About Insomnia

Understanding Insomnia
Understanding Insomnia
Insomnia Definition

American Psychiatric Association DSM 5 Criteria defines Insomnia as a condition in which people have difficulty falling asleep (DFA), difficulty staying asleep (DSA) and/or with early morning awakening (EMA).*

Insomnia Epidemiology

Symptoms occur in 33 to 50% of the adult population *,†

* Dopp JM, Phillips BG. Sleep–Wake Disorders. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGraw-Hill
† Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7-10.
America Insomnia Survey

* Walsh JK, Coulouvrat C, Hajak G, et al. Nighttime insomnia symptoms and perceived health in the America Insomnia Survey (AIS). Sleep. 2011;34(8):997- 1011.
The American Insomnia survey statistics

The American Insomnia survey found more respondents complaining about difficulty staying asleep (61%) and early morning awakening (52%) than difficulty falling asleep (38%).

Insomnia & Comorbidities
Insomnia & Depression*

Approximately 40% of adults with insomnia also have a coexisting psychiatric disorder, the most common being depression. Certain psychiatric conditions may be linked to Insomnia and can even be considered a diagnostic criteria. Psychological issues can lead to difficulty falling asleep, insomnia can lead to mood swings and shift in hormones. Studies suggest insomnia can trigger or worsen depression. The good news is that both conditions are treatable.

Insomnia & Anxiety*

Trouble falling asleep can cause someone to worry or be nervous. Certain anxiety symptoms that may lead to Insomnia include:

Anxiety may lead to problems with trouble falling asleep or maintenance of sleep throughout night. Once it starts happening on few occasions you may start feeling anxious and it triggers difficulty falling asleep. In patients comorbid with both, anxiety showed before insomnia in most instances. Various cognitive and mind-body techniques maybe helpful to people to facilitate falling asleep and relive anxiety.

Insomnia & Lifestyle

Unhealthy lifestyle and irregular sleeping habits can create or initiate causes that may lead to insomnia. Some specific lifestyle factors may include:

* Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7-10.
† Lopes CS, Robaina JR, Rotenberg L. Epidemiology of insomnia: prevalence and risk factors In: Sahoo S, editor. Can’t sleep? Issues of being an insomniac. Rijeka: InTech; 2012. p. 3-22.

Indications And Usage

DORAL is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

The effectiveness of DORAL has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of DORAL Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

Click Here for Important Letter to Healthcare Professionals in Response to FDA Warning Letter for Doral Promotional Materials

Important Safety Information ▲ expand
Indications & Usage ▲ expand

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug Interactions (7)]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Doral is contraindicated in patients with known hypersensitivity to Doral or other benzodiazepines, established or suspected sleep apnea, or pulmonary insufficiency. Doral can produce CNS depressant effects, including daytime impairment. Patients should be cautioned against driving and other activities requiring complete mental alertness. There is an increased risk of next-day psychomotor impairment if Doral is taken with less than a full night of sleep remaining (7-8 hours). The use of Doral and concomitant CNS depressants may require downward dose adjustment and the concomitant use of Doral with other sleep-hypnotics is not recommended. If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness. Rare cases of severe anaphylactic reactions including angioedema involving the tongue, glottis or larynx and dyspnea have been reported after treatment with Doral and are potentially fatal. Patients experiencing an anaphylactic or anaphylactoid reaction should be treated in an emergency department and should not be rechallenged. Behavior changes and complex behaviors such as “sleep driving” and “sleep eating” can occur with the use of sleep-hypnotics, and Doral should be discontinued if these symptoms occur. Benzodiazepines may worsen depression and consequently, appropriate precautions (e.g., increased monitoring, limiting prescription size) should be considered. Avoid abrupt discontinuation in at-risk patients of benzodiazepine withdrawal syndrome, particularly patients taking higher than recommended doses over an extended time. The most common adverse reactions (>1%) observed with Doral were drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia. Doral is classified as a Schedule IV controlled substance and patients treated with Doral should be monitored for tolerance, abuse, and dependence. For a full list of warnings and precautions, please refer to the full prescribing information.