Pharmacologic Management of Insomnia

Pharmacologic Management of Insomnia
Overview
Introduction Definitions Sleep Patterns in Insomnia Types of Insomnia Contributing Factors to Development Effects and Consequences Differential Diagnosis Indications for Treatment Treatment Goals Treatment Overview Treatment Options Selection of Treatment Agent Insomnia in the Elderly General Cautions Conclusion
Introduction
Approximately 1/3 of the US population complains of insomnia More than 40% of individuals suffering from insomnia self medicate with OTC medications or other substances such as alcohol Insomnia has historically been viewed as a symptom secondary to a medical condition but is now recognized as an independent disorder
William A. Kehue. General Psychiatry. In: Bressler L, Deyoung, G.R., El-Ibiary,S.,et al. Updates in Therapeutics: The Pharmacotherapy Preparatory Course, 2010 ed. Lenexa, KS: American College of Clinical Pharmacy 2010:331-335.
Definitions
NHLBI: Subjective patient complaint of difficulty falling asleep, difficulty staying asleep, poor quality sleep, or inadequate sleep despite adequate opportunity DSM-IV definition
Difficulty initiating or maintaining sleep for at least 1 month Nonrestorative sleep persisting for at least 1 month Accompanied by clinically significant impairment in daytime functioning
Research criteria
Sleep latency > 30 minutes Sleep efficiency < 85% Sleep disturbance > 3 times per week
National Institute of Health Statement Regarding the Treatment of Insomnia. Sleep. 2005;28:1049-1057. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med 2008 Oct 15;4(5):487-504.
Sleep Patterns in Insomnia

Sleep onset insomnia
Difficulty falling asleep Longer time to sleep onset
Sleep maintenance insomnia

Difficulty staying asleep Frequent nocturnal awakenings
Sleep offset insomnia

Waking too early in the morning
Non-restorative sleep
Fatigue despite adequate sleep duration
Kryger MH, Roth T, Dement WC, et al. Principals and Practice of Sleep Medicine. Philadelphia, PA: Elsevier Saunders; 2005.
Types of Insomnia
Type Duration 2 3 days < 3 weeks > 3 weeks Likely Causes Acute situation Environmental stressors Major life event Substance abuse Psychiatric illness Medical causes chronic illness Primary sleep disorder
Transient Short term Chronic
Transient: usually resolves when acute stressors are eliminated;

pharmacotherapy for a few days is an option
Short Term: may be due to stressor of ongoing nature; sleep hygiene

important, pharmacotherapy may be used (intermittent basis)
Chronic:
treat any underlying condition(s) that may be causing insomnia; initiate good sleep hygiene practice and pharmacotherapy indicated for long term use
Contributing Factors to Development

Predisposing factors Personality Sleep-wake cycle Circadian rhythm Coping mechanisms Age Perpetuating factors Conditioning Substance abuse Performance anxiety Poor sleep hygiene
Precipitating factors Situational Environmental Medical Psychiatric Medications

National Institute of Health Statement Regarding the Treatment of Insomnia. Sleep. 2005;28:1049-1057.
Effects and Consequences

Fatigue Moodiness Irritability or anger Daytime sleepiness Anxiety about sleep Lack of concentration Poor memory Lack of motivation or energy Headaches or tension Worsens psychiatric disorders Prolongs medical illnesses Reduced quality of life Higher absenteeism Increased accident risk Higher health care costs Cognitive impairment
Differential Diagnosis
Conditions Medications Alcohol Caffeine/chocolate Nicotine/nicotine patch BBs CCBs Bronchodialators Corticosteriods Decongestants Antidepressants Thyroid hormones
Hyperthyroidism Pain Cardiovascular disease Heartburn (GERD) Neurological Disorders Diabetes Menopause BPH Psychological
Indications for Treatment

