation [1]. Diphenhydramine dosage should be individualized according to the needs and response of the patient. For adults, diphenhydramine should be dosed as 10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required (maximum daily dosage is 400 mg) [2]. Authors in a separate 2015 review mention olanzapine, an atypical antipsychotic, as a potential non-FDA-approved option for treatment of insomnia, which is available in an IV formulation [3]. The sedation associated with olanzapine results from its antagonistic effects on serotonin and histamine receptors. The effects of antipsychotics on sleep have been studied in patients with comorbid conditions, such as depression and psychosis; however, they have not been evaluated in subjects with primary insomnia. Olanzapine prescribing information provides dosing specifically for its FDA-approved indication of agitation associated with schizophrenia and bipolar I mania; off-label dosing for insomnia is not provided [4].

The FDA-approved benzodiazepines for insomnia (flurazepam, quazepam, temazepam and triazolam) are not available in non-oral formulations [1], [2], [3], [4], [5], [6], [7], [8], [9]; however, lorazepam was evaluated in a 2 mg dose using a 16-night protocol including 7 nights of drug trial in an observational study. Initially and with continued use, the drug was modestly effective in inducing and maintaining sleep (with an approximate reduction in total wake time of 20 minutes after 9 days. Withdrawal effects significantly reduced sleep from baseline after discontinuation (increase of approximately 40 minutes of wakefulness, p <0.01) [5]. Lorazepam is available as an IM and IV injection and is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness). For the primary purpose of sedation and relief of anxiety, the usual recommended initial dose of lorazepam for intravenous injection is 2 mg total, or 0.044 mg/kg, whichever is smaller. This dosage will be sedating in most adult patients. However, individualization of dosing, especially in those over 50 years of age should be considered [6].

Additionally, diazepam 10 mg has been evaluated in a sleep laboratory study (N= 6). With initial drug use, authors noted improvement in sleep, and there was little evidence of tolerance developing at the end of the 1-week drug administration period (not quantified) [7]. Diazepam is available as an IM and IV injection for the management of anxiety disorders. While dosing should be individualized for maximum beneficial effect, the initial recommended dose in older children and adults ranges from 2 mg to 20 mg intramuscular or intravenous, depending on the indication and its severity [8].

A study found a single intravenous dose of IV diphenhydramine provided safe and effective sedation in patients with cirrhosis. Sleep of 1 to 2 hr duration was induced in all subjects (n= 9) with a single 0.8 mg/kg IV dose. [10]

A 2016 systematic review analyzed the use of benzodiazepines, nonbenzodiazepine, sedatives, melatonin, propofol, and dexmedetomidine to reduce poor sleep in hospitalized patients (15 studies; N= 861 patients). The reviewers found no consistent trends concerning sleep efficiency, quality or interruptions. No specific agent or class was superior for improved sleep compared to each other or no treatment. Benzodiazepines had some success compared to no treatment with regards to sleep latency; however, this finding was inconsistent among included studies. [11]

References:

[1] Asnis GM, Thomas M, Henderson MA. Pharmacotherapy Treatment Options for Insomnia: A Primer for Clinicians. Int J Mol Sci. 2015;17(1):50. Published 2015 Dec 30. doi:10.3390/ijms17010050
[2] Diphenhydramine hydrochloride injection [prescribing information]. Fresenius Kabi USA, LLC; 2019
[3] Lie JD, Tu KN, Shen DD, Wong BM. Pharmacological Treatment of Insomnia. P T. 2015;40(11):759-771.
[4] Olanzapine injection [prescribing information]. Sandoz Inc; 2020
[5] Kales A, Bixler EO, Soldatos CR, Jacoby JA, Kales JD. Lorazepam: effects on sleep and withdrawal phenomena. Pharmacology. 1986;32(3):121-130. doi:10.1159/000138160
[6] Lorazepam injection [prescribing information]. Akorn, Inc.; 2021
[7] Kales A, Soldatos CR, Bixler EO, Kales JD, Vela-Bueno A. Diazepam: effects on sleep and withdrawal phenomena. J Clin Psychopharmacol. 1988;8(5):340-346.
[8] Diazepam injection [prescribing information]. Hikma Pharmaceuticals USA Inc.; 2021
[9] U.S. National Library of Medicine. DAILYMED. https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed January 5, 2022.
[10] Meredith CG, Christian CD Jr, Johnson RF, Madhavan SV, Schenker S. Diphenhydramine disposition in chronic liver disease. Clin Pharmacol Ther. 1984;35(4):474-479. doi:10.1038/clpt.1984.63
[11] Kanji S, Mera A, Hutton B, et al. Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016;6(7):e012108. Published 2016 Jul 29. doi:10.1136/bmjopen-2016-012108

Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

What are sleep medicine options for an NPO patient?

