Journal of Psychosocial Nursing and Mental Health Services

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FDA-Approved Drugs to Treat Sleep Disorders

Abstract

Table

Table

A handy source of up-to-date information on current medications for psychiatric illnesses

Generic (Brand) NameIndicationDrug InteractionsHabit FormingLong-Term Use

INSOMNIA

Doxepin (Silenor®)Insomnia characterized by difficulty with sleep maintenanceThe sedative effects of alcoholic beverages, sedating antihistamines, and other CNS depressants may be potentiated. Doxepin is metabolized by the hepatic cytochrome P450 enzymes CYP2C19, CYP2D6, CYP1A2, and CYP2C9. Drugs inhibiting these enzymes may increase serum concentrations of doxepin.NoClinical trials performed in support of efficacy were up to 3 months in duration.

Estazolam (ProSom®)Insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakeningsIncreased clearance and, thus, decreased estazolam levels in smokers; increased depressive effects when taken with alcohol and other CNS depressants; inhibitors of CYP450 3A4 could increase plasma levels of estazolam.Schedule IV drugaNot generally intended for long-term use.

Eszopiclone (Lunesta®)InsomniaIncreased depressive effects when taken with alcohol and other CNS depressants; inhibitors of CYP450 3A4 could increase plasma levels of eszopiclone; inducers of CYP450 3A4 could decrease plasma levels of eszopiclone.Schedule IV drugaNo development of tolerance seen in studies up to 6 months.

Flurazepam (Dalmane®)Insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings; recurring insomnia or poor sleeping habits; acute or chronic medical situations requiring restful sleepIncreased depressive effects when taken with alcohol and other CNS depressants; inhibitors of CYP450 3A4 could increase plasma levels of flurazepam; inducers of CYP450 3A4 could decrease plasma levels of flurazepam.Schedule IV drugaNot generally intended for long-term use; its longer half-life may cause daytime sedation and/or impaired motor/cognitive function (possibly progressively over time).

Quazepam (Doral®)Short-term treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakeningsIncreased depressive effects when taken with alcohol and other CNS depressants; inhibitors of CYP450 3A4 may increase effects of quazepam; inducers of CYP450 3A4 could decrease plasma levels of quazepam.Schedule IV drugaNot generally intended for use beyond 4 weeks; its longer half-life may cause daytime sedation and/or impaired motor/cognitive function (possibly progressively over time).

Ramelteon (Rozerem®)Insomnia (difficulty with sleep onset)Inhibitors of CYP450 1A2 may increase plasma levels of ramelteon; inducers of CYP450 could decrease plasma levels of ramelteon; inhibitors of CYP450 3A4 could increase plasma levels of ramelteon; inhibitors of CYP450 2C9 could increase plasma levels of ramelteon; use caution when combining with alcohol.NoNo reports of dependence, tolerance, or abuse liability; not restricted to short-term use, but few long-term studies exist.

Suvorexant (Belsomra®)InsomniaIncreased sedation/depressive effects when taken with alcohol and other CNS depressants; inhibitors of CYP450 3A4 could increase plasma levels of suvorexant; inducers of CYP450 3A4 could decrease plasma levels of suvorexant; food delays absorption.Schedule IV drugaClinical trials performed in support of efficacy were up to 3 months in duration.

Tasimelteon (Hetlioz®)Treatment of non-24-hour sleep-wake disorder in the totally blindInhibitors of CYP450 1A2 and CYP450 3A4 may increase plasma levels of tasimelteon; inducers of CYP450 3A4 may decrease plasma levels of tasimelteon.NoNo reports of dependence, tolerance, or abuse liability. Clinical trials in support of efficacy were up to 6 months in duration.

Temazepam (Restoril®)Short-term treatment of insomniaIncreased depressive effects when taken with alcohol and other CNS depressants.Schedule IV drugaNot generally intended for long-term use.

Triazolam (Halcion®)Short-term treatment of insomniaInhibitors of CYP450 3A4 may decrease clearance of triazolam, thus raising levels significantly; increased depressive effects when taken with alcohol and other CNS depressants; inducers of CYP450 3A4 could decrease plasma levels of triazolam.Schedule IV drugaNot generally intended for long-term use; increased wakefulness during the latter part of night (wearing off) or an increase in daytime anxiety (rebound) may occur.

