1 © MIMS

Insomnia (1 of 13)

Not all products are available or approved for above use in all countries.Specifi c prescribing information may be found in the latest MIMS.

1Patient presents w/ insomnia associated w/

daytime dysfunction

2DIAGNOSISIs insomnia confi rmed?

No ALTERNATIVE DIAGNOSIS

• Treat underlying cause or comorbid disorder

• Consider treatment of symptoms causing insomnia

See Principles of � erapy

3EVALUATION

Does the insomnia persist for >3

months?

SHORTTERM

INSOMNIASee next page for

management

CHRONIC INSOMNIA

See next page for management

3EVALUATION

Is there an underlying cause for the insomnia or a comorbid

disorder that should be addressed?

Insomnia (2 of 13)

SHORTTERM INSOMNIA

C Follow-up

CHRONIC INSOMNIA

C Follow-up

A Non-pharmacological therapyCognitive behavioral therapy for insomnia • Sleep hygiene education• Relaxation therapy• Stimulus control therapy • Sleep restriction therapy • Paradoxical intention• Cognitive therapy Other Behavioral Interventions• Lifestyle changes

B Pharmacological therapy• Benzodiazepines (intermittent use, for ≤4 weeks) • Non-benzodiazepine hypnotics (intermittent use,

for ≤4 weeks)

A Non-pharmacological therapy Cognitive behavioral therapy for insomnia • Sleep hygiene education • Relaxation therapy • Stimulus control therapy• Sleep restriction therapy • Paradoxical intention• Cognitive therapyOther Behavioral Interventions• Lifestyle changes

B Pharmacological therapy • Melatonin receptor agonists • Benzodiazepines (intermittent use, for ≤4 weeks) • Non-benzodiazepine hypnotics (intermittent use,

for only ≤4 weeks)

Insomnia (3 of 13)

1 INSOMNIA

• � e subjective perception of diffi culty in sleep initiation, duration, consolidation, or quality of sleep, occurring despite adequate opportunities for sleep, & resulting in daytime dysfunction

• Insomnia is the most prevalent sleep disorder in the general population, therefore, it is an important public health problem that needs accurate diagnosis & eff ective treatment

• Approximately 6-10% of adults have insomnia & it is more common in females & older adults- 30-50% of the population is aff ected by occasional, short-term insomnia- � e prevalence of chronic insomnia disorder is estimated to be at least 5-10% in industrialized nations

2 DIAGNOSIS

Diagnostic Criteria• Based on DSM-5 criteria, a diagnosis of insomnia is made if there is a predominant complaint of dissatisfi ed

sleep related to its quantity or quality associated w/ at least one of the following symptoms:- Having trouble w/ sleep initiation or maintenance; in children, this is manifested as having trouble w/ sleep

without the caregiver’s intervention- Interrupted sleep (eg frequent awakenings or early-morning awakening) w/ diffi culty returning to sleep

afterwards• Also, DSM-5 criteria stated that the sleeping diffi culty:

- Causes distress or impairment in signifi cant areas of functioning (eg social, occupational, educational, academic, behavioral)

- Occurs ≥3 nights per week- Lasts for ≥3 months- Occurs even though there is suffi cient opportunity for sleep

• � e insomnia is not due to & does not happen during another sleep-wake disorder (eg narcolepsy, a breath-ing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia)

• � e symptoms are not caused by eff ects of substance or medication• � e disturbance is not associated w/ coexisting mental disorders & medical conditions• May specify insomnia if w/ non-sleep disorder mental comorbidity, w/ other medical comorbidity or w/ other

sleep disorder• Insomnia may be specifi ed further as:

- Episodic where symptoms occur for at least a month but less than 3 months - Persistent where symptoms occur for ≥3 months- Recurrent where ≥2 episodes occur within a span of a year

• Insomnia lasting for <3 months that meets the criteria for insomnia disorder in regards to frequency, intensity, signifi cant distress &/or impairment should be considered under the other specifi ed insomnia disorder

Evaluation• Comprehensive clinical history & physical examination that evaluate sleep & waking function of the patient