Treatment is recommended when the chronic insomnia has a significant negative impact on a patients:
Sleep quality Health Co-morbid conditions Daytime function
Recognize and treat co-morbid conditions that commonly occur with insomnia Identify and modify behaviors and medications/substances that impair sleep
Treatment Goals
Primary Goals:
Improvement in sleep quality and time Improvement of insomnia-related daytime impairments
Other Goals:
Decreased frequency of awakenings Decrease in sleep related complaints Improvement in sleep related psychological distress
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med 2008 Oct 15;4(5):487-504.
Treatment Overview
Nonpharmacologic Therapy
Sleep Hygiene Cognitive behavioral therapies
Pharmacologic Therapy
Nonprescription agents
Anti-histamines Herbal supplements
Prescription agents
Antidepressants Antipsychotics Benzodiazepine-receptor agonists Melatonin-receptor agonists Benzodiazepines
Sleep Hygiene
Dont go to bed unless you are sleepy Get up at the same time every morning Get a full nights sleep on a regular basis (usually 7-8 hours for adults) Avoid taking naps if you can Keep a regular schedule Dont read, eat, watch TV, or talk on the phone Do not have any caffeine after lunch Do not have any alcohol within six hours of your bedtime Avoid smoking in the evening and right before bedtime Do not go to bed hungry Dont eat a big meal near bedtime either Avoid any tough exercise within six hours of your bedtime Avoid sleeping pills, or use them cautiously Try to get rid of or deal with things that make you worry Make your bedroom quiet, dark, and a little bit cool
First Generation Antihistamine

diphenhydramine (Benadryl)
No recent data of efficacy over 3 weeks; tolerance within a few days
Rapid tolerance to sedating effects Not for use in elderly patients Potential adverse effects
Residual effects Delirium Dry mouth Constipation Blurred vision Urinary retention Narrow angle glaucoma exacerbation
Herbal Products
Melatonin Valerian
Not recommended in the treatment of chronic insomnia due to the relative lack of efficacy and safety data Contamination with unknown substances is a problem with natural remedies
Bonnet MH, Arand DL. Treatment of Insomnia. In: UpToDate; 2010. Available at: http://www.uptodate.com. Accessed December 9, 2010.
Antidepressants
trazadone
Limited amount of data Sedating properties due to central anticholinergic and antihistaminergic activity Sedating antidepressants useful in the treatment of insomnia associated with depression Doses required for insomnia usually lower than doses used for depression Efficacy not entirely established in trials
doxepine
amitriptyline
Routine use of sedating antidepressants (except low dose doxepine) is not recommended
Sedating effect has tendency to be short-lived Side effects common
Atypical Antipsychotics
quetiapine (Seroquel)
Emerging case reports for PTSD and anxiety

Lack of data regarding the use for insomnia Option for patients with PTSD, at risk for addiction, and in the presence of agitation or psychosis Adverse effects: danger of precipitating weight gain, metabolic syndrome, or other adverse effects Doses typically significantly lower for the treatment of insomnia than for primary indications Unknown safety and efficacy of these agents when used off-label for the treatment of insomnia
Benzodiazepine Receptor Agonists

zolpidem (Ambien)
Short-term treatment Sleep onset insomnia
zolpidem ER (Ambien CR)

Not limited to short-term use Sleep onset AND sleep maintenance
zaleplon (Sonata)
Short-term treatment Sleep onset insomnia
eszopiclone (Lunesta)
Not limited to short-term use Sleep onset AND sleep maintenance
Benzodiazepine Receptor Agonists

Tolerance and abuse have not been shown to be a major problem in the general population Generally have shorter duration of action than most benzodiazepines
less likely to cause next day sedation
Side effects include:

Drowsiness Dizziness Unsteadiness of gait Rebound insomnia Memory impairment
Melatonin Receptor Agonist

Ramelteon (Rozerem)
FDA-approved for sleep onset insomnia Not limited to short-term use Little abuse potential Not a DEA controlled substance No rebound insomnia or withdrawal upon discontinuation Adverse events
Somnolence Dizziness Fatigue
Avoid in hepatic impairment Absolute Contraindication: co-administration with fluvoxamine

Benzodiazepines
triazolam (Halcion)* temazepam (Restoril)* estazolam (ProSom)* flurazepam (Dalmane)* quazepam (Doral)* clonazepam (Klonopin) lorazepam (Ativan) diazepam (Valium) alprazolam (Xanax)
* marketed for use as sedative-hypnotic agents
Benzodiazepines
Generally safe, effective, and well tolerated by patients All members of this class can be used as sedatives, but only 5 are marketed for this indication Used as sedative-hypnotics due to:
Rapid absorption CNS actions produced quickly
Problems with benzodiazepines