Level of evidence

D - Case reports or unreliable data  Read more→



Please see Table 1 for your response.


Off-Label Treatment Options for Insomnia for NPO Patients

Medication

FDA-Approved Indications and Usage Dosage and Administration for FDA-Approved Indications How Supplied

Diphenhydramine

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical: antihistaminic, motion sickness, and antiparkinsonism.

 

Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Pediatric patients, other than premature infants and neonates: 5 mg/kg/24 hr or 150 mg/m 2/24 hr. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

Adults: 10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required; maximum daily dosage is 400 mg.

Diphenhydramine hydrochloride Injection, USP in parenteral form is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride/mL of solution.

Olanzapine

Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania.

The efficacy of intramuscular (IM) olanzapine for injection in controlling agitation in these disorders was demonstrated in a dose range of 2.5 mg to 10 mg. The recommended dose in these patients is 10 mg. A lower dose of 5 or 7.5 mg may be considered when clinical factors warrant.

A dose of IM 5 mg/injection should be considered for geriatric patients or when other clinical factors warrant. A lower dose of 2.5 mg/injection should be considered for patients who otherwise might be debilitated, be predisposed to hypotensive reactions, or be more pharmacodynamically sensitive to olanzapine.

Olanzapine for injection is intended for IM use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.

Olanzapine for injection is available in 10 mg vials.

Lorazepam

Lorazepam injection is indicated for the treatment of status epilepticus and in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery.

 

Lorazepam must never be used without individualization of dosage particularly when used with other medications capable of producing central-nervous-system depression.

EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY SHOULD BE IMMEDIATELY AVAILABLE PRIOR TO INTRAVENOUS ADMINISTRATION OF LORAZEPAM.

For the treatment of status epilepticus, the usual recommended dose of lorazepam injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional lorazepam injection is required. If seizures continue or recur after a 10- to 15-minute observation period, an additional 4 mg intravenous dose may be slowly administered.

For the designated indications as a premedicant, the usual recommended dose of lorazepam for IM injection is 0.05 mg/kg up to a maximum of 4 mg. As with all premedicant drugs, the dose should be individualized. Doses of other central-nervous-system-depressant drugs ordinarily should be reduced.

There are insufficient data to support efficacy or make dosage recommendations for IM lorazepam in patients less than 18 years of age; therefore, such use is not recommended.

For the primary purpose of sedation and relief of anxiety, the usual recommended initial dose of lorazepam for intravenous injection is 2 mg total, or 0.02 mg/lb (0.044 mg/kg), whichever is smaller. This dose will suffice for sedating most adult patients and ordinarily should not be exceeded in patients over 50 years of age. In those patients in whom a greater likelihood of lack of recall for perioperative events would be beneficial, larger doses as high as 0.05 mg/kg up to a total of 4 mg may be administered.

Lorazepam injection, USP is available in the following dosage strengths: one carton containing ten 2 mg/mL single-dose vials and one carton containing ten 20 mg/10 mL (2 mg/mL) multi-dose vials.

Diazepam

Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis.

As an adjunct, prior to endoscopic procedures if apprehension, anxiety, or acute stress reactions are present, and to diminish the patient’s recall of the procedures.

Diazepam is a useful adjunct for the relief of skeletal muscle spasms due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus.

Diazepam injection is a useful adjunct in status epilepticus.

Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient’s recall of the procedure.

Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg intramuscular or intravenous, depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. In acute conditions, the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered.

Diazepam injection, USP is available as follows: 10 mg/2 mL single-dose prefilled disposable syringe packaged in cartons of ten.

References:

Diphenhydramine hydrochloride injection [prescribing information]. Mukilteo, WA: HF Acquisition Co LLC, DBA HealthFirst; 2020
Olanzapine injection [prescribing information]. Princeton, NJ: Sandoz Inc; 2020
Lorazepam injection [prescribing information]. Lake Forest, IL: Akorn, Inc.; 2021
Diazepam injection [prescribing information]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc.; 2021