- Sleep history includes sleep habits, sleep environment, work schedules, circadian factors- Determine the onset, duration, frequency, severity, course & perpetuating factors- Ask about past & current treatments & response of the patient- Screen for physical symptoms such as pain, nocturia, shortness of breath, itch, paresthesia, refl ux, restlessness

or general discomfort, which may disrupt sleep• Common medical, psychiatric, & medication/substance-related comorbidities should also be assessed• Self-administered questionnaires, sleep log, symptom checklists, psychologic screening tests & interviews w/

bed partner are some of the instruments that help arrive at the proper diagnosis- Ask patient to keep a sleep diary - May use questionnaires such as Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI),

Morningness-Eveningness Questionnaire (MEQ)- ISI is a self-report tool which measures perceived severity of insomnia & has been shown to be a valid &

reliable tool to detect patients w/ insomnia- PSQI may be used to evaluate subjective sleep during the previous month - MEQ is for assessment of circadian factor

• Polysomnography can be used: - To evaluate other suspected sleep disorders (ie periodic limb movement disorder)- In treatment-resistant insomnia- For professional at-risk populations - When substantial sleep state misperception is suspected

Insomnia (4 of 13)

3 EVALUATION

Short-Term Insomnia Disorder• Symptoms are present for <3 months• Also referred to as adjustment insomnia or acute insomnia• Presence of insomnia associated w/ an identifi able stressor• Sleep disturbance has a relatively short duration, occurring days to weeks, & is expected to resolve when the

stressor resolves or when individual is able to adapt• Associated w/ unfamiliar sleep environment, situational stress, acute medical illness or pain, shift work, or

caff eine or alcohol use• Diagnosis can only be fi rmly made retrospectively after it has been relieved• Usually triggered by: Changes in sleep environment, high arousal states, poor sleep hygiene, short-term circadian

rhythm disorders including particularly by jet lag & rotating shift workChronic Insomnia Disorder• Insomnia persisting for at least 3 months w/ a frequency of at least 3 times per week• Consists of the former terms primary insomnia, secondary insomnia & comorbid insomnia• Patients w/ chronic insomnia should be evaluated for depressionRisk Factors• Increasing age

- Elderly individuals must be assessed for insomnia as they report more forms of sleeping diffi culty including lower rates of sleep effi ciency, longer sleep onset times, increased number of nighttime awakenings, more time in bed, earlier wake up times & more daytime naps

• Female gender• Medical & psychiatric disease (eg depression, mood disorders)• Socioeconomic factors (eg marital strain, fi nancial strain, unemployment)Common Comorbid Medical Disorders & Conditions• Neurological

- Stroke, Parkinson’s disease, dementia, seizure disorders, headache disorders, traumatic brain injury, chronic pain disorders, peripheral neuropathy, neuromuscular disorders

• Cardiovascular- Angina, congestive heart failure

• Pulmonary/Respiratory- Chronic obstructive pulmonary disease (COPD), emphysema, asthma, laryngospasm

• Gastrointestinal- Refl ux, peptic ulcer disease, cholelithiasis, colitis, irritable bowel syndrome

• Genitourinary- Incontinence, benign prostatic hypertrophy, interstitial cystitis

• Endocrine- Hyperthyroidism, hypothyroidism, diabetes mellitus

• Musculoskeletal- Rheumatoid arthritis, osteoarthritis, fi bromyalgia, Sjogren syndrome, kyphosis

• Reproductive- Pregnancy, menopause, menstrual cycle variations

• Sleep disorders- Obstructive sleep apnea, central sleep apnea, restless legs syndrome, periodic limb movement disorder,

circadian rhythm sleep disorders, parasomnias- Screen for obstructive sleep apnea using STOP Bang screening questionnaire: Ask about snoring, tiredness

during the day, observed apneic episodes, high blood pressure, body mass index >30 kg/m2, age >50 years, neck circumference >40 cm, & male gender

Common Comorbid Psychiatric Disorders• Mood disorders

- Major depressive disorder, bipolar disorder • Anxiety disorders

- Generalized anxiety disorders, panic disorder, posttraumatic stress disorder, obsessive-compulsive disorder• Psychotic disorders

- Schizophrenia, schizoaff ective disorder• Amnestic disorders

- Alzheimer’s disease, other dementias

Insomnia (5 of 13)

