Insomnia, Fatigue,

Drowsiness
SUKHVIR KAUR, PHARMD, BCACP
Learning Outcomes
Explain mechanism of action, dosing and administration,
dosage forms, adverse effects, drug interactions,
warnings/precautions, and contraindications of OTC agents
for insomnia, fatigue and drowsiness.

Identify first-line pharmacologic and nonpharmacologic

treatment recommendations for insomnia, fatigue and
drowsiness.
Nonprescription Medications
Regulated by the Center for Drug Evaluation and Research (CDER)
Held to same standards as prescription products
◦ Drug product formulation (purity, stability)
◦ Labeling
◦ Safety
 History of OTC Drug Regulation

Regulation of Nonprescription Drug Products: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM148055.pdf

 The OTC Label
Warnings:
-When not to use the product
-Conditions that may require advice
from a doctor before taking the
product
-Possible drug interactions
-Possible side effects
-When to stop taking the medicine
and when to contact the MD
Other information:
-How to store
-Required info for certain ingredients

Inactive ingredients:
- flavors, colors, filler, etc.
The OTC Label
Expiration date
Lot or batch code
Name and address of manufacturer, packer or distributor
Net quantity of contents
Statement explaining tamper-evident packaging
INSOMNIA
Explain mechanism of action, dosing and
administration, dosage forms, adverse
effects, drug interactions,
warnings/precautions, and
contraindications of OTC agents for
insomnia
Classification
Trouble falling asleep Transient
◦ < 1week
Trouble staying asleep
Short-term
Waking up too early and not being able to fall
back asleep ◦ 1-3 weeks

Not feeling refreshed after sleeping Chronic

◦ >3 weeks to years
Causes of Insomnia
 Acute life stress  Medical disorders
 Anxiety/depression
 Acute medical illness
 Restless legs syndrome
 Anxiety  Sleep apnea
 Poor sleep habits  Menopause
 Pregnancy
 Shift workers  BPH
 Drinking caffeine in late afternoon or  GERD
evening  COPD
 Exercising late in the evening
 Eating late-evening meal
 Environmental
 Causes of Insomnia – Medications
DRUGS CAUSING WITHDRAWAL
DRUGS CAUSING INSOMNIA INSOMNIA
 Alcohol
 Alcohol
 Anabolic steroids

 Antidepressants
 Amphetamines
 Anticonvulsants  Antihistamines (1st generation)
 Amphetamines
 Barbiturates
 Caffeine

 Corticosteroids  Benzodiazepines
 Decongestants  Opiates
 Diuretics

 Nicotine
 TCAs
 Thyroid preparations  Illicit drugs
Exclusions for Self-Care
<12 years of age
≥65 years of age
Pregnancy
Frequent nocturnal awakenings or early morning awakening
Chronic insomnia (> 3 weeks)
Secondary insomnia - sleep disturbance secondary to psychiatric or general medical disorder
Identify first-line pharmacologic and
nonpharmacologic treatment
recommendations for insomnia
Nonpharmacologic Therapy – Sleep
Hygiene
 Use bed for sleep and intimacy only
 Establish a regular sleep pattern: go to bed and wake up at same time every day
 Make bedroom comfortable: temperature, noise, light
 Participate in relaxing activity before bedtime
 Do not exercise within 2-4 hours of bedtime
 Exercise regularly
 Avoid large meals within 2 hours before bedtime (small snacks only)
 Avoid napping during the day
 Avoid caffeine, nicotine or alcohol 4-6 hours before bedtime
 If unable to fall asleep, get out of bed, do relaxing activity until tired
 Do not watch the clock at night
Pharmacologic Therapy
Antihistamines
Diphenhydramine and doxylamine
Diphenhydramine
 Dosing:
 50 mg at bedtime 30 to 60 minutes before sleep
 Some may benefit from 25 mg

 Maximum sedation occurs between 1 to 3 hours

 Significant drowsiness persists for 3 to 6 hours after a single dose of diphenhydramine 50 mg
 Tolerance to the sedative effect can occur as early as 4 days
 Can try using for 3 days, then take a night off to assess sleep quality without medication

 Should not be used for more than 7 to 10 consecutive nights

 Birth control + diphenhydramine   birth control effectiveness
Team Activity – 10 minutes
Write 3 counseling points for the use of DIPHENHYDRAMINE
Write 3 side affects associated with DIPHENHYDRAMINE
Provide brand names of medications that contain DIPHENHYDRAMINE including combination
products
Team Activity
Doxylamine
Dosing:
◦ 25 mg 30 minutes before going to bed
Anticholinergic ADE vs Toxicity
ADVERSE DRUG EFFECTS (ADE) TOXICITY