Zaleplon (Sonata®)Short-term treatment of insomniaIncreased depressive effects when taken with alcohol and other CNS depressants; inducers of CYP450 3A4 may reduce the effectiveness of zaleplon.Schedule IV drugaNot generally intended for long-term use; increased wakefulness during the latter part of night (wearing off) or an increase in daytime anxiety (rebound) may occur.

Zolpidem tartrate (Ambien®, Ambien-CR®)Short-term treatment of insomnia (controlled release formula is not restricted to short-term use)Increased depressive effects when taken with alcohol and other CNS depressants.Schedule IV drugaIncreased wakefulness during the latter part of night (wearing off) or an increase in daytime anxiety (rebound) may occur.
(Edluar® sublingual tablets)Short-term treatment of insomnia characterized by difficulties with sleep initiationNot generally intended for long-term use.
(Intermezzo® sublingual tablets)Insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep
(Zolpimist® oral spray)Short-term treatment of insomnia characterized by difficulties with sleep initiation

NARCOLEPSY

Armodafinil (Nuvigil®)Narcolepsy; improve wakefulness from excessive sleepiness due to sleep apnea or shift work sleep disorderInhibitors of CYP450 3A4 and 3A5 will increase plasma levels.Schedule IV; may have some potential for abuseEfficacy established in 12-week studies

Dextro-amphetamine (Dexedrine®, Dexedrine Spansules®, Dextro Stat®)NarcolepsyMay increase blood pressure and heart rate so use cautiously with agents used to control blood pressure; agents with norepinephrine reuptake blocking properties can add to amphetamine's CNS and cardiovascular effects; amphetamines may counteract the sedative effects of other drugs; dopamine blocking drugs may inhibit amphetamine's stimulant effects; use with MAOI drugs in contraindicated.Schedule II drug; high abuse potential; patients may develop tolerance or psychological dependenceDependence and/or abuse may develop; some patients may develop tolerance to therapeutic effects; periodic monitoring of weight, blood pressure, complete blood count, platelet counts, and liver function may be sensible.
Mixed amphetamine salts (Adderall®)

Methylphenidate (Metadate ER®, Methylin ER®, Ritalin®, Ritalin SR®)NarcolepsyMay increase blood pressure and heart rate so use cautiously with agents used to control blood pressure; use with MAOI drugs is contraindicated.Schedule II drug; high abuse potential; patients may develop tolerance or psychological dependenceDependence and/or abuse may develop; some patients may develop tolerance to therapeutic effects; periodic monitoring of weight, blood pressure, complete blood count, platelet counts, and liver function may be sensible.

Modafinil (Provigil®, Alertec®, Modiodal®)Reducing excessive sleepiness in patients with narcolepsy and shift work sleep disorder and in patients with obstructive sleep apnea/hypopnea syndromeMay increase plasma levels of drugs metabolized by CYP450 2C19; may increase plasma levels of CYP450 2D6 substrates, possibly requiring downward dosage adjustments of these agents; may decrease plasma levels of CYP450 3A4 substrates; may reduce the effectiveness of steroidal contraceptives; inducers or inhibitors of CYP450 3A4 may affect modafinil levels; may slightly reduce its own levels by autoinduction of CYP450 3A4; may increase clearance of drugs dependent on CYP450 1A2 and reduce their plasma levels.Schedule IV drug; may have some potential for abuse but unusualEffectiveness in reducing excessive sleepiness in sleep disorders has been demonstrated in 9-week to 12-week trials; need for continued treatment should be reevaluated periodically.

Sodium oxybate (Xyrem®)Treatment of cataplexy in patients with narcolepsyIncreased depressive effects when taken with alcohol, benzodiazepines, sedative-hypnotic drugs, and other CNS depressants.Schedule III drug; high risk for abuseSodium oxybate is available only through the Xyrem Success Program®, using a centralized pharmacy, with recommended follow up every 3 months.
Authors

10.3928/02793695-20190903-79

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