2 EVALUATION (CONT’D)

Common Medications or Substances Contributing to Insomnia• Antidepressants

- Fluoxetine, Paroxetine, Sertraline, Venlafaxine, Duloxetine, monoamine oxidase inhibitors• Stimulants

- Caff eine, Methylphenidate, amphetamine derivatives, Ephedrine & derivatives, cocaine• Decongestants

- Pseudoephedrine, Phenylephrine, Phenylpropanolamine• Narcotic analgesics

- Oxycodone, Codeine• Cardiovascular medications

- Beta-blockers, alpha-receptor agonists & antagonists, diuretics, lipid-lowering agents• Respiratory medications

- � eophylline, Albuterol• Alcohol• Corticosteroids

PRINCIPLES OF THERAPY

• If there are comorbidities, clinical judgment should decide whether the insomnia or the comorbid condition is treated fi rst or they can be treated at the same time- Choice of agent should be based on type of insomnia & presence of comorbidities

- Concomitant treatment of insomnia & psychiatric disorders is recommended to accelerate recovery & increase the likelihood of sustained response

- Other sleep disorders such as obstructive sleep apnea & restless leg syndrome may present w/ insomnia but will most likely not improve without treatment of the specifi c disorder

- Insomnia due to nocturia, pain or shortness of breath will most likely not improve without treatment of the medical disorder

Primary Treatment Goals• Improve sleep quality & quantity• Improve insomnia-related daytime dysfunction� e following may be measured using a sleep log & specifi c questionnaires to determine treatment outcomes: • Sleep onset latency (time to fall asleep following bedtime)• Total sleep duration• Number of nighttime awakenings• Sleep effi ciency• Satisfaction w/ sleep & reduction in sleep-related distress• Daytime functioning• Wake time after sleep onset• When patient forms a clear association between the bed & sleeping• ISI may be used to monitor the eff ect of treatment interventions

A NON-PHARMACOLOGICAL THERAPY

Use of non-pharmacological therapy alone or in combination w/ pharmacotherapy clinically improves insomniaCognitive Behavioral � erapy for Insomnia • First-line treatment for chronic insomnia in adults of any age• Combines cognitive therapy w/ behavioral treatments (eg sleep restriction, stimulus control, & sleep hygiene

education) & relaxation therapy • Reduces sleep onset latency & nocturnal awakenings, & improve sleep effi ciency• Studies have shown improvement in functional outcomes when used as adjunct to pharmacotherapy in patients

w/ insomnia w/ psychiatric or medical comorbidities

Insomnia (6 of 13)

A NON-PHARMACOLOGICAL THERAPY (CONT’D)

Sleep Hygiene Education/Psychoeducation• Targets environmental & lifestyle factors to build good habits which facilitate good sleep• More eff ective in patients w/ short-term insomnia• Sleep hygiene suggestions

- Maintain a regular-sleep wake schedule- Avoid naps lasting >1 hour or later than 3 pm & decrease the time spent in bed not sleeping (eg work,

telephone, internet)- Avoid excessive liquids or heavy evening meals- Avoid caff eine & nicotine 4-6 hours prior to bedtime- Do not use alcohol as a sleep aid- Avoid exercising within 3 hours of bedtime, but daytime physical activity particularly exercising 4-6 hours

prior to bedtime is encouraged to facilitate sleep onset- Minimize light, noise & excessive temperatures- Avoid watching the clock- Place digital devices far away from the bed to minimize intrusions to bedtime- Engage in a relaxing bedtime routine 30 minutes before sleep such as reading, listening to music, warm bath,

light snack or stretching- Avoid excessive worrying during bedtime, including sleep-related worries

Stimulus Control � erapy• Based upon the theory that insomnia is a conditioned response due to temporal (bedtime) & environmental

(bedroom/bed) cues that are associated w/ sleep • Aims to re-associate the bed/bedroom w/ sleep & to re-establish a consistent sleep-wake schedule• Bed & bedroom should be associated w/ rapid onset of sleep

- Go to bed only when sleepy- Use bed only for sleep (or sex) - Get out of bed & go to another room when unable to fall asleep within 20 minutes & return only when sleepy- Keep to a regular wake time regardless of duration of sleep the night before- Avoid daytime naps