Tolerance Potential for abuse Residual daytime sedation Rebound insomnia Anteriograde amnesia Caution in elderly patients Withdrawal
Discontinuation Effects on Sleep

Hypnotic Agents
Rebound insomnia
Single symptom Exacerbation relative to baseline 1-2 night duration
Using smaller doses and tapering the drug can avoid rebound insomnia Withdrawal syndrome
Return of original symptom(s) At basal level of severity Longer duration
Selection of Treatment Agent

Mainly based on the type of insomnia (sleep onset, sleep maintainence) and duration of effect Sleep Onset Insomnia
Short-acting medication zaleplon, zolpidem, ramelteon
Sleep Maintenance Insomnia

Longer-acting medication zolpidem ER, eszopiclone, temazepam, estazolam, low dose doxepin
Consideration of specific agent also includes adverse effects, patient specific concerns, and cost
Insomnia in the Elderly

Sleep quality declines with age Insomnia not always due to aging Multiple factors affect sleep in the elderly
Nocturia Pain syndromes Medical disorders
Nonpharmacologic treatment should take precedence over pharmacologic treatment Hypnotics should be prescribed in lower doses than doses prescribed in younger patients
Drugs tend to have longer duration of effect due to changes in metabolism and elimination Increased incidence of falls and bone fractures (especially at night)
Passaro EA. Insomnia: Follow-up. Medscape. Available at http://emedicine.medscape.com/article/1187829-followup. Accessed 12/02/2010.
General Cautions
The smallest effective dose should always be used in therapy
Hypnotics should never be used with alcohol since this can produce excess sedation
Smaller doses should be used in elderly patients, and used very cautiously, if at all, in patients with risk of falls Caution with use in patients with a history of substance abuse Rebound insomnia may develop when the medication is withdrawn abruptly in some patients Some OTC medications like PM medications contain more than one medication
Conclusion
Insomnia is common condition, often co-morbid with other conditions and associated with significant morbidities
Impairments in daytime functioning, increase in risk for psychiatric illness, including depression, anxiety and other conditions are consequences of insomnia
Good sleep hygiene should be emphasized to all patients
Many of the most common drugs for insomnia are not FDA approved for that purpose
Limited duration of studies for insomnia medications No drug for insomnia is completely safe or free of the risk of side effects In the absence of evidence, need to match nature of sleep problem with treatment, availability, cost tolerance, side effect tolerance, and co-morbid conditions
References
1. 2. 3. 4. 5. William A. Kehue. General Psychiatry. In: Bressler L, Deyoung, G.R., El-Ibiary,S.,et al. Updates in Therapeutics: The Pharmacotherapy Preparatory Course, 2010 ed. Lenexa, KS: American College of Clinical Pharmacy 2010:331-335. National Institute of Health Statement Regarding the Treatment of Insomnia. Sleep. 2005;28:1049-1057. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med 2008 Oct 15;4(5):487-504. Kryger MH, Roth T, Dement WC, et al. Principals and Practice of Sleep Medicine. Philadelphia, PA: Elsevier Saunders; 2005. Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T, American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. Bonnet MH, Arand DL. Treatment of Insomnia. In: UpToDate; 2010. Available at: http://www.uptodate.com. Accessed December 9, 2010. Kryger MH, Roth T, Dement WC, et al. Principals and Practice of Sleep Medicine. Philadelphia, PA: Elsevier Saunders; 2005.
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Pharmacologic Management of Insomnia

Sleep Patterns in Insomnia

Sleep maintenance insomnia

Sleep offset insomnia

Transient Short term Chronic

Transient: usually resolves when acute stressors are eliminated;

Short Term: may be due to stressor of ongoing nature; sleep hygiene

Contributing Factors to Development

Precipitating factors Situational Environmental Medical Psychiatric Medications

Effects and Consequences

Indications for Treatment

First Generation Antihistamine

Emerging case reports for PTSD and anxiety

Benzodiazepine Receptor Agonists

zolpidem ER (Ambien CR)

Benzodiazepine Receptor Agonists

Side effects include:

Melatonin Receptor Agonist

Avoid in hepatic impairment Absolute Contraindication: co-administration with fluvoxamine

* marketed for use as sedative-hypnotic agents

Problems with benzodiazepines

Discontinuation Effects on Sleep

Selection of Treatment Agent

Sleep Maintenance Insomnia

Insomnia in the Elderly

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