INSOMNIA: DRUG (PHARMACOLOGICAL) TREATMENT.
By Cornelius Iwu PharmD RPh
Pharmacological therapy options for the treatment of chronic insomnia.
This is for informational use only
Insomnia affects over 30% of the population and is one of the most common sleep disorders there is. Some patients with chronic insomnia, describe the symptom as either inability to fall asleep (sleep-onset insomnia), inability to stay asleep (sleep maintenance insomnia), or both. Other sleep disorders include somnolence, restless leg syndrome RLS, sleep apnea, sleepwalking and eating, and night terrors. Risk factors that predispose patients to sleep disorders include age, work shift (overnight shifts), lower economic status, history of insomnia (familial), and genetic factors.
The purpose of this write-up is to help patients know what to expect from their providers when discussing/ deciding treatment modalities for their chronic insomnia. This perfectly fits the patient-centered healthcare approach which is shown to improve healthcare outcomes. Most African countries like Nigeria do not emphasize the importance of this approach in the practice of medicine. Some providers may need to conduct a sleep study to definitively diagnose a patient with chronic insomnia.
The need to discuss with your provider about the pharmacological approach to chronic insomnia is to evaluate/assess the risks vs benefits of this approach. Also evaluated are the risks of dependency, adverse drug reactions, and allergies.
It is important to note that a combination of cognitive-behavioral therapy CBT-I and pharmacological treatment approaches might prove to be beneficial compared to either approach alone, in the treatment of chronic insomnia. Although per the American Academy of Sleep Medicine consensus, the use of both approaches over one approach alone does not show a consistent advantage.
Problem falling asleep (sleep onset)
Problem staying asleep (sleep maintenance)
The above shows different medications that work for either sleep onset, sleep maintenance, or both.
- Short intermediate acting: Temazepam (Restoril), estazolam (prosom) or lorazepam (Ativan). These medications could cause drowsiness and dizziness.
- Temazepam: Per FDA, requests an update box warning about the potential for abuse, misuse, and addiction. Recommended dose for insomnia is 15- 30 mg PO (oral) QHS (bedtime). A dose as low as 7.5 mg could be effective for some patients.
- Estazolam: The recommended dose for insomnia is 1 mg PO QHS, 2 mg dose may be warranted. To mitigate withdrawal symptoms in patients on a high dose or extended dosing, tapering by 20% over 2 weeks is recommended.
2. Non-Benzodiazepines hypnotic sedative: the 3Z’s- Zolpidem, eszopiclone or Zaleplon.
- Eszopiclone (Lunesta): this medication has a black box warning of complex sleep behaviors such as sleepwalking, driving, and engagement in other activities while not fully awake. Recommended stopping this medication if the patient exhibits these complex sleep behaviors. Recommended initial dose of 1 mg PO QHS and can increase to a max effective dose, not to exceed 3 mg PO QHS, due to rapid onset of action, this medication should be given immediately before bedtime (patient should as well be in bed before taking this medication). This drug has a lot of disease-related concerns. Caution should be taken when patients with depression, respiratory disease (COPD), hepatic and renally impaired, and drug abusers are on this medication. Adverse effects associated with this medication include drowsiness, headache, dysgeusia- altered taste perception.
- Zolpidem (Ambien): this medication as well as the other 2 Z’s, targets the GABA receptors, decreases neural excitability leading to sedation and hypnotic effects. This medication also has a similar black box warning as eszopiclone. This medication is notoriously known for many litigations due to complex sleep behavior- hence “Ambien defense- Ambien made me to it.” This medication comes in ER and IR formulations. Recommended initial dose for sleep-onset insomnia is 6.25 mg ER PO QHS with at least 7 to 8 hours of planned sleep. Males can go up to 12.5mg PO QHS. Not to exceed 12.5 mg PO QHS. For IR formulation, recommended initial dose of 5 mg and males can go up to 10 mg PO immediately before QHS. Not to exceed 10 mg daily. For sleep maintenance insomnia, recommended initial dose both for IR and ER formulations- is the same as in sleep-onset insomnia. It is recommended to taper this medication and not to discontinue abruptly. Also recommended to take this medication in addition to CBT-I. Similar adverse drug reactions as found in eszopiclone, with palpitations and anxiety reported as well.
- Zaleplon (Sonata): Zaleplon has the same black box warning as seen in the other 2 Z’s. Act on the GABA receptor as well as the other 2Z’s. The recommended dose is 10 mg PO immediately before QHS, not to exceed 20 mg per day. This medication could be potentially inappropriate for the patient over the age of 65 due to concerns for fractures, falls and delirium. This medication has similar adverse effect profiles as the other 2Z’s.
3. Sedating antidepressants: Patients suffering from insomnia in the setting of depression, anxiety, or psychosis, could benefit from trazodone, amitriptyline, doxepin, or mirtazapine. Per AASM, due to insufficient data and studies, the use of antidepressants such as trazodone for insomnia is not recommended. However, it is common to see providers prescribe antidepressants for insomnia especially in patients with comorbid conditions such as psychosis, anxiety, and depression.
- Trazodone has an off-label use for the treatment of insomnia. The recommended dose is 50–100 mg PO QHS. A dose of up to 300 mg could be given to insomnia patients with depression.
- Doxepin, available in tablet and capsule forms is recommended for sleep maintenance insomnia with an oral dose of 3- 6 mg tablet PO once QHS within half an hour to bedtime. Not to exceed 6 mg per day. Dose of 10 mg capsule PO QHS.
Over The Counter (OTC)Agents:
The use of antihistaminic and analgesic agents for self-treatment of insomnia is common but this has unforeseen adverse effects and should not be encouraged. There have been documented stories of parents giving their children Benadryl to help put them to sleep for having tantrums. At high doses, Benadryl could cause seizures, heart problems, coma, and even death. Routine use of Benadryl for insomnia is not recommended. There are a few herbals and supplements used to help with sleep for instance valerian extract and melatonin. Melatonin is a “sleep hormone” neurohormone synthesized in the pineal gland- synthesized from tryptophan and acts on melatonin receptor; it is naturally produced in the body, with higher concentrations at night/ bedtime. Turkey contains a lot of tryptophan hence the reason why after eating Turkey, you feel sleepy. Some patients swear by melatonin for its efficacy. Some studies support this belief. Melatonin shortens the sleep onset by about 8 mins which could be priceless for some patients with insomnia.
In conclusion, insomnia continues to be a medical problem in our society today. Patients should consult and work with their provider to evaluate which treatment approach suits them. The difference between a drug and a poison is just in the dose (amount/concentration).
Read about the causes, symptoms and nonpharmacological treatment of insomnia here.
Cornelius Iwu is a Pharmacist and Polymer engineer by profession currently practicing in Boston.