Relaxation � erapy• Insomnia patients tend to have high levels of cognitive, physiologic, &/or emotional arousal both day & night• Two common techniques for relaxation therapy include progressive muscle relaxation & relaxation response• In progressive relaxation, patient gently contracts facial muscle for 1-2 seconds & then relaxes it

- � is process is repeated several times & then used in other muscle groups in the following sequence: Jaw & neck, upper arms, lower arms, fi ngers, chest, abdomen, buttocks, thighs, calves, & feet

• In relaxation response, patient begins by lying or sitting comfortably- W/ eyes closed, patient allows relaxation to spread throughout the body- A relaxed breathing pattern is established & thoughts are directed away from intrusive worries & toward a

neutral word or image• Diff erent relaxation methods work for diff erent people; it may take some trial & error & practice before the

best method for the patient can be identifi edCognitive � erapy• Identify faulty beliefs & attitudes about sleep & replace them w/ more helpful ones• Goal is to provide reassurance to patients regarding beliefs about sleep

- Attempt to decrease the cycle of insomnia, emotional distress, dysfunctional thoughts which can cause further sleep disturbances

Paradoxical Intention• Patient is advised to deliberately attempt to remain awake, thereby reducing the performance anxiety that is

believed to interfere w/ ability to initiate sleep• Aims to eliminate patient’s anxiety & tension about sleep performanceSleep Restriction � erapy• Goal is to decrease the amount of time in bed thereby increasing the percentage of time spent in bed asleep• Helpful for patients who have been increasing their time in bed hoping to increase their actual sleep time• Creates mild sleep deprivation which promotes shorter sleep onset & longer time asleep• It is recommended that sleep diaries be used for sleep time estimation, both before starting sleep restriction

therapy & also during follow-ups• Patient should stay in bed only as long as their average sleep time; but no less than 4 hours per night

- Allowable time in bed is increased by 15-20 minutes as sleep effi ciency improves- Time in bed is increased over a period of weeks until optimal sleep duration is achieved- Usually keep wake-up time the same & adjust bedtime

AInsomnia (7 of 13)

B PHARMACOLOGICAL THERAPY

• Considered as adjunctive therapy to non-pharmacological therapy• Prescribe the lowest eff ective dose & do not exceed the maximum recommended dose• Individualized drug regimen may be short-term or long-term but intermittent• Can be off ered if cognitive behavioral therapy is not suffi ciently eff ective or not available or when patient is

not motivated• Good sleep hygiene is still necessary• Avoid long-term nightly use• Regular follow-up is recommended to ensure eff ectiveness, monitor for side eff ects, dependence (both

psychological & physiological), & assess continuing need for medicationBenzodiazepines• Most commonly prescribed agents for treatment of insomnia

- May be used as adjunctive therapy w/ behavioral therapy• Proven eff ective for short-term insomnia treatment

- Reduce time to sleep onset; prolong stage 2 sleep; prolong total sleep time; may slightly reduce REM sleep- Decrease anxiety; impair memory; prevent seizure occurrence

• Use is usually limited to a 4-6 weeks duration only- Long-term use increases chances of habituation & withdrawal symptoms- Tolerance to hypnotic eff ects develops on repeated administration

• Rebound insomnia has occurred• Short-acting: Triazolam

- Has been associated w/ rebound anxiety & is therefore not fi rst line for insomnia- Suggested as a treatment for sleep onset insomnia

• Intermediate-acting: Estazolam, Temazepam- Temazepam is suggested as treatment for sleep onset & sleep maintenance insomnia

• Long-acting: Flurazepam, Quazepam• Diazepam is generally not used in the treatment of insomnia due to its long duration of eff ect & possibility of

accumulating active metabolites Non-benzodiazepine Hypnotics • Decrease sleep latency & number of awakenings• Improve sleep duration & sleep qualityEszopiclone• Longest half-life among benzodiazepine-like hypnotics: 5-7 hours• Eff ective for sleep onset & maintenance insomniaZaleplon• Suggested for treatment of sleep onset insomnia• Eff ective for patients w/ diffi culty in falling asleep but not in patients w/ diffi culty in maintaining sleepZolpidem• Suggested for treatment of sleep onset & sleep maintenance insomnia• Does not alter normal sleep patterns & is usually not associated w/ rebound insomniaZopiclone• Decreases sleep latency when compared to placebo & generally increases sleep duration without changing

normal sleep patternsMelatonin Receptor AgonistsMelatonin• Clinical trials data have shown that prolonged-release Melatonin improves sleep onset latency & quality in

patients >55 years old• Limited clinical data on use for chronic insomnia• May be benefi cial to patients w/ delayed sleep phase syndrome & in a subgroup of patients w/ low melatonin

levels- Limit use to a maximum of 3 months

Insomnia (8 of 13)