Dry mouth Anxious, excited, delirious, hallucination

Blurred vision Coma/seizure
Constipation QT prolongation, tachycardia
Urinary retention Dilated pupils, flushed skin, hot/dry mucous
“hang over” effect (next day)

TX: Monitoring, ADE acceptable TX: Gastric lavage, activated charcoal (gastric
tube), supportive tx
Contraindications to anticholinergics
BPH
CVD (angina, uncontrolled HTN)
Closed angle glaucoma
Dementia
Parkinson’s disease
Liver disease

****Look carefully at the patient profile and DO NOT RECOMMEND self care treatment*******
Patient Need Referral!!!!
Ethanol
 Use of alcohol to induce sleep is common in patients with chronic insomnia
 Initially improves sleep in people who do not abuse alcohol but sleep disturbances occur in
the second half of the night at high doses
 Tolerance quickly develops
 In heavy/continuous use
 Restless sleep, often awaken within 2 to 4 hours
 Have reduced total sleep duration
 Worsening of sleep or rebound insomnia can occur when alcohol use ceases

 Nyquil liquid has alcohol in the product to induce sleep (10% alcohol by volume)
 Data are limited regarding efficacy and safety of these products as hypnotics
Complementary Therapies (CAMs)
Melatonin
◦ May be effective in short-term treatment of delayed sleep phase syndrome (i.e., a sleep pattern
characterized by a delayed onset of sleep by 2 or more hours from normal, resulting in a later bedtime
and wake time).

Valerian
Kava
◦ Should not be recommended due to severe hepatotoxicity
Question #1
What are the most common side effects of diphenhydramine?
Question #2
Who should avoid using diphenhydramine?
Question #3
Should a 9 year old use diphenhydramine for sleep?

Should a 70 year old use diphenhydramine for sleep?

FATIGUE AND DROWSINESS
Explain mechanism of action, dosing and
administration, dosage forms, adverse
effects, drug interactions,
warnings/precautions, and
contraindications of OTC agents for
fatigue and drowsiness
Contributing Factors
A homeostatic process involving an increase in sleepiness as time since the most recent period
of sleep increases
A circadian process by which the master biologic clock in the suprachiasmatic nucleus varies
alertness over the course of the 24-hour day
CNS depressants – antihistamines, antipsychotics, anticonvulsants, and opioids
Clinical Presentation
Yawning
Eye rubbing
Tendency to fall asleep
Decreased ability to focus and concentrate
Treatment Goal
Identify and eliminate the underlying cause to improve mental alertness and productivity
Explain mechanism of action, dosing and
administration, dosage forms, adverse
effects, drug interactions,
warnings/precautions, and
contraindications of OTC agents for
fatigue and drowsiness
Nonpharmacologic Treatment
Good sleep hygiene principles
Caffeine
Dosing: adults and children 12 years of age and
older is 100-200 mg every 3-4 hours as needed
Help restore mental alertness or wakefulness
Rapid tolerance
Side effects: respiratory, cardiovascular side
effects
Withdrawal symptoms: headache, fatigue,
decreased concentration, and irritability, starting
within 12-24 hours after cessation and persisting
for 1-5 days
Avoid in children <12, caution in pregnancy and
nursing, patients with heart disease or patients
with anxiety
Caffeine cautions
Caution with weight loss supplements and
energy sport drinks
Natural products that have caffeine such as
guarana, green tea, yerba mate, and cola nut
Total daily caffeine intake should be limited to
less than 200 mg during pregnancy
Caffeine Toxicity
Increases in heart rate and blood pressure
Headache
Symptoms of anxiety and insomnia
Increase in hand tremor

*****Require medical attention immediately*******

Ginseng
May help boost physical and mental energy and a sense of well-being however data is limited.
Team Activity – 10 minutes
Write 3 counseling points for the use of CAFFEINE
Write 3 side effects associated with CAFFEINE
Provide brand names of medications that contain
CAFFEINE including combination products
Team Activity
Medications of the Day (41-50)
Amitriptyline Hydrochloride
Ativan®
Esomeprazole Magnesium
Zantac®
Duloxetine Hydrochloride
Catapres® and Catapres® TTS
Sulfamethoxazole with Trimethoprim
Percocet®, Roxicet®, Endocet®
Divalproex Sodium
Lantus®
Learning Outcomes
Explain mechanism of action, dosing and administration,
dosage forms, adverse effects, drug interactions,
warnings/precautions, and contraindications of OTC agents
for insomnia, fatigue and drowsiness.

Identify first-line pharmacologic and nonpharmacologic

treatment recommendations for insomnia, fatigue and
drowsiness.
Any Questions?
skaur@cnsu.edu