B PHARMACOLOGICAL THERAPY (CONT’D)

Melatonin Receptor Agonists (Cont’d)Ramelteon• Eff ective for sleep onset insomnia• Has no short-term usage restriction• Has not been associated w/ hypnotic side eff ects, withdrawal or rebound insomniaOrexin Receptor Antagonist• Eg Lemborexant, Suvorexant• Lemborexant was recently approved for the treatment of insomnia in adults that have diffi culties w/ sleep onset

&/or sleep maintenance• Suvorexant was suggested for treatment of sleep maintenance insomniaOther AgentsAntidepressants• Eg Amitriptyline, Dothiepin, Doxepin, Mirtazapine, Trazodone • Tricyclic antidepressants (TCAs) have been used in lower doses to treat insomnia in patients w/ comorbid

depressive disorders but are dangerous when overdosed• Doxepin is a suggested treatment for sleep maintenance insomnia• In some studies, low-dose Trazodone in conjunction w/ another full-dose antidepressant have moderate effi cacy

in improving sleep quality &/or durationAntiepileptics• Eg Gabapentin, Pregabalin• Limited evidence for effi cacy in the treatment of chronic insomnia• Gabapentin is used in patients w/ insomnia secondary to restless leg syndrome• Pregabalin has been found to improve sleep but the mechanism of action is unclearAntihistamines• Eg Diphenhydramine, Doxylamine• Generally less eff ective than benzodiazepines & are associated w/ daytime drowsiness• Not recommended for sleep onset & sleep maintenance insomnia due to limited evidence of effi cacyAntipsychotics• Eg Quetiapine• Quetiapine is the most frequently prescribed antipsychotic for insomnia but should only be considered in

patients w/ insomnia & comorbid mental health disorder

C FOLLOW-UP

Clinical reassessment should be done every few weeks &/or every month until insomnia resolves, then every 6 months thereafter• Follow-up during early stages of treatment is important to assess eff ectiveness, possible adverse reactions,

dependence & tolerance & the need for continuing treatment• Repeated use of self-administered questionnaires & survey instruments help in assessing outcome & in

determining the need for further treatment- Monitor sleep onset latency, sleep duration, sleep satisfaction & daytime functioning

• Consider reevaluation for comorbid disorders when behavioral therapies, pharmacological therapies & combined treatments have been ineff ective

• Consider referral to a sleep specialist if without improvement

Insomnia (9 of 13)

Dosage Guidelines

ANTIDEPRESSANTS

Drug Dosage Remarks

Doxepin 3-6 mg PO within 30 min before bedtimeMax dose: 6 mg/day

Adverse Reactions• CNS eff ects (sedation, dizziness, worsening of suicidal

thoughts or behavior, mild mydriasis); GI eff ects (nausea, gastroenteritis); CV eff ect (hypertension); Resp eff ect (upper resp tract infection)

Special Instructions • Use w/ caution in patients w/ history of suicide-related

events, epilepsy, head trauma, brain damage, alcoholism, severe CV disease, BPH, DM, sleep apnea, mild-moderate hepatic impairment

• Avoid using concomitantly w/ MAO inhibitors• Contraindicated in patients w/ mania, narrow-angle

glaucoma, & urinary retention

ANTIHISTAMINES

Drug Dosage Remarks

Diphenhydramine 25-50 mg PO 30 min before bedtime

Adverse Reactions• Antimuscarinic eff ects, GI disturbances, CV & CNS eff ects Special Instructions • For occasional use only • Use w/ caution in patients w/ angle-closure glaucoma,

prostatic hypertrophy, genitourinary obstruction, urinary retention, history of asthma, COPD, hyperthyroidism, hypertension or CV disease, myasthenia gravis, seizure disorder, severe renal or hepatic impairment

Doxylamine 25 mg PO within 30 min before bedtime x 2 wkMay be increased to 50 mg if necessary

Adverse Reactions• CNS eff ects (CNS stimulation, depression, headache, lack of

coordination, dizziness, psychomotor impairment); GI eff ects (N/V, constipation, diarrhea, epigastric pain, epigastric refl ux); CV eff ect (palpitation, arrhythmia); Resp eff ect (thickened resp tract secretions)

Special Instructions • Should be taken w/ food• Use w/ caution in patients w/ glaucoma, urinary retention,

hypotension, tinnitus, paresthesia

Promethazine 25 or 50 mg PO single nighttime dose

Adverse Reactions• CNS eff ects (drowsiness, dizziness, restlessness, headache,

disorientation, extrapyramidal eff ects); Dermatologic eff ects (rash, urticaria, pruritus); GI eff ects (anorexia, gastric irritation); CV eff ects (palpitation, hypotension, arrhythmias)

Special Instructions • Should be taken w/ or without food• Do not use in patients in coma, suff ering from CNS

depression of any cause, within 14 days of discontinuing MAO inhibitor therapy & in children <2 yr

• Use w/ caution in patients w/ asthma, severe CAD, narrow-angle glaucoma, epilepsy, hepatic & renal insuffi ciency

All dosage recommendations are for non-pregnant & non-breastfeeding women, & non-elderly adults w/ normal renal & hepatic function unless otherwise stated.

Not all products are available or approved for above use in all countries. Products listed above may not be mentioned in the disease management chart but have been

placed here based on indications stated in locally approved product monographs.Please refer to local product monograph in the latest copy of MIMS or in www.mims.com

for country-specifi c prescribing information.

Dosage Guidelines

BENZODIAZEPINES

Drug Dosage Remarks

Alprazolam 0.25-0.5 mg PO 8 hrlyUp to 4 mg/day PO in divided doses

Adverse Reactions• Dependence & withdrawal symptoms

can occur especially in patients w/ history of drug dependence

• CNS eff ects (sedation, drowsiness, muscle weakness, ataxia; less commonly, slurred speech, vertigo, headache, confusion); symptoms decrease after continued use- May cause complex sleep-related

behaviors (eg sleepwalking, sleep-driving)

• Prolonged use of agents w/ long half-lives may provide next-day anxiolytic action & decrease rebound hypertension but can also cause daytime sleepiness, cognitive impairment & incoordination

Special Instructions• Elderly patients should receive lower

doses• Short-term use (<4 wk) to avoid

dependence & withdrawal symptoms• Avoid use in patients w/ pre-existing

CNS depression, resp depression, acute pulmonary insuffi ciency, myasthenia gravis, or sleep apnea

• Use w/ caution in patients w/ chronic pulmonary insuffi ciency

Brotizolam 0.25 mg PO at bedtime

Chlordiazepoxide 5-10 mg PO 8 hrly or10-30 mg PO at bedtime

Diazepam 5-15 mg PO at bedtime

Dipotassiumclorazepate

5-10 mg PO at bedtime5-30 mg/day PO in divided doses

Estazolam 1-2 mg PO at bedtime

Flunitrazepam 0.5-2 mg PO at bedtime

Lorazepam 1-8 mg PO at bedtime

Lormetazepam 0.5-1.5 mg PO at bedtime

Midazolam 7.5-15 mg PO at bedtime

Nitrazepam 5-10 mg PO at bedtime

Oxazepam 15-25 mg PO at bedtime

Pinazepam 2.5-5 mg PO at bedtime

Temazepam 20 mg PO at bedtime

Triazolam 0.125-0.5 mg PO at bedtime

Insomnia (10 of 13)

Insomnia (11 of 13)

Dosage Guidelines

NON-BENZODIAZEPINE HYPNOTICS

Drug Dosage Remarks

Eszopiclone 1-2 mg PO at bedtimeMax dose: 3 mg/day

Adverse Reactions• CNS eff ects (headache, dizziness, pain,

nervousness); GI eff ects (unpleasant taste, xerostomia, dyspepsia, N/V, diarrhea); Other eff ects (rash, pruritus, infection, accidental injury)

• Dependence & withdrawal symptoms can occur especially in patients w/ history of drug dependence

• Anaphylaxis, angioedema & complex sleep-related behavior have been reported

Special Instructions • Eszopiclone has quick onset, so take

immediately before bedtime• Tablet should be swallowed whole• Do not take w/ a high fat meal or w/ alcohol• Use w/ caution in patients w/ resp compromise,

those receiving other CNS depressants or psychoactive medication

• Reduce dosage in patients w/ severe hepatic impairment

Zaleplon 5-10 mg PO at bedtimeMax dose: 20 mg/day

Adverse Reactions• CNS eff ects (amnesia, anxiety, dizziness,

hallucinations, somnolence, impaired coordination); Other eff ects (rash, photosensitivity reactions, peripheral edema, GI upset)

• Dependence & withdrawal symptoms can occur especially in patients w/ history of drug dependence

Special Instructions • Zaleplon has quick onset, so take immediately

before bedtime• Do not take w/ a high fat meal or w/ alcohol• Use w/ caution in patients w/ depression,

mild-moderate hepatic impairment, resp compromise, those receiving other CNS depressants or psychoactive medication

• Not recommended in patients w/ severe hepatic impairment

Insomnia (12 of 13)

Dosage Guidelines

NON-BENZODIAZEPINE HYPNOTICS (CONT’D)

Drug Dosage Remarks

Zolpidem 10-12.5 mg PO at bedtimeMax duration of treatment: 4 wk

Adverse Reactions• CNS eff ects (headache, drowsiness, dizziness, lethargy,

abnormal dreams, amnesia); Other eff ects (rash, GI upset)• Dependence can occur especially in patients w/ history of

drug dependence• Abnormal thinking/behavioral changes & complex

sleep-related behavior have been reportedSpecial Instructions • Zolpidem has quick onset, so take immediately before

bedtime• Do not take w/ a high fat meal or w/ alcohol• Use w/ caution in patients w/ resp compromise, those

receiving other CNS depressants or psychoactive medication

• Not recommended in patients w/ severe hepatic impairment, acute &/or severe resp insuffi ciency

Zopiclone 7.5-15 mg PO at bedtime Adverse Reactions• CNS eff ects (psychiatric & paradoxical reactions, amnesia,

rebound insomnia & withdrawal symptoms, somnolence, dizziness, headache); Other eff ects (bitter taste, GI upset)

Special Instructions • Same as Eszopiclone• Contraindicated in patients w/ severe hepatic impairment

MELATONIN RECEPTOR AGONISTS

Drug Dosage Remarks

Melatonin 2 mg PO at 1-2 hr before bedtime or1-2 sprays orally 24 hrly before bedtime

Adverse Reactions• CNS eff ects (dizziness, headache, fatigue, depression);

GI eff ects (nausea, unpleasant taste); Other eff ects (upper resp infection, myalgia, back pain, arthralgia)

Special Instructions • Tablet should be swallowed whole• Do not take w/ a high fat meal or w/ alcohol• Use w/ caution in patients w/ resp compromise, those

receiving other CNS depressants or psychoactive medication

• Use w/ caution in patients w/ mild to moderate hepatic impairment

• Contraindicated in patients w/ severe hepatic impairment & those currently taking Fluvoxamine

Ramelteon 8 mg PO at bedtime

Insomnia (13 of 13)

for country-specifi c prescribing information.Please see the end of this section for the reference list.

OREXIN RECEPTOR ANTAGONISTS

Drug Dosage Remarks

Lemborexant 5 mg PO before bedtime Max dose: 10 mg PO 24 hrly

Adverse Reactions• Somnolence• Sleep paralysis, hypnogogic/hypnopompic hallucination,

cataplexy-like symptoms & complex sleep behaviors (sleep-walking, sleep-driving, engaging in other activities while not fully awake) may occur

Special Instructions • Use w/ caution in patients w/ depression, suicidal ideation,

compromised resp function• Contraindicated in patients w/ narcolepsy• Suvorexant is not recommended in patients w/ severe

hepatic impairment

Suvorexant 10 mg PO within 30 min before bedtimeMax dose: 20 mg PO 24 hrly

Dosage Guidelines

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